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• Amgen (4)
• BioCryst (1)
• Forodesine (1)
• Cell Therapeutics (2)
• antiCD20
• Trisenox (arsenic trioxide) (2)
• Dendreon (1)
• Provenge (sipuleucel-T)
• Fred Hutchinson Cancer Research
• Genentech (1)
• Rituxan / Rituximab (1)
• Genta
• Genasense (oblimersen sodium)
• Genzyme / Bayer (1)
• Campath / Alemtuzumab
• Hoffmann-La Roche (1)
• Vesanoid / tretinoin (all-trans retinoic acid or ATRA)
• Novartis Oncology
• Gleevec / Imatinib Mesylate / STI571
• Trubion Pharma
• TRU-016
• Wyeth-Ayerst Pharmaceuticals
• Mylotarg (gemtuzamab ozogamicin) (3)
• Zymogenetics (1)
• IL-21
• TACI-Ig
• Chronic Lymphocytic Leukemia
• chemotherapy (2)
• Philadelphia chromosome
• immunotherapy (3)
• bio* therapy
• Chromosome (3)
• Remission (2)
• Relapse
• Neulasta or Neupogen (Amgen Breast Cancer Drug Possibly Causing Leukemia)
• monoclonal antibody

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Best Practices, Llc; Launch Drugs that Outperform the Competition

Lead Author: [none given]

Biotech Business Week. Atlanta:, 2008-03-03, pg. 1980

2008 MAR 3 - (NewsRx.com) -- As industry projections for 2008 do not show an abundance of new blockbuster brand drugs hitting the market this year, it is even more critical for pharmaceutical companies to have stellar launch plans in place.

Research by biopharmaceutical\benchmarking leader Best Practices, LLC, has found that best-in-class firms focus more marketing resources on the early stages of development in an effort to have a clearer picture of the marketplace.

"Companies need a clear game plan long before they start to put a launch plan into place," said Cameron Tew, senior manager of research and publishing at Best Practices, LLC. "That is why early marketing insights are so critical. These insights allow product teams to achieved faster and higher sales uptake by ensuring that new products get appropriate resources committed at the right time."

The 169-page report, "Launching Pharmaceutical Megabrands: Best Practices in Marketing Blockbusters," includes 96 best practices drawn from surveys and interviews with 24 executives at more than 15 leading pharmaceutical and biotechnology companies such as Pfizer, Merck, Sanofi-Aventis, GlaxoSmithKline, Eli Lilly, Amgen, Boehringer- Ingelheim and Novartis.

For a complimentary download of a study excerpt, visit http:// www3.best-in-class.com/rr911.htm .

Marketing and branding decision-makers can use the report to gather insights on development topics ranging from marketing investment and expense patterns to thought leader development for high-potential products. In addition, the report includes marketing success stories for 16 of the world's top selling drugs.

MIB Abstract ID Number: 14600

Proquest Identifier: 1436347751

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Amgen Shares Sink After Judge Leaves Open The Possibility Of Competition

Lead Author: [none given]

FinancialWire., 2008-03-02, Pg. 1

FinancialWire-March 2, 2008-Amgen Shares Sink After Judge Leaves Open The Possibility Of Competition (C)2008 Investrend Communications, Inc.

March 3, 2008 (FinancialWire) U.S. District Judge William Young has tentatively barred sales of Roche Holding AG s launch of a generic version of Amgen Inc. s (NASDAQ: AMGN) anemia drug, sending its shares to a new-year low before recovering during the regular trading session of Friday.

Judge Young said he was open to allowing U.S. sales of the drug Mircera if Roche agrees to certain conditions, including paying a higher royalty to Amgen. Roche would also have to guarantee it would not charge higher prices than those for Amgen's anemia treatments, Aranesp and Epogen.

Still, Wall Street mostly reaffirmed a positive outlook for Amgen, expecting the company to win the patent dispute. Amgen shares fell one cent to end at $45.52. Earlier in the day, shares of Amgen fell to a 52-week low of $43.72.

For up-to-the-minute news, features and links click on http:// www.FinancialWire.net

FinancialWire is an independent, proprietary news service of Investrend Information, a division of Investrend Communications, Inc. It is not a press release service and receives no compensation from any company for its news or opinions. Other divisions of Investrend, however, provide shareholder empowerment platforms such as forums, independent research and webcasting. For more information or to receive the FirstAlert daily summary of news, commentary, research reports, webcasts, events and conference calls, click on http://www.investrend.com/contact.asp

For a free annual report on a company mentioned in the news, please click on http://investrend.ar.wilink.com/?level=279

To become an investor monitor of independent research for a company in which you are invested, go to the not-for-profit Shareholders Research Alliance, Inc. website by clicking on http:// www.shareholdersresearch.com/

The FinancialWire NewsFeed is now available in multiple formats to your site or desktop, free. Click on: http://www.investrend.com/ XmlFeeds?level=268

MIB Abstract ID Number: 14601

Proquest Identifier: 1437645881

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GRRL Tech Expo Promotes Careers in Science and Technology for 400 R.I. High School Girls

Lead Author: [none given]

Business Wire. New York:, 2008-02-28

Roger Williams University teams up with Tech Collective, Raytheon and other businesses for interactive technology expo

Lt. Gov. Elizabeth Roberts to deliver keynote address

Roger Williams University

Jennifer Sullivan, 401-254-3805

jsullivan@rwu.edu

Cell: 817-657-9176

or

Tech Collective

JoAnn Johnson, 401-521-7805 x 103

jjohnson@tech-collective.org

Cell: 401-447-6957

or

Raytheon Integrated Defense Systems

Carolyn Beaudry, 401-842-3550

Carolyn_Beaudry@raytheon.com

Cell: 401-339-6280

Logo: http://www.tech-collective.org

Tech Collective

WHEN: Friday, March 7

9 a.m. - 1 p.m.

WHERE: Roger Williams University

One Old Ferry Road, Bristol, R.I.

The seventh annual GRRL Tech, an interactive technology expo designed for sophomore and junior high school girls and their teachers, will be held at Roger Williams University on Friday, March 7.

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

MIB Abstract ID Number: 14602

Proquest Identifier: 1436727131

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Anemia drugs up death risk in cancer patients-study

Lead Author: [none given]

Turkish Daily News. (National ed.). Ankara: , 2008-02-28, pg. 1

Treating cancer patients with anemia drugs increases their risk of blood clots and death, U.S. researchers said on Tuesday, confirming concerns about these widely used drugs.

Researchers said the drugs, including Amgen Inc's Aranesp and Johnson & Johnson's Procrit, raised the risk of death by 10 percent in patients who took them, a finding that could not be explained by the higher blood clot risk alone.

"Our findings, in conjunction with basic science studies, raise the concern that the drug may be stimulating cancer and shortening cancer patients' survival," Dr. Charles Bennett of Northwestern University in Chicago said in a statement.

The study, which appears in the Journal of the American Medical Association, sent shares of both companies lower in extended-hours trading on Monday.

"The findings of mortality are new and are different from prior reports," Bennett said in a telephone interview. He said the drugs, erythropoiesis-stimulating agents (ESAs), also increased the risk of blood clots in the lungs and legs by 57 percent in cancer patients, confirming other findings.

An advisory panel to the U.S. Food and Drug Administration is due to discuss safety concerns about the drugs on March 13.

Eric Snyder, an analyst at Mehta Partners, said most investors expected the FDA panel meeting to result in tighter restrictions on the use of anemia drugs.

Worldwide sales of Aranesp fell 12 percent to $3.6 billion in 2007 compared with 2006, while sales of Procrit fell 9.4 percent to $2.9 billion over the same period.

Last March, the FDA warned of an increased risk of serious and life-threatening side effects in a public health advisory on ESAs. And last fall, the U.S. Centers for Medicare and Medicaid Services tightened its reimbursement policy for elderly cancer patients on ESAs.

The drugs generated up to $6 billion in cancer-anemia related sales last year for drug companies and represented Medicare's largest drug expenditure, Bennett said.

Anemia is a common complication of cancer treatment. Millions of cancer and kidney disease patients take ESAs, man-made versions of a human hormone that stimulate production of oxygen-carrying red blood cells.

Amgen spokeswoman Ashleigh Koss said the study does not define any new risks associated with ESAs, and the blood clot risk is included in current labeling.

She said doctors and patients need to weigh the drugs' benefit (avoiding a blood transfusion) and risks and use them appropriately.

J&J said in a statement the study's conclusions "do not provide an accurate reflection of the safety profile" of ESAs when used to treat chemotherapy-induced anemia.

"When used according to product labeling, ESAs remain safe and effective and are the only proven treatment alternative to blood transfusions for patients with chemotherapy-induced anemia," the company said.

Known as a meta-analysis, the study culled data from 51 clinical trials with 13,611 patients treated with ESAs or a placebo. It updates a 2006 report from the Cochrane Collaboration, which studies health-care issues, with additional data on 5,000 patients from 13 clinical trials, many of which addressed the issue of survival. The 2006 report did not show an increased risk of death.

The study is an update of a presentation Bennett made to the American Society of Clinical Oncology in June and includes data through January 17, 2008.

The drugs were approved by the FDA as a treatment for anemic cancer patients to avoid blood transfusions.

"The current FDA recommendation is these drugs are safe for cancer patients as long their hemoglobin levels aren't raised too high. Our data do not support that," Bennett said in a statement.

Dr. Michael Henke of the University of Freiburg, Germany, who worked on the latest analysis, said the study would likely affect treatment guidelines, and that more research was needed to understand the effects of the drugs on cancer patients.

"We suspect that ESAs activate survival pathways in cancer cells," Henke said.

J&J's shares fell 1.5 percent to $62.76 in after-hours trading, while shares of Amgen fell 1.9 percent to $46.90.

MIB Abstract ID Number: 14603

Proquest Identifier: 1436661061

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BioCryst Pharmaceuticals to Announce Fourth Quarter and Fiscal Year 2007 Financial Results on March 4, 2008

Lead Author: [none given]

PR Newswire, 2008-02-28

BIRMINGHAM, Ala., Feb. 28 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals (Nasdaq: BCRX) today announced that its fourth quarter and fiscal year 2007 financial results will be released on Tuesday, March 4, 2008. At 8:30 a.m. Eastern Time BioCryst will host a conference call and webcast to discuss the financial results and provide an update on the Company's programs and further clinical data. The call will be led by Jon P. Stonehouse, BioCryst's Chief Executive Officer, and Stuart Grant, BioCryst's Chief Financial Officer.

The webcast can be accessed by logging onto http://www.biocryst.com. Please connect to the website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. To participate in the conference call, please dial 1-800-860-2442 (U.S.) or 1-412-858-4600 (international). The audio portion of the webcast will be archived and available for replay for 14 days.

MIB Abstract ID Number: 14605

Proquest Identifier: 1436400671

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Azetidine based transition state analogue inhibitors of N-ribosyl hydrolases and phosphorylases.

Lead Author: Evans GB

Additional Authors: Furneaux RH, Greatrex B, Murkin AS, Schramm VL, Tyler PC.

J Med Chem. 2008 Feb 28;, 2008-02-28, 51(4):948-56. Epub 2008 Feb 6.

g.evans@irl.cri.nz.

N-Ribosyl phosphorylases and hydrolases catalyze nucleophilic displacement reactions by migration of the cationic ribooxacarbenium carbon from the fixed purine to phosphate and water nucleophiles, respectively. As the lysis reaction progresses along the reaction coordinate, the distance between the purine and carbocation increases and the distance between carbocation and nucleophile decreases. Immucillin-H and DADMe-immucillin-H have been shown previously to be potent inhibitors of purine nucleoside phosphorylases and lie more toward the reactant and products side of this reaction coordinate, respectively. Both these enzyme inhibitors, which are currently in human clinical trials for different indications, are chiral and expensive to manufacture. We now report the synthesis of azetidine analogues of the DADMe-immucillins, which, despite their lack of stereochemical complexity, remain potent inhibitors (equilibrium dissociation constants as low as 229 pM) of purine nucleoside phosphorylase (PNP), methylthioadenosine phosphorylase (MTAP), and methylthioadenosine nucleosidase (MTAN), with potential utility as drug candidates.

MIB Abstract ID Number: 14606

PreMedline Identifier: 18251493

*To access this PubMed use the PreMedline Identifier in the PubMed search field

Biotechnology Business; Cell Therapeutics, Inc. (CTI) Announces Cancellation of Approximately $9.1 Million of Existing Notes due 2008

Lead Author: [none given]

Biotech Week. Atlanta: , 2008-02-27, pg. 3310

2008 FEB 27 - (NewsRx.com) -- Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq: CTIC; MTAX) announced that it exchanged $8.943 million in aggregate principal of its outstanding 5.75% Convertible Senior Subordinated Notes due 2008 (the "Senior Subordinated Notes") and approximately $150,000 in aggregate principal of its outstanding 5.75% Convertible Subordinated Notes due 2008 (the "Subordinated Notes," and together with the Senior Subordinated Notes, the "Notes"), together with the accrued and unpaid interest on the Notes, for approximately 6.85 million shares of the Company's common stock, no par value (the "Common Stock"). The Common Stock was issued in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). Approximately $10.7 million in Senior Subordinated Notes and Subordinated Notes remain outstanding and mature in June 2008.

The Common Stock to be issued pursuant to the exchange agreement has not been registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state laws.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

MIB Abstract ID Number: 14607

Proquest Identifier: 1432715981

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Biotechnology Business; Cell Therapeutics, Inc. (CTI) Projects Zevalin(R) Sales of $15 Million With Cash Flow Breakeven for Commercial Operations in 2008

Lead Author: [none given]

Biotech Week. Atlanta: , 2008-02-27, pg. 3311

2008 FEB 27 - (NewsRx.com) -- BIO CEO & Investor conference -- James A. Bianco, M.D., President and CEO of Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) will present an overview of the Company's sales and marketing strategy intended to grow Zevalin(R) (Ibritumomab Tiuxetan) sales above the $15 million sales figure reported for 2007. CTI completed the acquisition of Zevalin from Biogen Idec at the end of 2007.

"It is encouraging to see Zevalin U.S. sales stay steady throughout 2007 when compared to 2006 levels considering the lack of any substantial sales, marketing, or medical information effort by its prior owner on behalf of the product in 2007. We believe this steady sales figure provides a stable base from which our commercial group can grow sales for Zevalin's currently approved use in relapsed or refractory follicular non-Hodgkin's lymphoma, a market of more than 10,000 patients in the Unites States," noted Bianco.

"With new compelling clinical data, coupled with our focus on making Zevalin radioimmunotherapy readily available for medical oncologists to administer to patients in their clinics, we believe a significantly higher response rate is achievable with Zevalin over rituximab for relapsed or refractory follicular lymphoma patients following initial therapy and that such results will help grow market share from the current estimated eight percent. This is a very exciting opportunity for CTI and we expect to maximize on this product opportunity for patients and for our shareholders," Bianco continued.

MIB Abstract ID Number: 14608

Proquest Identifier: 1432716001

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Acute promyelocytic leukemia: from highly fatal to highly curable.

Lead Author: Wang ZY

Additional Authors: Chen Z.

Blood., 2008-03-01, 111(5):2505-15.

Acute promyelocytic leukemia (APL) is a distinct subtype of acute myeloid leukemia. Morphologically, it is identified as the M3 subtype of acute myeloid leukemia by the French-American-British classification and cytogenetically is characterized by a balanced reciprocal translocation between chromosomes 15 and 17, which results in the fusion between promyelocytic leukemia (PML) gene and retinoic acid receptor alpha (RARalpha). It seems that the disease is the most malignant form of acute leukemia with a severe bleeding tendency and a fatal course of only weeks. Chemotherapy (CT; daunorubicin, idarubicin and cytosine arabinoside) was the front-line treatment of APL with a complete remission (CR) rate of 75% to 80% in newly diagnosed patients. Despite all these progresses, the median duration of remission ranged from 11 to 25 months and only 35% to 45% of the patients could be cured by CT. Since the introduction of all-trans retinoic acid (ATRA) in the treatment and optimization of the ATRA-based regimens, the CR rate was raised up to 90% to 95% and 5-year disease free survival (DFS) to 74%. The use of arsenic trioxide (ATO) since early 1990s further improved the clinical outcome of refractory or relapsed as well as newly diagnosed APL. In this article, we review the history of introduction of ATRA and ATO into clinical use and the mechanistic studies in understanding this model of cancer targeted therapy.

MIB Abstract ID Number: 14609

PreMedline Identifier: 18299451

*To access this PubMed use the PreMedline Identifier in the PubMed search field

Treatment of adult T-cell leukemia/lymphoma: past, present, and future.

Lead Author: Ishitsuka K

Additional Authors: Tamura K.

Eur J Haematol., 2008-03-01, 80(3):185-96. Epub 2007 Dec 10.

Internal Medicine, Division of Hematology and Oncology, Fukuoka University, Fukuoka, Japan. kenjiishitsuka@fukuoka-u.ac.jp

Adult T-cell leukemia/lymphoma (ATLL) is a peripheral T-cell malignancy caused by human T-cell lymphotrophic virus type I. Clinical manifestations of ATLL range from smoldering to chronic, lymphoma and acute. Patients with acute and lymphoma type ATLL require therapeutic intervention. Conventional chemotherapeutic regimens used against other malignant lymphoma have been administered to ATLL patients, but the therapeutic outcomes of acute and lymphoma type ATLL remain very poor. Promising results of allogeneic stem cell transplantation (SCT) for ATLL patients have recently been reported and the treatment outcome might be improved for some ATLL patients. Besides conventional chemotherapy and SCT, interferon, zidovudine, arsenic trioxide, targeted therapy against surface molecule on ATLL cells, retinoid derivatives, and bortezomib have been administered to ATLL patients in pilot or phase I/II studies. Further studies are required to confirm the clinical benefits of these novel therapeutics. This article reviews the current status and future directions of ATLL treatment.

MIB Abstract ID Number: 14610

PreMedline Identifier: 18081707

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Dendreon Publishes Manuscript on CD54 as a Surrogate Marker of Antigen Presenting Cell Activation

Lead Author: [none given]

PR Newswire. New York: , 2008-03-03

SEATTLE, March 3 /PRNewswire-FirstCall/-- Dendreon Corporation (Nasdaq: DNDN) announced the publication of a manuscript titled, "CD54 is a surrogate marker of antigen presenting cell activation" in Cancer Immunology, Immunotherapy.

The manuscript describes and supports the use of CD54 as a surrogate marker of antigen presenting cell activation (APC) activation and validates its utility as a potency measure of PROVENGE(R) (sipuleucel-T). In particular, it describes how Dendreon researchers used CD54 and the upregulation of its expression on antigen presenting cells (APC) as a means by which human APC activation could be assessed and most importantly, how such measurements could be used to determine the potency of PROVENGE before its administration to patients with prostate cancer. The assessment of product potency is a key release measure required by the U.S. Food and Drug Administration (FDA).

The upregulation of CD54 has been used as part of the potency assay for PROVENGE since the initiation of the PROVENGE clinical development program. Data correlating CD54 upregulation to overall survival in patients from two Phase 3 trials, D9901 and D9902A have been presented at recent scientific meetings and at the FDA Cell Tissue and Gene Therapy Advisory Committee Meeting on March 29, 2007.

MIB Abstract ID Number: 14611

Proquest Identifier: 1438297911

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Zacks Analyst Interview Highlights: Genentech, Amgen and Biogen

Lead Author: [none given]

Business Wire. New York: , 2008-02-26

Zacks.com

Mark Vickery

Zacks Web Content Editor

312-265-9380

Visit: www.zacks.com

Zacks.com releases the latest Analyst Interview. Today's interview is with senior analyst Jason Napodano, who discusses Genentech (NYSE: DNA), Amgen (Nasdaq: AMGN) and Biogen (Nasdaq: BIIB).

A synopsis of today's Analyst Interview is presented below. The full article can be read at http://at.zacks.com/?id=2678.

What is your current price target for Genentech?

My price target for Genentech (NYSE: DNA) is $85. I think that's where fair value is - $85, and that is based on a P/E value 25x '08 earnings of $3.41. We also did a DCF [discounted cash flow] analysis, which is in our research report, so we encourage you to take a look at that. The DCF value that we came up with was $84.

So we feel fair value is somewhere there - $84-85. And hopefully it will get there soon, and maybe it will even keep going, if the sales pick up here based on this news.

So where do you rate Genentech in relation to other big biotech companies, at this point?

You know, big biotech's really been a struggling area. Obviously, Amgen (Nasdaq: AMGN) has had its troubles with the ESA [erythropoiesis-stimulating agents] safety. Biogen (Nasdaq: BIIB) is a company that has a fantastic pipeline, but we've got zeroes across the board for all these pipeline products. It's got a lot of pipeline, but we're just not confident in a lot of it. So big biotech is kind of struggling right now, but I would say with this news - and Genentech is a bellwether - that Genentech vaults as probably our top pick in large-cap bio.

Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today by visiting http://at.zacks.com/?id=2679.

MIB Abstract ID Number: 14604

Proquest Identifier: 1435368721

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Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16.

Lead Author: de Romeuf C

Additional Authors: Dutertre CA, Le Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Béliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Béral H.

Br J Haematol. , 2008-03-01, 140(6):635-43.

LFB Research Department, 70 rue du Dr Yersin, Bioincubateur Eurasanté, 59120 Loos, France. deromeuf@lfb.fr

Patients with chronic lymphocytic leukaemia (CLL) treated with a combination of fludarabine, cyclophosphamide and rituximab show a high response rate. However, only a poor response is observed following rituximab monotherapy. The use of chemo-immunotherapy is often associated with haematological and infectious complications. Thus, an antibody with an enhanced ability to kill CLL cells could lead to better clinical responses to antibody monotherapy and the possibility of lowering drug doses during chemo-immunotherapy. We generated a chimeric anti-CD20 monoclonal antibody (mAb), EMAB-6, which has a low fucose content. Apoptosis and complement activities for EMAB-6 were similar to those seen for rituximab. By contrast, EMAB-6 mAb showed improved Fcgamma receptor IIIA (FcgammaRIIIA)/CD16 binding and FcgammaRIIIA-dependent effector functions. It induced a higher in vitro antibody-dependent cellular cytotoxicity against CLL cells and a higher FcgammaRIIIA-mediated interleukin-2 production by FcgammaRIIIA(+) Jurkat cells in the presence of CLL cells at both low and maximally saturating concentrations. Comparative studies between CLL and lymphoma cells coated with EMAB-6 or rituximab indicated that the difference of efficacy was more pronounced at low doses and when target cells expressed fewer CD20 molecules. Thus, EMAB-6 mAb represents a promising drug candidate for the treatment of CLL by inducing a strong cytotoxicity against tumour cells that express low CD20 levels.

MIB Abstract ID Number: 14612

PreMedline Identifier: 18302712

*To access this PubMed use the PreMedline Identifier in the PubMed search field

Research and Markets: Get A Complete And Comprehensive Analysis Of Genzyme Corporation

Lead Author: [none given]

M2 Presswire, 2008-03-03, Pg. 1

M2 PRESSWIRE-March 3, 2008-Research and Markets: Get A Complete And Comprehensive Analysis Of Genzyme Corporation (C)1994-2008 M2 COMMUNICATIONS LTD

Dublin: Research and Markets (http://www.researchandmarkets.com/ reports/c84593) has announced the addition of "Analysis of Genzyme Corporation" to their offering

Analysis of Genzyme Corporation. A complete and comprehensive analysis of Genzyme Corporation, includes an overview of the industry the company operates in, a PEST Framework Analysis of the industry, and then moves on to analyzing the company itself.

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

MIB Abstract ID Number: 14613

Proquest Identifier: 1437960441

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LEUKEMIA; Research and Markets: Triple Analysis: Decoding Big Pharma's R&D Strategy in Oncology and Special Focus on Leukemias and Lymphomas

Lead Author: [none given]

Lab Business Week, 2008-03-02, EXPANDED REPORTING; Pg. 492

Research and Markets (http://www.researchandmarkets.com/reports/c82915) has announced the addition of "Triple Analysis: Decoding Big Pharma's R & D Strategy in Oncology and Special Focus on Leukemias and Lymphomas" to their offering

This is the report for professionals interested to grasp big pharma's R & D strategy in oncology and at the same time have an extensive R & D overview of the leukemia and lymphoma field. This extensive 500+ pages report compiles and analyzes Deals and alliances, Drug targets, Compound types, Targeted therapy areas, and Selection of cancer indications among the five major pharmaceutical companies in the oncology arena: Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche, and Sanofi-Aventis. Between them and together with their respective partners they have more than 250 drugs for the treatment of cancer. In other words, their collective R & D capacity and presence is solid enough to set trends for the entire field of oncology drug development. Beyond trends, all five are fiercely defining their competitive edge and advantage in oncology and that is what this report is about.

The collective force of the above research and analysis 'decodes' these five big pharma R & D efforts into strategy revealing and gap filing presentations. Enough to fuel and sustain comparative benchmarking, peer group surveillance, and partnership decisions.

The report further give an in depth analysis in two important key oncology areas; Breast- and Prostate cancer. And provide a framework but also a careful identification and evaluation of drug candidates, technologies and competitors.

MIB Abstract ID Number: 14614

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Integration of monoclonal antibodies and immunoconjugates into the treatment of acute myeloid leukemia.

Lead Author: Amadori S

Additional Authors: Stasi R.

Curr Opin Hematol. , 2008-03-01, 15(2):95-100.

aDepartment of Hematology, ‘Tor Vergata’ University Hospital, Rome bDepartment of Medical Sciences, ‘Regina Apostolorum’ Hospital, Albano Laziale, Italy.

PURPOSE OF REVIEW: This review addresses use of monoclonal antibodies and immunoconjugates to treat acute myeloid leukemia. RECENT FINDINGS: Monoclonal antibodies used in acute myeloid leukemia have been directed against the antigens CD33, CD45, and CD66. Unconjugated monoclonal antibodies such as lintuzumab have modest activity against overt acute myeloid leukemia but can eliminate minimal residual disease in acute promyelocytic leukemia. Most experience with immunoconjugates is with gemtuzumab ozogamicin, an anti-CD33 monoclonal antibody linked to the potent antitumor antibiotic calicheamicin. Gemtuzumab ozogamicin has shown activity both singly, particularly in acute promyelocytic leukemia, and combined with conventional cytotoxic chemotherapy. Radiolabeled monoclonal antibodies against CD45 and CD66 have also been used to intensify the conditioning regimen before stem cell transplantation. The most promising results were obtained with radiolabeled anti-CD45 antibodies. Antibodies reactive with CD66 have been used to deliver targeted radiation to hematopoietic tissues in patients with advanced myeloid malignancies. SUMMARY: Both unlabeled monoclonal antibodies and immunoconjugates appear to have a limited role if used as single agents to treat acute myeloid leukemia. These agents hold promise as potentially useful additions to conventional therapy, but the optimal dosing and timing remain to be defined.

MIB Abstract ID Number: 14640

PreMedline Identifier: 18300754

*To access this PubMed use the PreMedline Identifier in the PubMed search field

Treatment of CD33 positive refractory acute lymphoblastic leukemia with Mylotarg.

Lead Author: Cheung KC

Additional Authors: Wong LG, Yeung YM.

Leuk Lymphoma. , 2008-03-01, 49(3):596-7.

<<no abstract available>>

MIB Abstract ID Number: 14641

PreMedline Identifier: 18297542

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Acute myelogenous leukemia associated with Ollier disease.

Lead Author: White MS

Additional Authors: Martin PL, McLean TW.

Pediatr Blood Cancer. , 2008-03-01, 50(3):645-6.

Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.

Ollier disease is a rare disorder characterized by the presence of multiple enchondromas and a propensity to develop malignancies. We report the case of a 7-year-old Caucasian male with Ollier disease who developed acute myelogenous leukemia (AML). This report describes a patient with Ollier disease and AML and may offer a clue into the genetic pathogenesis of these disorders. (c) 2007 Wiley-Liss, Inc.

MIB Abstract ID Number: 14642

PreMedline Identifier: 16991136

*To access this PubMed use the PreMedline Identifier in the PubMed search field

Biotechnology Business; ZymoGenetics Reports Fourth Quarter and Year End 2007 Financial Results

Lead Author: [none given]

Medical Letter on the CDC & FDA, 2008-03-02, pg. 49

2008 MAR 2 - (NewsRx.com) -- ZymoGenetics, Inc. (NASDAQ:ZGEN) reported its financial results for the fourth quarter and year ended December 31, 2007. The results for 2007, particularly the third and fourth quarters, reflect increased costs associated with preparation for launch of RECOTHROM(TM) Thrombin, topical (Recombinant) (also referred to as rThrombin), which was approved by the FDA and launched in January 2008. For the fourth quarter of 2007, the company reported a net loss of $38.6 million, or $0.56 per share, compared to a net loss of $37.1 million, or $0.55 per share, for the prior year period. For the full year 2007, the company reported a net loss of $148.1 million, or $2.17 per share, compared to a net loss of $130.0 million, or $1.94 per share, for the prior year. The increases in net loss reflect not only the company's costs associated with preparation for the RECOTHROM(TM) launch, but also the advancement of clinical stage product candidates.

As of December 31, 2007, the company had $170.9 million of cash, cash equivalents and short-term investments. In addition to this amount, the company will receive a milestone payment of $40.0 million from Bayer HealthCare in February 2008 related to the FDA approval of RECOTHROM, which will be recognized as revenue over the five-year period in which the company will carry out its obligations under the related Bayer collaboration agreements.

"2007 was a pivotal year for ZymoGenetics," stated Bruce L.A. Carter, Ph.D., chief executive officer of ZymoGenetics. "With the launch of RECOTHROM, we've taken our first step towards becoming a profitable, product-driven biopharmaceutical company. Our pipeline of other clinical development candidates, including atacicept, IL- 21 and PEG-interferon lambda, is advancing and is key to achieving our long-term goals," added Dr. Carter.

ZymoGenetics reported substantially higher revenues in 2007 compared to 2006. Revenues were $38.5 million for the full year 2007 and $20.5 million for the fourth quarter, compared to $25.4 million and $4.4 million for the prior year and quarter, respectively. The annual and quarterly increases were primarily the result of higher license fees and milestone payments, partially offset by reduced royalties and option fees. The most significant increases were revenues related to RECOTHROM, rFactor XIII and atacicept, with the majority of these earned in the fourth quarter. Royalties decreased in 2007 due to expiration of certain insulin patents, which was partially offset by increased royalties from other sources. Option fee revenue also decreased due to the November 2006 expiration of an option and license agreement with Novo Nordisk, under which the company earned $6.5 million in 2006.

Research and development expenses for the full year 2007 were $142.3 million compared to $128.5 million in 2006, and for the fourth quarter of 2007 these expenses were $46.0 million compared to $33.8 million in the prior year quarter. The increases, both on an annual and quarterly basis, resulted primarily from the manufacturing of RECOTHROM for commercial use, which the company expensed prior to FDA approval, and from increased clinical research and development costs primarily associated with atacicept, IL-21 and RECOTHROM.

Selling, general and administrative expenses in 2007 totaled $46.9 million for the year and $13.5 million for the fourth quarter, which compares to $33.2 million and $9.1 million reported for the prior year and prior year quarter, respectively. The primary factors contributing to these increases were the deployment of the RECOTHROM sales force during the second half of 2007 and marketing costs associated with RECOTHROM launch preparations, as well as increased legal expenditures.

Net other income in 2007 totaled $2.6 million for the year and $0.3 million for the fourth quarter, which compares to $6.3 million and $1.4 million reported for the prior year and prior year quarter, respectively. These decreases primarily reflect lower investment income, which was largely driven by lower average investment balances.

MIB Abstract ID Number: 14643

Proquest Identifier: 1337003591

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Autoimmune thrombocytopenia in non-Hodgkin's lymphomas.

Lead Author: Hauswirth AW

Additional Authors: Skrabs C, Schützinger C, Raderer M, Chott A, Valent P, Lechner K, Jäger U.

Haematologica. , 2008-03-01, 93(3):447-50. Epub 2008 Feb 20.

Department of Medicine I, Division of Haematology and Haemostaseology, Medical University of Vienna , Vienna, A 1090 Währingergür alexander.hauswirth@meduniwien.ac.at.

Autoimmune thrombocytopenia is a common immunehematologic complication in non-Hodgkin's lymphomas and may complicate the treatment. We analyzed an original series from our institute as well as published cases of non-Hodgkin's lymphomas (excluding chronic lymphocytic leukemia) associated with autoimmune thrombocytopenia with regard to demographic factors, prevalence in non-Hodgkin's lymphoma subtypes and treatment outcome. The male/female ratio is 1.75. Half of the cases occurred prior to diagnosis of lymphoma. Chemotherapy is the best treatment in many non-Hodgkin's lymphomas patients with autoimmune thrombocytopenia compared with standard treatment of autoimmune thrombocytopenia. Splenectomy is effective in splenic marginal zone lymphoma. Autoimmune thrombocytopenia in patients with non-Hodgkin's lymphomas is potentially life-threatening and difficult to treat.

MIB Abstract ID Number: 14644

PreMedline Identifier: 18287133

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Blood stem cell mobilization and collection in patients with chronic lymphocytic leukaemia: a nationwide analysis

Lead Author: E Jantunen

Additional Authors: M Itälä, T Siitonen, T Kuittinen

Bone Marrow Transplantation. Houndmills: , 2008-02-29, Vol. 41, Iss. 3; pg. 239, 6 pgs

MIB Abstract ID Number: 14645

Proquest Identifier: 1428185861

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Vgamma9Vdelta2 T cell cytotoxicity against tumor cells is enhanced by monoclonal antibody drugs-Rituximab and trastuzumab.

Lead Author: Tokuyama H

Additional Authors: Hagi T, Mattarollo SR, Morley J, Wang Q, Fai-So H, Moriyasu F, Nieda M, Nicol AJ.

Int J Cancer. , 2008-02-28, [Epub ahead of print]

Centre for Immune and Targeted Therapy, University of Queensland, Brisbane, Australia.

Vgamma9Vdelta2 T cells exert potent cytotoxicity toward various tumor cells and adoptive transfer of Vgamma9Vdelta2 T cells is an attractive proposition for cell based immunotherapy. Vgamma9Vdelta2 T cells expanded in the presence of Zoledronate and IL-2 express CD16 (FcgammaRIII), which raises the possibility that Vgamma9Vdelta2 T cells could be used in conjunction with tumor targeting monoclonal antibody drugs to increase antitumor cytotoxicity by antibody dependent cellular cytotoxicity (ADCC). Cytotoxic activity against CD20-positive B lineage lymphoma or chronic lymphocytic leukemia (CLL) and HER2-positive breast cancer cells was assessed in the presence of rituximab and trastuzumab, respectively. Cytotoxicity of Vgamma9Vdelta2 T cells against CD20-positive targets was higher when used in combination with rituximab. Similarly, Vgamma9Vdelta2 T cells used in combination with trastuzumab resulted in greater cytotoxicity against HER2-positive cells in comparison with either agent alone and this effect was restricted to the CD16(+)Vgamma9Vdelta2 T cell population. Our results show that CD16(+)Vgamma9Vdelta2 T cells recognize monoclonal antibody coated tumor cells via CD16 and exert ADCC similar to that observed with NK cells, even when target cells are relatively resistant to monoclonal antibodies or Vgamma9Vdelta2 T cells alone. Combination therapy involving ex vivo expanded CD16(+)Vgamma9Vdelta2 T cells and monoclonal antibodies may enhance the clinical outcomes for patients treated with monoclonal antibody therapy. (c) 2008 Wiley-Liss, Inc.

MIB Abstract ID Number: 14646

PreMedline Identifier: 18307255

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Cyclooxygenase-2 independent effects of cyclooxygenase-2 inhibitors on oxidative stress and intracellular glutathione content in normal and malignant human B-cells

Lead Author: Elizabeth P Ryan

Additional Authors: Timothy P Bushnell, Alan E Friedman, Irfan Rahman, Richard P Phipps

Cancer Immunology, Immunotherapy., 2008-03-01, Vol. 57, Iss. 3; pg. 347, 12 pgs

MIB Abstract ID Number: 14647

Proquest Identifier: 1411225451

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Selective induction of apoptosis in leukemic B-lymphoid cells by a CD19-specific TRAIL fusion protein

Lead Author: Julia Stieglmaier

Additional Authors: Edwin Bremer, Christian Kellner, Tanja M Liebig,

Cancer Immunology, Immunotherapy, 2008-02-29, Vol. 57, Iss. 2; pg. 233, 14 pgs

MIB Abstract ID Number: 14648

Proquest Identifier: 1387327461

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Leukemias associated with Turner syndrome: Report of three cases and review of the literature.

Lead Author: Manola KN

Additional Authors: Sambani C, Karakasis D, Kalliakosta G, Harhalakis N, Papaioannou M.

Leuk Res. , 2008-03-01, 32(3):481-6. Epub 2007 Jul 31.

Laboratory of Cytogenetics, National Center for Scientific Research (NCSR) "Demokritos", 15310 Aghia Paraskevi, Athens, Greece.

Cases of leukemia associated with Turner syndrome (TS) are rare. Here we report three TS patients with leukemia including one case of T-large granular lymphocyte leukemia (T-LGL), one rare case of coexistence of chronic lymphocytic leukemia (CLL) and idiopathic myelofibrosis (IMF) and one case of a patient with AML-M2 who received autologous stem cell transplantation (SCT). T-LGL and coexistence of CLL and IMF associated with TS are reported for the first time while the last case represents the first report of SCT in a leukemia patient with TS. Our cases and the limited data of previously reported leukemia patients with TS suggest that TS is not associated with a specific type of leukemia and that presentation, clinical course and response to treatment are similar to that of the non-TS leukemia patients. However, these patients may have a higher risk of liver complications. Interestingly, in the mosaic TS patients, the abnormal clones were restricted to the monosomic 45,X cells, indicating that the leukemic clones possibly originate from the monosomic cell line. Even in cases with no additional chromosome abnormalities, the ratio of X/XX cells in bone marrow cells was significantly increased compared to that in constitutional karyotype, indicating that monosomic cells possibly provide a survival advantage for leukemia cells or that reduced programmed cell death may be responsible for the expansion of the monosomic cells.

MIB Abstract ID Number: 14649

PreMedline Identifier: 17669490

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Small RNAs analysis in CLL reveals a deregulation of miRNA expression and novel miRNA candidates of putative relevance in CLL pathogenesis

Lead Author: [none given]

Additional Authors: S Marton, M R Garcia, C Robello, H Persson, et al.

Leukemia. Baltimore: , 2008-02-29, Vol. 22, Iss. 2; pg. 330, 9 pgs

MIB Abstract ID Number: 14650

Proquest Identifier: 1428192351

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Reports by C. Haferlach and co-researchers describe recent advances in leukemia

Lead Author: [none given]

Science Letter, 2008-02-26, EXPANDED REPORTING; Pg. 1247

"yIn CLL data from chromosome banding analysis (CBA) have been scarce due to the low proliferative activity of CLL cells in vitro. We improved the cultivation technique using an immunostimulatory CpG-oligonucleotide DSP30 and IL-2," scientists writing in the journal Leukemia report.

"A total of 506 CLL samples were analysed with CBA and interphase FISH using probes for the detection of trisomy 12, IgH rearrangements and deletions of 6q21, 11q22.3 (ATM), 13q14 (D13S25 and D13S319) and 17p13 (TP53). A total of 500 of 506 ( 98.8%) cases were successfully stimulated for metaphase generation and are subject to this study. Aberrations were detected in 415 of 500 (83.0%) cases by CBA and in 392 of 500 (78.4%) cases by FISH. CBA detected 832 abnormalities and FISH only 502. Therefore, CBA offers important information in addition to FISH. (1) CLL is characterized mainly by genomic imbalances and reciprocal translocations are rare. (2) A subgroup with complex aberrant karyotype (16.4%) is identified which is associated with an unmutated IgV(H) status and CD38 expression (P=0.034 and 0.02, respectively). (3) Additional abnormalities are detectable providing new biological insights into different CLL subclasses revealing a much more heterogeneous pattern of cytogenetic abnormalities as assumed so far based on FISH data only," wrote C. Haferlach and colleagues.

The researchers concluded: "Therefore, prospective clinical trials should evaluate the prognostic impact of newly available CBA data.'."

Haferlach and colleagues published their study in Leukemia (Comprehensive genetic characterization of CLL: a study on 506 cases analysed with chromosome banding analysis, interphase FISH, IgV(H) status and immunophenotyping. Leukemia, 2007;21(12):2442-2451).

Additional information can be obtained by contacting C. Haferlach, MLL Munich Leukemia Laboratory, Max-Lebsche-Platz 31, D-81377 Munich, Germany.

The publisher of the journal Leukemia can be contacted at: Nature Publishing Group, Macmillan Building, 4 Crinan St., London N1 9XW, England.

MIB Abstract ID Number: 14651

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Motor neuron disease associated with multiple myeloma.

Lead Author: Koc F

Additional Authors: Paydas S, Yerdelen D, Demirkiran M.

Int J Neurosci., 2008-03-01, 118(3):337-41.

Department of Neurology, Cukurova University Faculty of Medical, Adana, Turkey.

The association between Amyotrophic Lateral Sclerosis or other Motor Neuron Diseases (MNDs) with Lymphoproliferative Disorders (LPDs) and plasma cell neoplasias (such as Hodgkin's or non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, multiple myeloma, chronic lymphocytic leukemia) has been described. It is not clear whether LPDs play a role in the pathogenesis of MND; however it is possible that patients might have antibodies against motor neurons. An association between motor neuron disease and Multiple myeloma (MM) is rarely reported in the literature. This article reports a case of a 75-year-old male with MM and MND. Interestingly, the patient was in complete remission for MM when he was diagnosed as MND and he died due to progressive MND.

MIB Abstract ID Number: 14652

PreMedline Identifier: 18300006

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Research results from National Cancer Institute update knowledge of chronic lymphocytic leukemia

Lead Author: [none given]

Science Letter, 2008-02-26, EXPANDED REPORTING; Pg. 710

"We identified 19 persons with B-cell chronic lymphocytic leukemia (CLL) who received genetically identical twin blood cell or bone marrow transplants after high-dose conditioning. Ten are alive (eight disease-free) with a median follow-up of 89 months (range, 31-171 months); 5-year relapse rate was 50% (95% confidence interval (CI), 26-73%)," researchers in the United States report.

"Estimated 5-year survival and disease-free survival were 61% (95% CI, 37-82%) and 45% (95% CI, 23-68%). In two of four patients tested at 12 and 21 months by polymerase chain reaction no evidence of residual CLL was detected post-transplant. In one recipient who relapsed at 6 years, molecular studies showed a different CLL clone from that detected pretransplant. This clone was subsequently identified in the donor suggesting transfer of occult leukemia at the time of transplant. Genetically identical twin transplants can result in long-term disease-free survival and molecular remissions, these data suggest the potential for CLL control in the absence of allogeneic graft-versus-leukemia effect," wrote S.Z. Pavletic and colleagues, National Cancer Institute.

The researchers concluded: "The case of leukemia transfer indicates the need for careful evaluation of donors prior to graft collection.'."

Pavletic and colleagues published their study in Leukemia (Genetically identical twin transplantation for chronic lymphocytic leukemia. Leukemia, 2007;21(12):2452-2455).

For additional information, contact S.Z. Pavletic, National Cancer Institute, Graft Host & Autoimmun Unit, Experimental Transplantation & Immunology Branch, 9000 Rockville Pike, 10 Center Dr., Bethesda, MD 20892, USA.

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

MIB Abstract ID Number: 14653

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