OBR Daily Commentary

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Astex Pharmaceuticals Announces Initiation of AT13387 Phase 2 Study in Non-Small Cell Lung Cancer

(Yahoo! Finance) Oct 24, 2012 - Astex Pharmaceuticals, Inc., a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that it has initiated an open label, randomized, controlled, multi-center, Phase 2 clinical trial, evaluating HSP90 inhibitor AT13387 in anaplastic lymphoma kinase positive (ALK +) non-small cell lung cancer patients or other potentially crizotinib-sensitive NSCLC patients who have been receiving crizotinib.

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H. Jack West, MD (Posted: October 24, 2012)

quotesSeveral HSP90 inhibitors have demonstrated activity in ALK+ NSCLC, so this appears to be a very encouraging, though numerically limited, setting in which to study AT13387 and potentially other HSP90 inhibitors. It is also gratifying to see a greater focus on clinical trials for patients with a driver mutation like ALK or EGFR who have developed acquired resistance to the initial targeted therapy, hoping to restore activity with a new agent against that target or a combination with the prior targeted agent, as is being done in the planned trial with AT13387.quotes

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Peregrine Says Lung Cancer Trial Data Erroneous, Shares Sink

(Reuters) Sept 24, 2012 - Peregrine Pharmaceuticals Inc said it found major discrepancies in results from a mid-stage study of its experimental lung cancer drug conducted by a third-party contractor, wiping off nearly three-quarters of its market value.

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H. Jack West, MD (Posted: September 24, 2012)

quotesOf course, anyone would be encouraged by the results that were presented by Dr. David Gerber earlier this month at the Chicago lung cancer meeting, which included an approximate doubling of median overall survival for previously treated patients with advanced NSCLC in the two groups in the randomized phase II trial who received bavituximab in combination with docetaxel, compared with docetaxel alone. Despite this, I feared what I saw was "irrational exuberance" over results of what was still a phase II trial with about 40 patients per arm and favored learning more from the planned phase III randomized trial before declaring bavituximab a miraculous intervention. The press release highlight "major discrepancies in treatment group coding", providing very little actual information, but it does caution investors to not consider the previously released data to be credible. We will need to learn more as Peregrine sifts through the wreckage to determine the extent of the errors, hoping this isn't flagrant fraud. In the meantime, the ongoing story provides a sobering reminder that "if it seems too good to be true, it probably is." It is a shame that this situation could undermine the credibility of the research process at a time when there are other stories of unethical conduct in clinical trials that could lead the public to be wary about the integrity of the process.quotes

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Threshold Falls on Pancreatic Cancer Study Results

(Bloomberg Businessweek) Sept 17, 2012 - Threshold Pharmaceuticals Inc. tumbled the most in almost four years after its experimental pancreatic cancer drug didn’t significantly improve patients’ overall chance of survival.

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H. Jack West, MD (Posted: September 17, 2012)

quotesJust disappointing to me that seeing a 2 month survival benefit in a phase II trial is a crushing blow to the development of a potentially useful drug. I had been intrigued by TH-302 activity in lung cancer, and I still feel that the efficacy looks favorable in pancreatic cancer as well. The fact that it didn't lead to a significant survival benefit in a phase II trial, even if that difference in survival was relatively impressive at 2 months, seems like throwing away the baby with the bathwater here.quotes

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Meet the Editorial Board

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Associate Cancer Center Director, Yale Cancer Center P...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...