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Oncology Example 2:
Non-Hodgkins Lymphoma: Post-Chemotherapy Tumor Reduction

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Table of Contents

(A small sampling of results from a January 3 to January 9, 2008 MIB Abstract Alert search)

Archived Abstracts

Go to Archive


Summary

Abbott Labs
Gengraf OR Neoral OR Sandimmune / cyclosporine & Abbott
Humira / adalimumab & Abbott
Accentia BioPharmaceuticals
BiovaxID & Accentia
Abstract Title Lead Author Publication Pub Date
Accentia Biopharmaceuticals Complies with Nasdaq Marketplace Rule 4350(b)(1)(B) [none given] Business Wire. New York 2008-01-04
Accentia Biopharmaceuticals Reaffirms its Confidence in the Ongoing Unblinding of the BiovaxID(TM) Phase 3 Data Based on a Track Record of Eliciting an Immune Response in 80% of Patients [none given] Lab Business Week 2008-01-06
Return to ToC
Amgen / Wyeth
Enbrel / etanercept & Amgen
Aventis Pharmaceuticals
Arava / leflunomide & Aventis
Bristol-Myers Squibb Oncology
Platinol / cisplatin & Bristol-Myers
Cell Therapeutics
Abstract Title Lead Author Publication Pub Date
NIRI Seattle -- January 15th, 2008 Chapter Meeting [none given] Business Wire. New York: Jan 9, 2008. 2008-01-09
Return to ToC
Pixantrone / BBR2778 & CTI
Zevalin / Ibritumomab tiuxetan & CTI
Abstract Title Lead Author Publication Pub Date
Research from P.F. Ferrucci and co-authors reveals new findings on non-hodgkin lymphoma [none given] Biotech Week 2008-01-09
Cell Therapeutics, Inc.Enhanced Coverage LinkingCell Therapeutics, Inc. -Search using: [none given] Biotech Week 2008-01-09
House and Senate Pass Medicare Legislation to Freeze 2008 Reimbursement for Therapeutic Radiopharmaceuticals at 2007 Levels [none given] Aging & Elder Health Week 2008-01-06
Return to ToC
Centocor
Remicade / infliximab & Centocor
Connetics Corporation
Ridaura / auranofin & Connetics
Genentech / Biogen Idec
Abstract Title Lead Author Publication Pub Date
Progressive Following on Biogen Idec Inc [none given] M2 Presswire. Coventry: 2008-01-07
Research from Biogen Idec, Inc. yields new findings on non-hodgkin lymphoma [none given] Healthcare Mergers, Acquisitions & Ventures Week 2008-01-05
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Rituxan / rituximab & Genentech
Abstract Title Lead Author Publication Pub Date
High level expression of a functional human/mouse chimeric anti-CD20 monoclonal antibody in milk of transgenic mice. Tang B Transgenic Res. 2008-01-09
Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma [none given] Biotech Week 2008-01-09
Genmab
Ofatumumab & Genmab
HuMax (CD4, CD32b, CD20) & Genmab
Abstract Title Lead Author Publication Pub Date
Genmab has Announced a New Pre-Clinical Antibody Program Called HuMax-CD32b. [none given] PR Newswire. New York: 2008-01-04
Return to ToC
GlaxoSmithKline
Bexxar / tositumomab & GlaxoSmithKline
Hoffmann-La Roche
Ocrelizumab & Hoff.-La Roche
Medicis
Dynacin, Minocin, Vectrin / minocycline & Medicis
Pfizer Pharmaceuticals
Azulfidine / sulfasalazine & Pfizer
Prometheus Laboratories
Imuran / azathioprine & Prometheus
Seattle Genetics
SGN-40 (in Combination with Rituxan) & Seattle Gen.
Abstract Title Lead Author Publication Pub Date
Genentech begins NHL trial with SGN-40 triggering milestone payment to SG [none given] Pharma Agreement News 2008-01-08
Seattle Genetics to Present at the 26th Annual JPMorgan Healthcare Conference [none given] Business Wire. New York: 2008-01-04
Return to ToC
Schering-Plough
Solganal / aurothioglucose & Scher.-Plough
Lymphoma (Non-Hodgkin's)
Anthracycline & Lymphoma
Cluster of Differentiation 20 (CD20) antibody & Lymphoma
Anti CD20 Monoclonals & Lymphoma
Abstract Title Lead Author Publication Pub Date
Reports from University of Illinois highlight recent research in monoclonal antibodies [none given] Drug Law Weekly 2008-01-08
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CD20 positive, follicular & Lymphoma
Abstract Title Lead Author Publication Pub Date
Study data from E. Domingodomenech and co-authors update knowledge of lymphoma [none given] Hematology Week. Atlanta: 2008-01-07
Study data from American University of Beirut, Department of Anesthesiology update understanding of lymphoma [none given] Stem Cell Week. Atlanta: 2008-01-07
Researchers from Kyungpook National University, Medical Department describe findings in non-hodgkin lymphoma [none given] Stem Cell Week. Atlanta: 2008-01-07
Sun deters cancer risk [none given] Townsville Bulletin. Townsville, Qld. 2008-01-05
Jefferson to study intravenous Vitamin C vs. cancer Marie McCullough. McClatchy - Tribune Business News. Washington: 2008-01-03
Studies from American Cancer Society in the area of cancer described [none given] Aging & Elder Health Week 2008-01-06
Research from Tilburg University provide new insights into non-hodgkin lymphoma quality of care [none given] Aging & Elder Health Week 2008-01-06
Return to ToC
Chimeric Monoclonal Antibody (CMA) & Lymphoma
Abstract Title Lead Author Publication Pub Date
Reports from Xiamen University describe recent advances in lymphoma [none given] Biotech Week 2008-01-09
Return to ToC
Humanized Ocrelizumab & Lymphoma
Humanized Ofatumumab & Lymphoma
Leukemia & Lymphoma
Abstract Title Lead Author Publication Pub Date
CEBPA polymorphisms and mutations in patients with acute myeloid leukemia, myelodysplastic syndrome, multiple myeloma and non-Hodgkin's lymphoma. Fuchs O Blood Cells Mol Dis. 2008-01-06
IgA nephropathy associated with leukemia and lymphoma: report of two cases. Motoyama O Clin Exp Nephrol. 2008-01-05
Data on acute leukemia therapy described by researchers at Yokohama City University, Department of Pediatrics [none given] Hematology Week. Atlanta: 2008-01-07
Return to ToC
Neoplastic Disease & Lymphoma
Abstract Title Lead Author Publication Pub Date
Leukemia Presenting as Solid Tumors Urs L Pediatr Dev Pathol. 2008-01-07
Return to ToC
Tumor Reduction & Lymphoma
Abstract Title Lead Author Publication Pub Date
Frequent microsatellite instability in non-Hodgkin lymphomas irresponsive to chemotherapy. Miyashita K Leuk Res. 2008-01-03
Return to ToC
non-Hodgkin's lymphoma
B cell & non-Hodgkin's lymphoma
Abstract Title Lead Author Publication Pub Date
Non-Hodgkin lymphoma related to hereditary nonpolyposis colorectal cancer in a patient with a novel heterozygous complex deletion in the MSH2 gene. Pineda M Genes Chromosomes Cancer. 2008-01-07
B-cell identity--commitment is not forever. Nutt SL. N Engl J Med. 2008-01-03
Studies from National Cancer Institute reveal new findings on cancer [none given] Clinical Oncology Week. Atlanta: 2008-01-07
Kiadis Pharma Reports Successful End of Phase II Meeting With FDA for Reviroc [none given] Blood Weekly. Atlanta: 2008-01-03
Genitope Corporation Reports Initial Results of Phase 3 Clinical Trial of MyVax(R) Personalized Immunotherapy [none given] Blood Weekly. Atlanta: 2008-01-03
New B-cell lymphoma study findings have been reported by investigators at Research Center [none given] Biotech Week 2008-01-09
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downregulat* & B cell
CD20 & B cell
Tumor Reduction & B cell
Relapsed Follicular & non-Hodgkin's lymphoma
Abstract Title Lead Author Publication Pub Date
Investigators at Cleveland Clinic have published new data on follicular lymphoma [none given] Biotech Week 2008-01-09
MethylGene/Pharmion start Phase II trial of MGCD0103 in combination with Vidaza [none given] Cancer Drug News 2008-01-09
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Marginal Zone & non-Hodgkin's lymphoma

Full Abstracts

Abbott Labs
Gengraf OR Neoral OR Sandimmune / cyclosporine & Abbott
Humira / adalimumab & Abbott
Accentia BioPharmaceuticals
BiovaxID & Accentia

Accentia Biopharmaceuticals Complies with Nasdaq Marketplace Rule 4350(b)(1)(B)

Lead Author: [none given]

Business Wire. New York: , 2008-01-04

Accentia Biopharmaceuticals, Inc., Tampa

Douglas Calder, Director of Investor Relations & Public

Relations, 813-864-2554, ext.258

dwcalder@accentia.net

or

Susan Bonitz, Ph.D., Director, Program Coordination

813-864-2554, ext.277

sbonitz@accentia.net

Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), in compliance with Nasdaq Marketplace Rule 4350(b)(1)(B), which requires separate disclosure of receipt of an audit opinion that contains a going concern qualification, disclosed that its Annual Report (Form 10-K) for the fiscal year ended September 30, 2007 contains a going concern qualification from its independent registered public accounting firm, Aidman, Piser & Company, P.A. As in the past, Accentia continues to consolidate its financial statements with its majority-owned subsidiary, Biovest International, Inc., although it is not funding Biovest. This audit opinion is consistent with previous opinions included in the Company's 2005 and 2006 financial statements, which reflect the continued developmental stage of Accentia's consolidated business with Biovest.

This announcement does not represent any change or amendment to the Company's fiscal 2007 financial statements or to its Annual Report, filed on Form 10-K, with the SEC on December 28, 2007.

About Accentia Biopharmaceuticals, Inc.

Accentia Biopharmaceuticals, Inc. is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune(TM), to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.

For further information, please visit http://www.Accentia.net.

MIB Abstract ID Number: 14343

Proquest Identifier: 1407894261

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Accentia Biopharmaceuticals Reaffirms its Confidence in the Ongoing Unblinding of the BiovaxID(TM) Phase 3 Data Based on a Track Record of Eliciting an Immune Response in 80% of Patients

Lead Author: [none given]

Lab Business Week, 2008-01-06, EXPANDED REPORTING; Pg. 127

Accentia Biopharmaceuticals announced that it is reaffirming its confidence in the results of the ongoing unblinding of the BiovaxID(TM) pivotal Phase 3 results. Yesterday, Genitope Corporation announced that its recombinant partial copy of the tumor specific antigen for non-Hodgkins lymphoma, MyVax(R), elicited an immune response in just 40% of patients and that its Phase 3 clinical study of MyVax failed to meets its primary endpoint of statistically significant progression free survival vs control group.

 

Accentia's BiovaxID differs significantly from MyVax and other recombinant products. BiovaxID is a hybridoma-produced full copy of the tumor specific antigen that has demonstrated in a Phase 2 study at the National Cancer Institute and in an independent study at the University of Navarra to elicit an immune response in 80% of patients.

According to Dr. Steve Arikian, M.D., Chairman and CEO of Biovest International, the majority-owned subsidiary of Accentia that holds the worldwide exclusive rights to BiovaxID, "We believe that a strong immune response from a broad population of lymphoma patients requires a complete copy of the tumor specific antigen to induce long lasting disease free survival. This is why we have consistently demonstrated an 80% immune response."

Accordingly, Accentia reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect. Accentia believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the U.S. under subpart E and conditional approval in the EU. The company is also examining molecular remission data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the U.S. and EU, respectively.

The public release of the unblinding of the BiovaxID data is expected in April, 2008.

MIB Abstract ID Number: 14359

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Amgen / Wyeth
Enbrel / etanercept & Amgen
Aventis Pharmaceuticals
Arava / leflunomide & Aventis
Bristol-Myers Squibb Oncology
Platinol / cisplatin & Bristol-Myers
Cell Therapeutics

NIRI Seattle -- January 15th, 2008 Chapter Meeting

Lead Author: [none given]

Business Wire. New York: Jan 9, 2008. , 2008-01-09

Investor Relations Veterans Best Practices Panel Discussion

For NIRI Seattle

Frank Lane, 425-458-3074

The Seattle Chapter of the National Investor Relations Institute (NIRI) is hosting an interactive panel discussion with veteran investor relations and communications professionals who will provide in-depth knowledge on a variety of topics based on their experience and attendee questions. Please join us for the first program of 2008!

The luncheon will be held Tuesday, January 15, 2008 at the Washington Athletic Club in Seattle, from 11:45 AM to 2:00 PM PST.

*** Click Here to view the full text of this abstract ***

MIB Abstract ID Number: 14367

Proquest Identifier: 1410305011

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Pixantrone / BBR2778 & CTI
Zevalin / Ibritumomab tiuxetan & CTI

Research from P.F. Ferrucci and co-authors reveals new findings on non-hodgkin lymphoma

Lead Author: [none given]

Biotech Week, 2008-01-09, EXPANDED REPORTING; Pg. 1141

According to recent research published in the British Journal of Haematology, "Radioimmunotherapy (RIT) is an alternative approach in the treatment of resistant/refractory B-cell non-Hodgkin lymphoma (NHL). We performed a feasibility and toxicity pilot study of escalating activity of Y-90-ibritumomab tiuxetan followed by autologous stem cell transplantation (ASCT)."

"Three activity levels were fixed - 30 MBq/kg (0.8 mCi/kg), 45 MBq/kg (1.2 mCi/kg) and 56 MBq/kg (1.5 mCi/kg) - and 13 patients enrolled. One week before treatment all patients underwent dosimetry. ASCT was performed 13 d after Zevalin((R)) administration. Treatment was well tolerated and all patients engrafted promptly. No differences in terms of haematological toxicities were observed among the three levels, apart from a delayed platelet recovery in heavily pretreated patients receiving 56 MBq/kg. Non-haematologic toxicity was mainly related to infections and liver toxicity. One patient died 4 months after treatment because of hepatitis C virus reactivation. One patient developed a myelodysplastic syndrome 2 years after treatment," wrote P.F. Ferrucci and colleagues.

The researchers concluded: "High-activity Zevalin((R)) with ASCT is feasible and could be safely delivered in elderly and heavily pretreated NHL patients, including those who previously received high-dose chemotherapy and ASCT. Maximum tolerated dose was not clearly defined according to dosimetry and clinical toxicities, and further studies are needed to confirm the toxicity profile and evaluate efficacy."

Ferrucci and colleagues published their study in British Journal of Haematology (High activity Y-90-ibritumomab tiuxetan (Zevalin(R)) with peripheral blood progenitor cells support in patients with refractory/resistant B-cell non-Hodgkin lymphomas. British Journal of Haematology, 2007;139(4):590-599).

For additional information, contact P.F. Ferrucci, European Institute Oncology, Clinic Translat Research Program, Melanoma & Sarcoma Division, Via Ripamonti 435, I-20100 Milan, Italy.

The publisher's contact information for the British Journal of Haematology is: Blackwell Publishing, 9600 Garsington Rd., Oxford OX4 2DQ, Oxon, England.

MIB Abstract ID Number: 14352

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Cell Therapeutics, Inc.Enhanced Coverage LinkingCell Therapeutics, Inc. -Search using:

Lead Author: [none given]

Biotech Week, 2008-01-09, EXPANDED REPORTING; Pg. 2686

Cell Therapeutics, Inc. (CTI) (Nasdaq, MTAX: CTIC) announced that it has completed its acquisition of Zevalin(R) (ibritumomab tiuxetan) from Biogen Idec, giving CTI sole responsibility for marketing, sales, and development of the drug in the United States. Zevalin will continue to be sold outside the United States by Bayer Schering under an agreement between Biogen Idec and Bayer Schering. Approved in 2002 to treat patients with relapsed indolent non-Hodgkin's lymphoma (NHL), Zevalin was the first radioimmunotherapy to be approved by the U.S. Food and Drug Administration (FDA). In 2006, Biogen Idec reported $16.4 million in U.S. Zevalin sales.

 

"This acquisition puts CTI back into the commercial arena, which is a relatively exclusive space for biotech companies, and also strengthens our product pipeline," said James A. Bianco, M.D., President and CEO of CTI. "Adding the commercial infrastructure now may also provide a benefit to the company for future launches of other products in our pipeline. This is especially relevant to the potential launch of pixantrone and its expected synergies with Zevalin."

CTI made an initial payment of $10 million to Biogen Idec in exchange for control of U.S. marketing, sales, and development of Zevalin. Under the terms of the acquisition agreement, CTI will pay royalties to Biogen Idec based on the net sales of Zevalin until at least December 2015, and has also agreed to pay up to an additional $20 million in milestone payments if the product receives approval from the FDA for certain first-line indications in NHL. CTI also has agreed to share the cost of certain clinical trials of Zevalin with Bayer Schering in the event such trials are undertaken. CTI was advised on the transaction by CIBC World Markets Corp.

"Zevalin is a highly effective drug now, with attractive long-term commercial potential as front-line consolidation therapy in follicular and diffuse B-cell lymphoma. Potential label expansion into first-line treatment for NHL in the U.S. could help boost sales significantly," Dr. Bianco added.

Fong Appointed as Vice President, Commercial Operations

Dr. Bianco also announced that Jim Fong has joined the company as Vice President of Commercial Operations and will be leading the commercial operation for Zevalin.

Most recently, Fong was Senior Director of Brand Marketing at CV Therapeutics, Inc. (CVT), where he managed a sales team of more than 200, including business managers, marketing and sales operations and the sales training department. Prior to CVT, Fong directed several sales teams and has previous oncology experience launching Camptosar at Pharmacia. Fong holds a B.S. from University of California, Los Angeles in Psychology.

"Jim did a great job at the launch of Ranexa and streamlining CVT's commercial operations. With his prior expertise in marketing and sales, and the launch of a novel blockbuster anti-cancer agent Camptosar(R), Jim has the ideal credentials to lead a successful sales and marketing effort for Zevalin while optimizing the positioning of our future oncology products like pixantrone," noted Dr. Bianco.

"I am very pleased to join the CTI team and help re-establish a strong sales and marketing presence for the company," said Fong. "Zevalin is a great product and CTI is on an upward growth path with multiple opportunities for product launches in the coming years."

Seattle leaders praised the acquisition as a boost for the local biotech community.

"CTI is on a growth path with its acquisition of Zevalin. Patients will benefit, knowing they have continued access to this proven drug. Becoming a commercial company again is good news for CTI as well as for the Seattle biotech community," said Jack Faris, President of the Washington Biotechnology & Biomedical Association.

"Building a vibrant biotech community is an important part of the city's and the state's business strategy. Companies like CTI are helping to build our economic infrastructure for the future," said Jan Drago, Seattle City Council.

MIB Abstract ID Number: 14353

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House and Senate Pass Medicare Legislation to Freeze 2008 Reimbursement for Therapeutic Radiopharmaceuticals at 2007 Levels

Lead Author: [none given]

Aging & Elder Health Week, 2008-01-06, EXPANDED REPORTING; Pg. 122

New Medicare legislation passed by the House and Senate extends the 2007 reimbursement methodology for radiopharmaceuticals into 2008. The Centers for Medicare and Medicaid Services (CMS) had implemented new hospital outpatient reimbursement rates for 2008 for radiopharmaceuticals like ZEVALIN(R) (Ibritumomab Tiuxetan) below their acquisition costs. The drugs are used to fight relapsed non-Hodgkin's lymphoma, which for some patients can provide additional therapeutic options. The new Medicare legislation will maintain the current methodology for reimbursement of therapeutic radiopharmaceuticals for the first six months of 2008, giving the drugs' manufacturers and CMS time to seek a permanent reimbursement procedure that more accurately reflects hospital costs associated with the therapy.

"We applaud law makers for responding to the concerns of patients and providers regarding these important therapeutic options for treating patients with this deadly disease," said CTI President and CEO James A. Bianco, M.D. "This legislation will maintain the status quo and provide the drug manufacturers the opportunity to work with CMS on developing an equitable methodology for reimbursing therapeutic radiopharmaceuticals."

Cell Therapeutics, Inc. (CTI) (Nasdaq: MTAX) has signed an agreement to acquire the U.S. marketing, sales and development rights to ZEVALIN from Biogen Idec, which it expects to close later this month. Until the transaction is closed, ZEVALIN remains a product and trademark of Biogen Idec, Inc.

MIB Abstract ID Number: 14357

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Centocor
Remicade / infliximab & Centocor
Connetics Corporation
Ridaura / auranofin & Connetics
Genentech / Biogen Idec

Streetinvesting.com: Progressive Following on Biogen Idec Inc

Lead Author: [none given]

M2 Presswire. Coventry: , 2008-01-07, pg. 1

M2 PRESSWIRE-January 7, 2008-Streetinvesting.com: Progressive Following on Biogen Idec Inc (C)1994-2008 M2 COMMUNICATIONS LTD

Stocks lost ground Friday following the government's much anticipated report on the country's employment outlook which stated a weaker-than-expected job growth and a definite rise in the unemployment rate. The jobless rate hit a 2-year high at 5 percent only to further add fuel to recession fears. The report went on to say that the reasons for the deteriorating employment conditions were due to a housing slump and a credit crunch adding to further draining the strength of the economy.

Biogen Idec Inc (NASDAQ:BIIB) traded up $1.17 early Monday morning, with average volume.

Our research resources have been aimed towards the US Large Caps and the various prospective companies therein. Biogen Idec Inc was among those that we have been closely examining due to their recent news and trading patterns.

Jan 7th 2008, In a presentation to investors at the 26th Annual JPMorgan Healthcare Conference in San Francisco, Biogen Idec Inc. CEO James C. Mullen will outline the company's key growth opportunities, long-range strategy and financial goals. Mullen is scheduled to speak at 4 p.m. PST today, and the presentation will be available via webcast on the Investor Relations section of www.biogenidec.com. Supplemental information in the form of a slide presentation will also be accessible on the Biogen Idec website at the time of the presentation and will remain available until at least February 6, 2008.

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Friday saw the price of gold continuing its record breaking run as investors worry about a weak dollar and tensions around the world. The service sector grew slightly in the month of December indicating additional evidence that the U.S. economy is struggling due to higher oil prices and a tight credit market. However, the price of gold is continuing its record breaking run as investors once again are concerned about a weak dollar and world tensions.

On a final note, the Treasury market is well on its way to one of its best starts since 2001 following the announcement that the U.S. unemployment was up to its highest rate in over two years. This adds fuel to speculation that the Federal Reserve will cut borrowing costs more than the forecast in order to prevent a recession.

To continue with the more in-depth analysis, please visit www.streetinvesting.com for a complimentary subscription to access this report and other related articles. Please note that membership does not require credit card information.

All material herein was prepared by Streetinvesting.com, (Street Investing) based upon information believed to be reliable. The information contained herein is not guaranteed by Streetinvesting.com to be accurate, and should not be considered to be all-inclusive. The companies that are discussed in this opinion have not approved the statements made in this opinion. This opinion contains forward-looking statements that involve risks and uncertainties. This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Streetinvesting.com is not a licensed broker, broker dealer, market maker, investment banker, investment advisor, analyst or underwriter. Please consult a broker before purchasing or selling any securities viewed on or mentioned herein. Streetinvesting.com may receive compensation in cash or shares from independent third parties or from the companies mentioned.

Streetinvesting.com's affiliates, officers, directors and employees may also have bought or may buy the shares discussed in this opinion and may profit in the event those shares rise in value.

Streetinvesting.com will not advise as to when it decides to sell and does not and will not offer any opinion as to when others should sell; each investor must make that decision based on his or her judgment of the market.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a companies' annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission.

You should consider these factors in evaluating the forward- looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and Streetinvesting.com undertakes no obligation to update such statements.

CONTACT: Streetinvesting.com

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MIB Abstract ID Number: 14364

Proquest Identifier: 1408763741

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NON-HODGKIN LYMPHOMA; Research from Biogen Idec, Inc. yields new findings on non-hodgkin lymphoma

Lead Author: [none given]

Healthcare Mergers, Acquisitions & Ventures Week, 2008-01-05, EXPANDED REPORTING; Pg. 519

lbritumomab tiuxetan radioimmunotherapy produces durable remissions in patients with relapsed/refractory indolent non-Hodgkin lymphoma (see also Non-Hodgkin Lymphoma). The dosing of Yttrium 90 (Y-90)-ibritumomab tiuxetan is based on patient weight and platelet count: 0.4 mCi/kg in patients with a count >= 150 x 1091, to a maximum dose of 32 mCi," scientists in the United States report.

"Patients weighing > 80 kg with platelet counts of ! 150 x 10(9)/L receive a lower dose per unit of body weight. We evaluated whether this influences the safety or efficacy of treatment. Data on efficacy and safety in patients in 3 registration trials who were treated with 90Y ibritumomab tiuxetan at 0.4 mCi/kg (patients weighing ! 80 kg) or 32 mCi (patients weighing > 80 kg) were collected. Clinical responses were evaluated in 103 patients weighing ! 80 kg (median, 70 kg) and 67 patients weighing > 80 kg (median, 95 kg). Sex (41% female vs. 73% male) was the only significantly different characteristic between the patients weighing <= 80 kg and > 80 kg, respectively, The overall response rates were 79% (<= 80 kg) and 70% (> 80 kg), and the complete response rates were 28% and 34%, respectively. Median times to progression were 8.9 months (<= 80 kg) and 9.5 months (> 80 kg). There were no significant differences in efficacy measures or in the incidences of grade 3/4 nonhernatologic adverse events, neutropenia, thrombocytopenia, or anemia," wrote G.A. Wiseman and colleagues, Biogen Idec, Inc.

The researchers concluded: "The dose of 90Y ibritumomab tiuxetan was < 0.4 mCi/kg in 39% of patients, owing to the 32-mCi dose cap, but the efficacy or safety of 90Y ibritumomab tiuxetan in patients > 80 kg was not affected."

Wiseman and colleagues published their study in Clinical Lymphoma & Myeloma (Weight-based dosing of Yttrium 90 ibritumomab tiuxetan in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Clinical Lymphoma & Myeloma, 2007;7(8):514-517).

For additional information, contact K. Vo, Biogen Idec Inc.,5200 Research Pl, San Diego, CA 92122, USA.

 

The publisher's contact information for the journal Clinical Lymphoma & Myeloma is: Cig Media Group, Lp, 3500 Maple Avenue, Ste. 750, Dallas, TX 75219-3931, USA.

MIB Abstract ID Number: 14365

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Rituxan / rituximab & Genentech

High level expression of a functional human/mouse chimeric anti-CD20 monoclonal antibody in milk of transgenic mice.

Lead Author: Tang B

Additional Authors: Yu S, Zheng M, Ding F, Zhao R, Zhao J, Dai Y, Li N.

Transgenic Res. , 2008-01-09, [Epub ahead of print]

State Key Lab for Agrobiotechnology, China Agricultural University, , Yuanmingyuan West Rd. 2, Haidian District, Beijing, 100094, China, ninglcau@cau.edu.cn.

Rituximab, a chimeric anti-CD20 monoclonal antibody, is one of the most successful biomedicines and has been used to treat at least 370,000 patients with indolent, aggressive non-Hodgkin's lymphoma and other malignant diseases. However, the global demand for rituximab and other therapeutic monoclonal antibodies is exponentially increasing and barely able to be met by current manufacturing capacities of mammalian cell culture. The mammary gland bioreactor has been regarded as an ideal substitute for mammalian cell culture to mass-produce recombinant monoclonal antibodies at the lowest possible cost. Here, we show a feasible model to produce recombinant anti-CD20 antibodies in the mammary glands of transgenic animals. Six lines of transgenic mice were generated by co-microinjection of the two expression cassettes that can specially express the chimeric light and heavy chain of anti-CD20 mAbs in the milk of transgenic animals. The recombinant antibodies were detected in the milk of transgenic mice with the highest expression level up to 17 mug/mul and could specifically bind the CD20 surface antigens on human B-lymphoma cells.

MIB Abstract ID Number: 14331

PreMedline Identifier: 18183493

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Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

Lead Author: [none given]

Biotech Week, 2008-01-09, EXPANDED REPORTING; Pg. 2728

Cephalon, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of TREANDA(R) (bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen. According to the National Cancer Institute, an estimated 30,000 people in the United States will be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment.

"TREANDA is the lead product in our oncology pipeline and with this second NDA submission for the product in 2007 we have achieved a significant milestone for our business," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "The clinical data supporting this submission highlight the potential of TREANDA to make a meaningful difference for patients with indolent NHL who have relapsed during or following treatment with rituximab."

The TREANDA NDA for relapsed indolent NHL is supported by three studies in patients with NHL, including one in combination with rituximab. In these studies, patients treated with TREANDA had a high rate of response and a manageable and tolerable side effect profile, with adverse events similar to those observed with other chemotherapy agents.

MIB Abstract ID Number: 14354

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Genmab
Ofatumumab & Genmab
HuMax (CD4, CD32b, CD20) & Genmab

Genmab Announces HuMax-CD32b Pre-Clinical Program; Summary: Genmab has Announced a New Pre-Clinical Antibody Program Called HuMax-CD32b.

Lead Author: [none given]

PR Newswire. New York: , 2008-01-04

COPENHAGEN, January 4 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today a new pre-clinical antibody program called HuMax-CD32b(TM). This fully human IgG1,k antibody targets the CD32b receptor found on immune cells and hematological tumors. HuMax-CD32b may have therapeutic potential in the treatment of B-cell chronic lymphocytic leukemia, small lymphocytic lymphoma, Burkitt's lymphoma, follicular lymphoma and diffuse large B-cell lymphoma.

The lead candidate for HuMax-CD32b was selected from a panel of over 60 antibodies based on its excellent selectivity and binding ability for the CD32b target and potent triggering of the immune system killing mechanism antibody-dependent cellular cytotoxicity (ADCC). The antibody was highly effective in suppressing tumor growth in in vivo mouse tumor models in which tumor growth was monitored by highly sensitive bioluminescence imaging.

In animal models, HuMax-CD32b has been shown to induce impressive anti-tumor responses. The CD32b receptor has an inhibitory role on immune cells and blockade of CD32b has been documented to strongly potentiate the therapeutic effects of other anti-tumor antibodies. An antibody targeting CD32b may thus be attractive for combination therapy with other antibodies.

"We believe HuMax-CD32b has great potential as a cancer therapeutic, both because of its impressive anti-tumor activity, and the potential for combination with other therapeutic antibodies, such as antibodies directed to CD20 or CD38." said Prof. Jan G. J. van de Winkel, Ph.D., Chief Scientific Officer at Genmab A/S.

Contact:

Helle Husted,

Sr. Director,

Investor Relations,

T: +45-33-44-77-30,

M: +45-25-27-47-13,

E: hth@genmab.com

SOURCE Genmab A/S

MIB Abstract ID Number: 14366

Proquest Identifier: 1407397331

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GlaxoSmithKline
Bexxar / tositumomab & GlaxoSmithKline
Hoffmann-La Roche
Ocrelizumab & Hoff.-La Roche
Medicis
Dynacin, Minocin, Vectrin / minocycline & Medicis
Pfizer Pharmaceuticals
Azulfidine / sulfasalazine & Pfizer
Prometheus Laboratories
Imuran / azathioprine & Prometheus
Seattle Genetics
SGN-40 (in Combination with Rituxan) & Seattle Gen.

Genentech begins NHL trial with SGN-40 triggering milestone payment to SG

Lead Author: [none given]

Pharma Agreement News, 2008-01-08

Seattle Genetics ' (SG) collaborator, Genentech , has initiated a Phase Ib trial of SGN-40 in combination with Rituxan (rituximab) for patients with relapsed follicular or marginal zone non-Hodgkin’s lymphoma (NHL). As a result, SG will receive a $4US million milestone payment from Genentech. The study will enrol patients with relapsed follicular or marginal zone NHL at multiple cancer centres in the US.

The trial is designed to assess the safety, pharmacokinetics and preliminary activity of escalating doses of SGN-40 when combined with rituximab. In collaboration with Genentech, SG is conducting a joint development plan for SGN-40 that includes six ongoing or planned clinical trials of SGN-40 both as a single agent and combined with standard therapies for NHL and multiple myeloma. A Phase IIb trial of SGN-40 in combination with R-ICE (Rituxan, ifosfamide, carboplatin and etoposide) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a Phase II single-agent trial in DLBCL and a Phase Ib study of SGN-40 in combination with Revlimid (lenalidomide) in relapsed or refractory multiple myeloma are ongoing. Under the terms of the collaboration agreement, SG received an up-front payment of $60US million in February 2007, and is entitled to receive potential milestone payments exceeding $800US million and escalating double-digit royalties starting in the mid-teens on sales of SGN-40.

MIB Abstract ID Number: 14362

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Seattle Genetics to Present at the 26th Annual JPMorgan Healthcare Conference

Lead Author: [none given]

Business Wire. New York: , 2008-01-04

Seattle Genetics, Inc.

Corporate Communications

Peggy Pinkston, 425-527-4160

ppinkston@seagen.com

Logo: http://www.seattlegenetics.com

Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that Clay B. Siegall, Ph.D., President and Chief Executive Officer, will speak at the 26th Annual JPMorgan Healthcare Conference on Monday, January 7, 2008, at 3:30 p.m. Pacific Time. The conference is being held at the Westin St. Francis Hotel in San Francisco, California. A live webcast of the presentation will be available from Seattle Genetics' website, www.seattlegenetics.com, under the "news and investor information" section.

MIB Abstract ID Number: 14363

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Schering-Plough
Solganal / aurothioglucose & Scher.-Plough
Lymphoma (Non-Hodgkin's)
Anthracycline & Lymphoma
Cluster of Differentiation 20 (CD20) antibody & Lymphoma
Anti CD20 Monoclonals & Lymphoma

Reports from University of Illinois highlight recent research in monoclonal antibodies

Lead Author: [none given]

Drug Law Weekly, 2008-01-08, EXPANDED REPORTING; Pg. 951

In this recently published article, scientists in the United States conducted a study "To assess whether intravitreal rituximab 1 mg/0.1 cc penetrates the retina of Dutch-belted rabbits. Two right eyes of two rabbits were injected with intravitreal rituximab 1 mg/0.1 mL, and one right eye of one rabbit was injected with intravitreal tissue plasminogen activator (tPA) 12.5 mu g/0.1 mL, as a protein control."

"The three left eyes received no intravitreal injections. The rabbits were killed; the eyes were enucleated and immediately frozen at -80 degrees C. Rituximab was detected using rabbit antihuman IgG (whole molecule) peroxidase conjugated antibody. tPA was detected using an antihuman IgG with a sheep antilhuman tPA antibody conjugated with peroxidase. There was staining in all retinal layers of the two eyes injected with intravitreal rituximab, and no staining of the retina in the eye injected with intravitreal tPA. The three control eyes showed no staining in any retinal layer.," wrote J.S. Pulido and colleagues, University of Illinois.

The researchers concluded: "Intravitreal rituximab at a dose of 1 mg/0.1 cc penetrates the retina of Dutch-belted rabbits while the control intravitreal tPA at a dose of 12.5 mu g/0.1 cc does not."

Pulido and colleagues published their study in Retina - the Journal of Retinal and Vitreous Diseases (Rituximab penetrates full-thickness retina in contrast to tissue plasminogen activator control. Retina - the Journal of Retinal and Vitreous Diseases, 2007;27(8):1071-1073).

For additional information, contact D. Shukla, University of Illinois, Dept. of Ophthalmology & Visual Science, 1855 W Taylor St. MC 648, Chicago, IL 60612, USA.

The publisher's contact information for the Retina - the Journal of Retinal and Vitreous Diseases is: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA.

MIB Abstract ID Number: 14361

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CD20 positive, follicular & Lymphoma

Lymphoma; Study data from E. Domingodomenech and co-authors update knowledge of lymphoma

Lead Author: [none given]

Hematology Week. Atlanta:, 2008-01-07, pg. 189

2008 JAN 7 - (NewsRx.com) -- According to a study from Barcelona, Spain, "Background and Objectives Single-nucleotide polymorphisms (SNP) in interleukin-10 (IL-10) genes can influence immune responses, which may affect the outcome of patients with lymphoid neoplasms. The aim of this study was to explore the association between polymorphisms Of IL-10-(1082A >G) and IL-10-(3575T >A) with the overall survival in patients with lymphoid neoplasms."

"Design and Methods We analyzed two IL-10 SNP (-1082 and -3575) in 472 consecutive cases with lymphoid neoplasms. Genotypes were tested for association with overall survival and classical prognostic factors by multivariate analysis. Haplotype analysis was carried out using the haplostats package implemented in R software. The implications for survival of patients with lymphoma were evaluated using multivariate analysis. Results Lymphoma patients with the IL-10-(3575T >A) genotype had a better overall survival (p= 0.002), as did the subgroup with non-Hodgkin's lymphoma (NHL) (p=0.05). Patients with the IL10(1082GG) genotype had a better median overall survival (p=0.05). When both genotypes were included in a multivariate analysis, IL-10-(3575AA) genotype was the only independent prognostic factor for survival (HR=0.20, 95%Cl 0.05- 0.92). Patients with the IL-10-(1082A >G) and -3575 G-A/G-A diplotype had a longer overall survival (p=0.003) and this combination appeared to be an independent prognostic factor for survival (HR:0.26; 95%Cl 0.08-0.83). Interpretation and Conclusions The IL-10-(357BA/A) genotype was identified as a marker of favorable survival. Because the IL-10-(1082) and -3575 G-A/G-A diplotype was also identified as an indicator of longer survival, we cannot exclude the potential additive role of the IL-10-(1082GG) genotype," wrote E. Domingodomenech and colleagues.

The researchers concluded: "These results need to be replicated in larger series and examined in different NHL subtypes."

Domingodomenech and colleagues published the results of their research in Haematologica - the Hematology Journal (Impact of interleukin-10 polymorphisms (-1082 and -3575) on the survival of patients with lymphoid neoplasms. Haematologica - the Hematology Journal, 2007;92(11):1475-1481).

For additional information, contact E. Domingodomenech, Hospital Llobregat, Institute Catala Oncology, Dept. of Hematology, Avda Gran Via S-N, Km 2-7, Barcelona 08907, Spain.

The publisher of the Haematologica - the Hematology Journal can be contacted at: Ferrata Storti Foundation, Via Giuseppe Belli 4, 27100 Pavia, Italy.

MIB Abstract ID Number: 14340

Proquest Identifier: 1407185281

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Lymphoma; Study data from American University of Beirut, Department of Anesthesiology update understanding of lymphoma

Lead Author: [none given]

Stem Cell Week. Atlanta: , 2008-01-07, pg. 43

2008 JAN 7 - (NewsRx.com) -- Investigators publish new data in the report 'Value of pretransplant pulmonary function tests in predicting pulmonary complications after autologous peripheral stem cell transplantation.' According to recent research from Beirut, Lebanon, "The aim of this study was to evaluate the value of pulmonary function tests performed before an autologous peripheral stem cell transplant (APSCT) in identifying patients who are at risk for developing post-transplant pulmonary complications. This retrospective study included patients who underwent autologous peripheral stem cell transplantation from January 1997 to December 2006."

"The total sample consisted of 43 patients with 24 patients (55.8%) having multiple myeloma, 9 patients (20.9%) having Hodgkin's lymphoma, and 10 patients (23.3%) having non-Hodgkin's lymphoma. The patients' average age at the time of diagnosis and at the time of APSCT was 41.8 +-14.6 and 43.1 +-14.2 years, respectively. After APSCT, 8 patients (18.6%) had pulmonary complications all of which were infectious pneumonia. The mean pretransplant forced midexpiratory flow (FEF(25-75%)) in the patients who developed post- transplant pulmonary complications was significantly lower than the mean pretransplant FEF(25-75%) in the patients who did not develop post-transplant pulmonary complications (75.5 +-19.9% vs. 104.3 +- 24.5%, p=0.004). There were no other differences in the pretransplant pulmonary function test parameters between the patients who developed post-transplant pulmonary complications and the patients who did not develop post-transplant pulmonary complications," wrote M. El-Khatib and colleagues, American University of Beirut, Department of Anesthesiology.

The researchers concluded: "Our results showed that patients with decreased pretransplant FEF(25-75%) are at risk for developing pulmonary complications in the post autologous stem cell transplantation period."

El-Khatib and colleagues published their study in Lung (Value of pretransplant pulmonary function tests in predicting pulmonary complications after autologous peripheral stem cell transplantation. Lung, 2007;185(6):321-4).

For additional information, contact M. El-Khatib, American University of Beirut Medical Center, Dept. of Anesthesiology, Beirut, Lebanon.

Publisher contact information for the journal Lung is: Springer, 233 Spring Street, New York, NY 10013, USA.

MIB Abstract ID Number: 14341

Proquest Identifier: 1407225861

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Non-Hodgkin Lymphoma; Researchers from Kyungpook National University, Medical Department describe findings in non-hodgkin lymphoma

Lead Author: [none given]

Stem Cell Week. Atlanta:, 2008-01-07, pg. 25

2008 JAN 7 - (NewsRx.com) -- "The current study aimed to evaluate the efficacy and toxicity of a combination of intravenous busulfan, cyclophosphamide and etoposide (i.v. Bu/Cy/E) as a conditioning regimen prior to autologous hematopoietic stem cell transplantation in patients with non-Hodgkin's lymphoma (NHL)," researchers in South Korea report.

"Sixty-four patients with relapsed/ refractory (n = 36) or high- risk (n = 28) lymphoma were enrolled. The high-dose chemotherapy consisted of i.v. Bu (0.8 mg kg(-1) i.v. q 6h from day -7 to day - 5), Cy (50 mg kg(-1) i.v. on day -3 and day -2) and E (400 mg m(-2) i.v. on day -5 and day -4). The median age was 43 (range 18-65) years, and 39 patients were male. Diffuse large B-cell lymphoma (40.6%) was the most common histological subtype. All evaluable patients achieved an engraftment of neutrophils (median, day 12) and platelets (median, day 13). Hepatic veno-occlusive disease was observed in four patients (three mild, one moderate grade), and two patients (3.1%) died from treatment-related complications. At a median follow-up of 16.4 months, 15 patients (23.4%) exhibited a relapse or progression, while 13 patients (20.3%) had died of disease. The estimated 3-year overall and progression-free survival for all patients was 72.1 and 70.1%, respectively," wrote J.G. Kim and colleagues, Kyungpook National University, Medical Department.

The researchers concluded: "The conditioning regimen of i.v. Bu/ Cy/E was well tolerated and seemed to be effective in patients with aggressive NHL."

Kim and colleagues published their study in Bone Marrow Transplantation (Multicenter study of intravenous busulfan, cyclophosphamide, and etoposide (I.v. Bu/Cy/E) as conditioning regimen for autologous stem cell transplantation in patients with non-Hodgkin's lymphoma. Bone Marrow Transplantation, 2007;40(10):919- 924).

For additional information, contact S.K. Sohn, Kyungpook National University, School Medical, Dept. of Hematology Oncology, Kyungpook National University Hospital, 50 Samduck 2-Ga, Taegu 700721, South Korea.

Publisher contact information for the journal Bone Marrow Transplantation is: Nature Publishing Group, Macmillan Building, 4 Crinan St., London N1 9XW, England.

MIB Abstract ID Number: 14342

Proquest Identifier: 1407225061

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Sun deters cancer risk

Lead Author: [none given]

Townsville Bulletin. Townsville, Qld., 2008-01-05, pg. 18

RECREATIONAL sun exposure could help prevent a type of blood cancer called non-Hodgkin's lymphoma (NHL), a study indicates.

Recreational sun exposure -- defined as hours spent in the sun on non-working days -- between the ages of 18 and 40, reduced the risk of the disease.

Sun exposure could exert its anti-cancer effects by boosting vitamin D production in the skin, the researchers told the International Journal of Cancer.

"If sun exposure does protect against NHL it is an intermittent pattern of sun exposure that is the most protective," Dr Anne Kricker said.

MIB Abstract ID Number: 14345

Proquest Identifier: 1408098911

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Jefferson to study intravenous Vitamin C vs. cancer

Lead Author: Marie McCullough.

McClatchy - Tribune Business News. Washington: , 2008-01-03

Jan. 3--Thomas Jefferson University researchers are conducting a tiny study that they hope will help answer a big question: Is intravenous Vitamin C effective against cancer?

Beginning next week, they will give high-dose intravenous Vitamin C to 20 non-Hodgkin's lymphoma patients who have failed standard treatments and have a life expectancy of less than a year.

Over 10 weeks, the patients will receive 30 infusions, while the scientists watch for tumor shrinkage or other signs that the progression of the immune-system cancer has slowed or stopped.

"We want to see if there are some trends of hopefulness," physician Daniel Monti, director of Jefferson's Myrna Brind Center of Integrative Medicine, said yesterday.

The theory that Vitamin C can treat cancer was championed decades ago by Linus Pauling, the two-time Nobel laureate-turned-Vitamin C zealot. Pointing to his own inconclusive studies, in which some patients experienced seemingly miraculous cancer cures and remissions, he pushed for more research.

In the 1970s, the federal government finally funded two rigorous clinical trials. But cancer patients showed no benefit, and Pauling's theory was discredited.

The flaw in those studies, Monti and his collaborators now believe, was that the patients took Vitamin C orally.

Only by putting ascorbate directly into a vein can blood levels reach concentrations high enough to be toxic to cancer cells.

Over the last decade, this cancer-cell-killing effect has been clearly shown in lab dishes and in animal studies led by Mark Levine, a nutrition researcher at the National Institutes of Health.

"I am very excited about the study at Thomas Jefferson University," Levine, who is among Monti's collaborators, said in an e-mail.

The Jefferson patients will get infusions of up to 100 grams of Vitamin C -- more than 1,500 oranges' worth.

Levine has shown that at that concentration, ascorbate generates hydrogen peroxide, a powerful oxidant used as a bleaching agent and antiseptic. Although toxic to cancer cells, the chemical does not harm healthy cells.

Jefferson, which is underwriting the study, is among a handful of institutions revisiting the Vitamin C debate.

At the University of Kansas Medical Center, physician Jeanne Drisko recently completed a study of intravenous Vitamin C in 30 ovarian-cancer patients; she expects to publish the results this year.

Drisko hopes these small "stepping-stone" studies will persuade the NIH to fund large, new trials. So far, it has said no, even though Levine's work is respected.

"I think what these initial studies will show us is that it's safe," said Drisko, who consulted on the Jefferson study. "I don't think it will be definitive until we have several large, multicenter trials."

The Jefferson researchers are committed to publishing the results -- no matter what they show.

------

The cancer-cure controversy: Pros, cons and links for the claims about Vitamin C: http://go.philly.com/health

Contact staff writer Marie McCullough at 215-854-2720 or mmccullough@phillynews.com.

MIB Abstract ID Number: 14348

Proquest Identifier: 1406710361

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Studies from American Cancer Society in the area of cancer described

Lead Author: [none given]

Aging & Elder Health Week, 2008-01-06, EXPANDED REPORTING; Pg. 42

Data detailed in 'Psychological distress of female cancer caregivers: effects of type of cancer and caregivers' spirituality' have been presented. According to recent research from the United States, "This study examined the effects of the survivor's cancer type (gender-specific vs nongender-specific) and the female caregiver's spirituality and caregiving stress on the caregiver's psychological distress. Cancer caregivers, who were nominated by cancer survivors, participated in a nationwide quality-of-life survey with 252 caregivers providing complete data for the variables."

"Breast and ovarian cancer were categorized as gender-specific types of cancer (GTC+), whereas kidney, lung, non-Hodgkin's lymphoma (NHL), and skin melanoma cancers were GTC-. Spirituality, caregiving stress, and psychological distress were measured using the functional assessment of chronic illness therapy--spiritual well-being, stress overload subscale, and profile of mood states--short form, respectively. Hierarchical regression analyses revealed that female caregivers whose care recipient was diagnosed with a nongender specific type of cancer (GTC-group) reported higher psychological distress than did the GTC+ group. The GTC-group also reported lower spirituality and higher caregiving stress related to higher psychological distress than did the GTC+ group. In addition, the beneficial effect of spirituality on reducing psychological distress was more pronounced among the GTC-group or when caregiving stress increased," wrote Y. Kim and colleagues, American Cancer Society.

The researchers concluded: "Our findings suggest that female caregivers of survivors with a nongender-specific cancer may benefit from programs designed to reduce their psychological distress, and caregivers who are low in spirituality need help to derive faith and meaning in the context of cancer care."

Kim and colleagues published their study in Supportive Care In Cancer (Psychological distress of female cancer caregivers: effects of type of cancer and caregivers' spirituality. Supportive Care In Cancer, 2007;15(12):1367-74).

For additional information, contact Y. Kim, Behavioral Research Center, American Cancer Society, Atlanta 30303 USA..

Publisher contact information for the journal Supportive Care In Cancer is: Springer, 233 Spring Street, New York, NY 10013, USA.

MIB Abstract ID Number: 14356

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Research from Tilburg University provide new insights into non-hodgkin lymphoma quality of care

Lead Author: [none given]

Aging & Elder Health Week, 2008-01-06, EXPANDED REPORTING; Pg. 141

Investigators publish new data in the report 'Health-related quality of life and health care utilisation among older long-term cancer survivors: a population-based study.' According to recent research from Netherlands, "The consequences of cancer and its treatment on health-related quality of life (HRQL) and health care utilisation among elderly long-term cancer survivors have rarely been studied. However, the impact can be different for older compared to younger patients due to the higher prevalence of comorbid diseases, a higher risk of treatment-related complications and because they often receive different therapies compared to younger patients."

"Therefore, this study addressed the following questions; do HRQL and health care utilisation differ between younger and elderly cancer survivors, and are those differences age or disease related. A population-based, cross-sectional survey among 1893 long-term survivors of endometrial cancer, prostate cancer and non-Hodgkin's lymphoma was conducted using a cancer registry. HRQL was measured by the SF-36 and health care utilisation was measured with a self-reported questionnaire. Results were compared to a normative population. Patients with disease progression were excluded resulting in a total number of 1112 patients to be analysed. Young non-Hodgkin lymphoma survivors (<70 years) reported lower vitality, bodily pain and general health compared to the normative population while older (70 years) survivors did not differ from the norm. Young lymphoma survivors experienced better physical functioning compared to older survivors. Young endometrial cancer survivors experienced less bodily pain compared to the normative population while older survivors did not differ from the norm. Young endometrial cancer survivors experienced better physical and role functioning compared to older survivors. Young prostate cancer survivors reported less bodily pain compared to the norm while older survivors did not. Young prostate cancer survivors reported higher scores on physical functioning compared to older survivors. Age, comorbid diseases, educational level and current occupation influenced HRQL significantly. Both younger and older cancer survivors visited their medical specialist, but not their GP, significantly more often compared to the age-matched general Dutch population. Both younger and older cancer survivors only sporadically used additional care services after cancer treatment. HRQL of older and younger survivors is comparable, with the exception of physical functioning which is lower in older survivors. This difference in physical functioning was probably not caused by cancer because physical functioning among cancer survivors did not differ much compared to an age-matched normative population," wrote F. Mols and colleagues, Tilburg University.

The researchers concluded: "Both younger and older long-term cancer survivors visited their medical specialist often but only sporadically used additional care services after cancer treatment."

Mols and colleagues published their study in European Journal of Cancer (Health-related quality of life and health care utilisation among older long-term cancer survivors: a population-based study. European Journal of Cancer, 2007;43(15):2211-21).

For additional information, contact F. Mols, Center of Research on Psychology in Somatic Diseases, Tilburg University, PO Box 90153, 5000 LE Tilburg, Netherlands.

Publisher contact information for the European Journal of Cancer is: Pergamon-Elsevier Science Ltd., the Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, England.

MIB Abstract ID Number: 14358

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Chimeric Monoclonal Antibody (CMA) & Lymphoma

Reports from Xiamen University describe recent advances in lymphoma

Lead Author: [none given]

Biotech Week, 2008-01-09, EXPANDED REPORTING; Pg. 1052

According to recent research from People's Republic of China, "Ig/Ig two-component-determined circulating immune complex (TCIC) may reveal alteration in immune regulation in patients (see also Lymphoma). In the current study, IgM and IgG-TCIC was investigated in sera of patients suffering from esophagus, intestine, lung, nasopharyngeal, ovarian, breast, uterine and thyroid cancers, and hepatocellular carcinoma, Hodgkins lymphoma, non-Hodgkins lymphoma."

"This investigation was performed by detection of IgM/IgG-TCIC and IgG/IgM-TCIC with the use of ELISA by the reciprocal use of coating and detecting antibodies. The current study was carried out in 979 patients with these cancers and 401 healthy controls. We found that down-regulated IgM/IgG-TCIC was a common feature in these patients, whereas levels of IgG/ IgM-TCIC showed significantly higher, lower or no difference with respect to the control. In summary, our results suggest that IgM and IgG-TCIC may play an important role in immune regulation during the course of malignancies and may be a hallmark for cancer pathogenesis. Decreased IgM/IgG-TCIC, accompanied by diverse IgG/IgM-TCIC, forms a peculiar trait in malignancies," wrote T.C. Yang and colleagues, Xiamen University.

The researchers concluded: "Our findings thus provide new insights into immune regulation in patients with malignancies."

Yang and colleagues published their study in International Immunopharmacology (Detection of IgM and IgG complexes provides new insight into immune regulation of patients with malignancies: A randomized controlled trial. International Immunopharmacology, 2007;7(11):1433-1441).

For additional information, contact S.Y. Wang, Xiamen University, School Life Science, Dept. of Biology, Fujian 361005, People's Republic of China.

Publisher contact information for the journal International Immunopharmacology is: Elsevier Science BV, PO Box 211, 1000 AE Amsterdam, Netherlands.

MIB Abstract ID Number: 14351

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Humanized Ocrelizumab & Lymphoma
Humanized Ofatumumab & Lymphoma
Leukemia & Lymphoma

CEBPA polymorphisms and mutations in patients with acute myeloid leukemia, myelodysplastic syndrome, multiple myeloma and non-Hodgkin's lymphoma.

Lead Author: Fuchs O

Additional Authors: Provaznikova D, Kocova M, Kostecka A, Cvekova P, Neuwirtova R, Kobylka P, Cermak J, Brezinova J, Schwarz J, Markova J, Salaj P, Klamova H, Maaloufova J, Lemez P, Novakova L, Benesova K.

Blood Cells Mol Dis. , 2008-01-06, [Epub ahead of print]

Institute of Hematology and Blood Transfusion, Department of Cell Physiology, U Nemocnice 1, 128 20 Prague 2, Czech Republic.

The transcription factor CCAAT/enhancer binding protein (C/EBP)alpha is a myeloid-specific transcription factor which is required for normal myeloid differentiation. C/EBPalpha is encoded by an intronless gene that is 2783 bp long and maps to human chromosome 19q13.1. C/EBPalpha is a member of the basic region leucine zipper (bZIP) class of DNA-binding proteins. The loss of function of C/EBPalpha has leukemogenic potential. Four types of polymorphisms and 25 mutations (3 already known mutations and 22 novel mutations) were detected in CEBPA (gene for the transcription factor CCAAT/enhancer binding protein (C/EBP) alpha) in analysed samples from 390 patients with myelodysplastic syndrome (MDS) and hematologic malignancies. CEBPA mutations were found in 14/152 (9.2%) of acute myeloid leukemia (AML) patients' samples, 6/143 (4.2%) of MDS patients' samples, 2/56 (3.6%) of non-Hodgkin's lymphoma (NHL) patients' samples and 2/39 (5.1%) of multiple myeloma (MM) patients' samples. No C/EBPalpha mutations were detected in healthy donors (41 individuals). We discuss how these mutations can affect the cellular function of C/EBPalpha and block the myeloid differentiation.

MIB Abstract ID Number: 14332

PreMedline Identifier: 18182175

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IgA nephropathy associated with leukemia and lymphoma: report of two cases.

Lead Author: Motoyama O

Additional Authors: Kojima Y, Ohara A, Tsukimoto I, Ishikawa Y, Iitaka K.

Clin Exp Nephrol., 2008-01-05, [Epub ahead of print]

Department of Pediatrics, Toho University Medical Center, Sakura Hospital, 564-1 Shimoshizu, Sakura, Chiba, 285-8741, Japan, motoyan@basil.ocn.ne.jp.

IgA nephropathy (IgAN) associated with leukemia and lymphoma has not, to our knowledge, been reported in children. Two children suffering from these diseases are described here. One patient developed IgAN at the end of 5 years' chemotherapy for acute lymphocytic leukemia. The other had microscopic hematuria 3 years before the onset of non-Hodgkin lymphoma, and hematuria continued during chemotherapy. Each disease occurred after a long interval, and the clinical courses did not run parallel. The association was thought to be incidental in our cases. Chemotherapy with adrenocorticosteroids and immunosuppressants [6-mercaptopurine (6-MP) and cyclophosphamide (CY)] for leukemia and lymphoma did not affect the clinical course of IgAN.

MIB Abstract ID Number: 14335

PreMedline Identifier: 18175050

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Acute Leukemia Therapy; Data on acute leukemia therapy described by researchers at Yokohama City University, Department of Pediatrics

Lead Author: [none given]

Hematology Week. Atlanta: , 2008-01-07, pg. 266

2008 JAN 7 - (NewsRx.com) -- Fresh data on acute leukemia are presented in the report 'Long-term follow-up of busulfan, etoposide, and nimustine hydrochloride (ACNU) or melphalan as conditioning regimens for childhood acute leukemia and lymphoma.' "We retrospectively evaluated early and long-term complications of an intensified conditioning regimen consisting of busulfan and etoposide in combination with either nimustine hydrochloride (ACNU) (BVA regimen, n=18) or melphalan (BVL regimen, n=34) in 52 children with acute leukemia or non-Hodgkin's lymphoma. With a median follow- up of 13.2 years after the BVA regimen and 8.1 years after the BVL regimen, 61% and 76% of patients, respectively, are in continuous complete remission," researchers in Yokohama, Japan report.

"Transplantation-related mortality was 17% and 6% after the BVA and BVL regimens, respectively, and the corresponding relapse rates were 17% and 15%. The most common and severe toxicity was pulmonary complication in the BVA regimen, which was seen in 67% of patients and was life-threatening in 20%. Thirty-three percent of patients after the BVA regimen and 24% after BVL died of relapse or disease progression (n=9), interstitial pneumonia (n=2), fungal pneumonia (n=1), or chronic graft-versus-host disease (n=2). One of the long- term survivors developed secondary leukemia. A significant decrease in the height standard deviation score of more than 2 SD from diagnosis to the last follow-up was seen in 17% of the patients, with hypothyroidism in 15%, and alopecia in 42%. Because our experience is limited to a small heterogeneous population of patients who mainly underwent transplantation in the first remission, we cannot draw conclusions on the treatment's effectiveness. The BVL regimen is tolerable, however, because no regimen-related death was observed, whereas the BVA regimen is not recommended because of the high incidence of pulmonary complications," wrote S. Izaki and colleagues, Yokohama City University, Department of Pediatrics.

The researchers concluded: "The effectiveness of the BVL regimen requires further study."

Izaki and colleagues published their study in International Journal of Hematology (Long-term follow-up of busulfan, etoposide, and nimustine hydrochloride (ACNU) or melphalan as conditioning regimens for childhood acute leukemia and lymphoma. International Journal of Hematology, 2007;86(3):253-60).

For additional information, contact S. Izaki, Yokohama City University School of Medicine, Dept. of Pediatrics, Yokohama, Japan.

Publisher contact information for the International Journal of Hematology is: Carden Jennings Publ Co. Ltd., Blake Center, Ste. 200, 1224 W Main St., Charlottesville, VA 22903, USA.

MIB Abstract ID Number: 14339

Proquest Identifier: 1407186351

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Neoplastic Disease & Lymphoma

Leukemia Presenting as Solid Tumors: Report of Four Pediatric Cases and Review of the Literature.

Lead Author: Urs L

Additional Authors: Stevens L, Kahwash S.

Pediatr Dev Pathol. , 2008-01-07, 1 [Epub ahead of print]

Leukemias are neoplasms that arise from the hematopoetic cells of bone marrow and usually spread first to peripheral blood. Involvement of extramedullary tissue during the course of a leukemia is common and usually does not represent a major diagnostic challenge when the history is available and specimen triage is optimal. In the context of a myeloid origin, extramedullary leukemias are referred to as granulocytic sarcoma, extramedullary myeloid tumor, extramedullary leukemia, or myeloid sarcoma. In the lymphoid category, leukemia involvement of tissue is conventionally distinguished from lymphoma by establishing the presence of 20% or more blasts in the bone marrow. A leukemia with an initial presentation outside the bone marrow mimicking a solid tumor is a rare but well documented clinical encounter. Diagnostic difficulties may arise, especially when a specimen is not triaged properly due to the clinical presumption of a non-hematopoietic tumor. Systematic handling and proper triaging of biopsies are the keys to reducing diagnostic error and facilitating a timely diagnosis in this category. We report four case examples in the pediatric population, presenting in different anatomic sites. The value of fresh specimens and performing touch imprints is discussed and emphasized. Key words Children, extramedullary leukemia, touch imprints.

MIB Abstract ID Number: 14336

PreMedline Identifier: 18179285

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Tumor Reduction & Lymphoma

Frequent microsatellite instability in non-Hodgkin lymphomas irresponsive to chemotherapy.

Lead Author: Miyashita K

Additional Authors: Fujii K, Yamada Y, Hattori H, Taguchi K, Yamanaka T, Yoshida MA, Okamura J, Oda S, Muta K, Nawata H, Takayanagi R, Uike N.

Leuk Res. , 2008-01-03, [Epub ahead of print]

Institute for Clinical Research, National Kyushu Cancer Center, 3-1-1 Notame, Fukuoka 811-1395, Japan; Department of Hematology, National Kyushu Cancer Center, Fukuoka 811-1395, Japan; Department of Medicine and Bioregulatory Science, Graduate School of M

Microsatellite instability (MSI) in haematopoietic malignancies has been controversial. Particularly in non-Hodgkin lymphoma, the data published to date lack unity. Using a unique fluorescent technique, we found MSI in eight (14%) tumours in a panel of 59 carefully selected non-Hodgkin lymphoma patients. Our fluorescent technique also reveals two qualitatively distinct modes of MSI, i.e. Type A and Type B. Based on our previous studies using DNA mismatch repair (MMR) gene-knock out animals, we have concluded that Type A MSI is a direct consequence of defective MMR. MSI observed in non-Hodgkin lymphomas was uniformly Type A, which implies that MMR deficiency occurs in this malignancy. Intriguingly, in non-Hodgkin lymphoma patients treated by CHOP/VEPA-based therapies, response to chemotherapy was significantly worse in those with microsatellite-unstable tumours (p=0.027). As a consequence, the patient outcomes at 1 year after treatment were significantly less favourable in this population (p=0.046), although the survival difference was not statistically confirmed in a longer term. These findings suggest that in some non-Hodgkin lymphomas MMR deficiency may lead to drug resistance in tumour cells and, consequently, to poor patient outcomes. In non-Hodgkin lymphoma, MSI may be a potential biomarker that predicts the tumour response against chemotherapy.

MIB Abstract ID Number: 14334

PreMedline Identifier: 18177936

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non-Hodgkin's lymphoma
B cell & non-Hodgkin's lymphoma

Non-Hodgkin lymphoma related to hereditary nonpolyposis colorectal cancer in a patient with a novel heterozygous complex deletion in the MSH2 gene.

Lead Author: Pineda M

Additional Authors: Castellsagué E, Musulén E, Llort G, Frebourg T, Baert-Desurmont S, González S, Capellá G, Blanco I.

Genes Chromosomes Cancer. , 2008-01-07, [Epub ahead of print]

Translational Research Laboratory, IDIBELL‐ Institut Català d'Oncologia, Barcelona, Spain.

Hereditary nonpolyposis colorectal cancer (HNPCC) is an autosomal disorder caused by mutations in DNA mismatch repair (MMR) genes. Tumors of the HNPCC-spectrum are associated with microsatellite instability (MSI) and loss of MMR protein expression. Lymphomas are not considered to be HNPCC-related tumors. We report and analyze a case of an HNPCC patient with three colorectal cancers and a B-cell non-Hodgkin lymphoma. Quantitative multiplex PCR of short fluorescent fragments detected a novel MSH2 rearrangement involving exons 9 and 10, which proved to be the pathogenic cause of the disease in the family. Tumor tissues including the lymphoma showed MSI and loss of MSH2 expression. Multiplex ligation-dependent probe amplification analysis revealed a somatic loss of the wild-type MSH2 allele in the lymphoma. These results support the fact that the total loss of a MMR gene can lead to lymphomagenesis, as seen in biallelic MMR-deficient families and knockout mice. Moreover, this is the first report of a B-cell non-Hodgkin lymphoma with a loss of the MSH2 protein expression, linked to a heterozygous germline MSH2 mutation in an HNPCC family. (c) 2008 Wiley-Liss, Inc.

MIB Abstract ID Number: 14333

PreMedline Identifier: 18181177

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B-cell identity--commitment is not forever.

Lead Author: Nutt SL.

N Engl J Med. , 2008-01-03, 358(1):82-3.

Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia.

<<no abstract available>>

MIB Abstract ID Number: 14337

PreMedline Identifier: 18172181

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Cancer; Studies from National Cancer Institute reveal new findings on cancer

Lead Author: [none given]

Clinical Oncology Week. Atlanta: , 2008-01-07, pg. 128

2008 JAN 7 - (NewsRx.com) -- "Malathion is the most common organophosphate insecticide applied in the United States, and while some studies suggest that it may be clastogenic, its carcinogenicity has not been demonstrated in rodents. However, malathion has been associated with non-Hodgkin's lymphoma in several epidemiologic studies," scientists in the United States report.

"The authors investigated associations between malathion exposure and cancer among 19,717 pesticide applicators enrolled in the Agricultural Health Study between 1993 and 1997. Information on lifetime years and days per year of use and intensity of malathion exposure was obtained with self-administered questionnaires prior to the onset of any cancer. The average follow-up time was 7.5 years (1993-2002). Rate ratios and 95% confidence intervals were calculated using Poisson regression, adjusting for potential confounders. Overall, lifetime days of malathion use (top tertile of exposure, >39 days) was not associated with all cancers combined (rate ratio = 0.97, 95% confidence interval: 0.81, 1.15). The risk of non-Hodgkin's lymphoma was not associated with malathion use, although the number of cases was small. The risk of melanoma with more than 39 lifetime exposure-days was 0.39 (95% confidence interval: 0.14, 1.03). In summary, malathion exposure was not clearly associated with cancer at any of the sites examined," wrote M.R. Bonner and colleagues, National Cancer Institute.

The researchers concluded: "Although the rate ratios for melanoma were reduced, small numbers and lack of experimental evidence suggest that the observed reductions may have arisen by chance."

Bonner and colleagues published their study in American Journal of Epidemiology (Malathion exposure and the incidence of cancer in the agricultural health study. American Journal of Epidemiology, 2007;166(9):1023-1034).

For additional information, contact M.C.R. Alavanja, National Cancer Institute, Division Cancer Epidemiology & Genetics, 2160 Executive Blvd., Bethesda, MD, USA.

The publisher's contact information for the American Journal of Epidemiology is: Oxford University Press Inc., Journals Dept., 2001 Evans Rd., Cary, NC 27513, USA.

MIB Abstract ID Number: 14338

Proquest Identifier: 1407117271

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Cancer; Kiadis Pharma Reports Successful End of Phase II Meeting With FDA for Reviroc

Lead Author: [none given]

Blood Weekly. Atlanta:, 2008-01-03, pg. 559

2008 JAN 3 - (NewsRx.com) -- Kiadis Pharma announced that it has successfully completed an End of Phase II meeting for Reviroc with the U.S. Food and Drug Administration (FDA). Reviroc is under development for elimination of cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients. The FDA agreed that the data from the completed phase II clinical Reviroc trial is sufficient to support the start of a phase III study. The FDA offered Kiadis Pharma its Special Protocol Assessment (SPA) procedure allowing Kiadis Pharma to work directly with the FDA to optimize the clinical design of the trial.

The FDA meeting followed the successful completion of a multi centre phase II study for Reviroc showing an improved overall survival after autologous bone marrow transplantation in Non- Hodgkin's lymphoma patients. The phase III clinical trial design for Reviroc will focus on patients with Large B cell lymphoma. Kiadis Pharma anticipates filing of the IND, SPA request and Orphan Drug Designation application with the FDA within the next few weeks.

"We are very pleased with the outcome of the End of Phase II meeting with the FDA and with the possibility to access the FDA's Special Protocol Assessment program. Together with the strong support by our principal investigators we are well prepared to design a clear path towards marketing authorization for Reviroc," said Manja Bouman, CEO Kiadis Pharma.

MIB Abstract ID Number: 14346

Proquest Identifier: 1404157141

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Immunotherapy; Genitope Corporation Reports Initial Results of Phase 3 Clinical Trial of MyVax(R) Personalized Immunotherapy

Lead Author: [none given]

Blood Weekly. Atlanta: , 2008-01-03, pg. 577

2008 JAN 3 - (NewsRx.com) -- Genitope Corporation (NASDAQ: GTOP) announced that its pivotal Phase 3 clinical trial examining the use of MyVax(R) personalized immunotherapy in previously untreated follicular B-cell non-Hodgkin's lymphoma (fNHL) patients did not meet its primary endpoint. In the primary analysis, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax(R) personalized immunotherapy compared to patients receiving the control substance. Importantly, analysis of a pre-specified endpoint in the MyVax(R) personalized immunotherapy arm showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not.

In this pivotal, double-blind, randomized, controlled clinical trial, patients first received chemotherapy to reduce their tumor burden, followed by a 6-month rest period. Patients who maintained at least a partial response through the rest period were then randomized to the MyVax(R) personalized immunotherapy or control arm in a 2:1 ratio. Patients who received MyVax(R) personalized immunotherapy received a patient- and tumor-specific idiotype protein conjugated to a foreign carrier protein called keyhole- limpet hemocyanin (KLH). Patients in the control arm received a non- specific immunotherapy consisting only of KLH. Patients in both arms received granulocyte macrophage-colony stimulating factor (GM-CSF) as an immunologic adjuvant at each immunization.

"We are excited by these results because the data clearly show that MyVax personalized immunotherapy is a safe and active drug for follicular lymphoma patients. Both arms of the trial appear to show activity. Patients who received MyVax personalized immunotherapy and mounted a positive immune response to the tumor-specific target demonstrated superior clinical outcomes compared to patients who did not mount this specific immune response. While we recognize that the regulatory path would be clearer had the trial met its primary endpoint, we are pleased with the outcome of the trial. We are working closely with the FDA to determine the path forward for MyVax personalized immunotherapy," said Dan W. Denney, Jr., Ph.D., chairman and chief executive officer of Genitope Corporation.

As previously announced, Genitope Corporation will hold a conference call today at 2 p.m. Pacific/5 p.m. Eastern. The dial-in number for U.S. and Canada is (866) 314-4865 (passcode: 95561171). The international dial-in is (617) 213-8050 (passcode: 95561171). The call can also be accessed in a listen-only mode on Genitope Corporation's website at www.genitope.com. The webcast will be archived for 30 days.

MIB Abstract ID Number: 14347

Proquest Identifier: 1404157491

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New B-cell lymphoma study findings have been reported by investigators at Research Center

Lead Author: [none given]

Biotech Week, 2008-01-09, EXPANDED REPORTING; Pg. 369

"Diffuse large B cell lymphoma (DLBCL) is one of the most common non-Hodgkin's lymphoma types (see also B-Cell Lymphoma). Methylenetetrahydrofolate reductase (MTHFR) balances the pool of folate coenzymes in one carbon metabolism of deoxyribonucleic acid (DNA) synthesis and methylation; both are implicated in carcinogenesis of many types of cancer including lymphoma," scientists writing in the journal Annals of Hematology report.

"Two common variants in the MTHFR gene (C677T and A1298C) have been associated with reduced enzyme activity, thereby making MTHFR polymorphisms a potential candidate as a cancer-predisposing factor. The O(6)p methylguanine DNA methyltransferase (MGMT) and fragile histidine triad (FHIT) genes are transcriptionally silenced by promoter hypermethylation in DLBCL. These genetic differences are highly race specific and have never been screened in the Saudi DLBCL patients. We conducted a hospital-based case-control study including 160 DLBCL cases and 511 Saudi control samples analyzing the MTHFR C677T and A1298C functional polymorphisms by the restriction fragment length polymorphism method and their association with MGMT and FHIT genes promoter hypermethylation. Our data demonstrated that Saudi individuals carrying MTHFR genotype 1298CC (p <0.001) and the 1298C allele (p=0.012) had 4.23 and 1.73-fold higher risk of developing DLBCL, respectively. Additionally, combined genotype CCCC (MTHFR 677CC+MTHFR 1298CC) was associated with 3.489-fold, and CTCC (MTHFR 677 CT+1298CC) was related to 9.515-fold higher risk, compared with full MTHFR enzyme activity. No significant association between MTHFR variant genotypes and methylation of MGMT and FHIT genes were observed. Our findings suggested that polymorphisms of MTHFR enzyme genes might be associated with the individual susceptibility to develop DLBCL," wrote A.K. Siraj and colleagues, Research Center.

The researchers concluded: "Additionally, the results indicated that MTHFR variants were not related to MGMT or FHIT hypermethylation in DLBCL."

Siraj and colleagues published their study in Annals of Hematology (Genetic polymorphisms of methylenetetrahydrofolate reductase and promoter methylation of MGMT and FHIT genes in diffuse large B cell lymphoma risk in Middle East. Annals of Hematology, 2007;86(12):887-895).

Additional information can be obtained by contacting A.K. Siraj, King Faisal Specialist Hospital & Research Center, King Fahd National Center Childerns Cancer & Research, Dept. of Human Cancer Genom Research, Riyadh 11211, Saudi Arabia.

The publisher of the journal Annals of Hematology can be contacted at: Springer, 233 Spring Street, New York, NY 10013, USA.

MIB Abstract ID Number: 14349

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downregulat* & B cell
CD20 & B cell
Tumor Reduction & B cell
Relapsed Follicular & non-Hodgkin's lymphoma

Investigators at Cleveland Clinic have published new data on follicular lymphoma

Lead Author: [none given]

Biotech Week, 2008-01-09, EXPANDED REPORTING; Pg. 773

According to recent research from the United States, "Autologous stem-cell transplantation (ASCT) has been used in follicular lymphoma (FL) to achieve durable responses in first remission or in the relapsed or refractory settings (see also Follicular Lymphoma). Addition of rituximab to chemotherapy for FL has been shown to improve survival."

"The impact of prior therapy with rituximab upon the effectiveness of high-dose therapy (HDT) and ASCT in patients with FL is unknown. We retrospectively reviewed consecutive patients with FL who underwent HDT and ASCT. Patients were categorized according to prior therapy with rituximab. Outcomes were compared between groups in all patients and in a well-matched subset. In all 35 patients received prior rituximab and 71 rituximab-naive patients were analyzed. The rituximab-naive group had a median overall survival (OS) that was not reached during follow-up, with a median relapse-free (RFS) survival of 49.9 months. The prior rituximab group also did not reach median OS and had a median RFS of 24.6 months. Survivals were not significantly different in this group or in the well-matched subset," wrote T.Y. Kang and colleagues, Cleveland Clinic.

The researchers concluded: "These results suggest that the use of rituximab-based regimens for the treatment of FL does not compromise the effectiveness of HDT and ASCT as a salvage strategy in patients with FL."

Kang and colleagues published their study in Bone Marrow Transplantation (Effect of prior rituximab on high-dose therapy and autologous stem cell transplantation in follicular lymphoma. Bone Marrow Transplantation, 2007;40(10):973-978).

For additional information, contact T.Y. Kang, Cleveland Clinic, Taussig Cancer Center, 9500 Euclid Avenue, R35, Cleveland, OH 44195, USA.

Publisher contact information for the journal Bone Marrow Transplantation is: Nature Publishing Group, Macmillan Building, 4 Crinan St., London N1 9XW, England.

MIB Abstract ID Number: 14350

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MethylGene/Pharmion start Phase II trial of MGCD0103 in combination with Vidaza

Lead Author: [none given]

Cancer Drug News, 2008-01-09

The first patient has been enrolled in a Phase II study (Trial 012) evaluating MethylGene / Pharmion 's MGCD0103 , the companies' isotype-selective histone deacetylase inhibitor product candidate, in combination with Vidaza (azacitidine for injection), Pharmion's DNA demethylating agent, in patients with relapsed or refractory Hodgkin's lymphoma or non-Hodgkin's lymphoma. In the trial, patients will receive azacitidine 75mg/m 2 either intravenously or subcutaneously in combination with an oral dose of MGCD0103 in 28-day cycles. Key objectives for this study are to determine the overall response rate, progression-free survival and duration of response. The trial will enrol up to 75 patients at cancer centres in North America and will include a pharmacokinetic equivalency study.

MIB Abstract ID Number: 14355

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Marginal Zone & non-Hodgkin's lymphoma
 
 

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