FDA withdraws hold on GTx’s prostate cancer drug

Posted under Blog, Cancer Drugs, Clinical Trials, Companies, Diagnostics, FDA, Funding, GTx, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, Prostate Cancer, Regulatory, Startups, Universities, Videos by rmcbride

GTx ($GTXI) is back on track to begin a mid-stage study of its drug Capesaris. The FDA lifted a clinical hold on the experimental cancer drug after reviewing the company's response and plans for a Phase II study involving patients with castration-resistant prostate cancer.  

Memphis-based GTx now aims to launch the mid-stage trial in the third quarter, testing the drug in 75 men at three lower doses, the company said today. The study aims to measure safety and efficacy of the hormone therapy in men with aggressive prostate cancers.

U.S. regulators placed the program on hold in February after GTx revealed to the agency an increased risk of clotting. The safety risk was seen in patients treated with higher doses of the drug than the company plans to test in the revamped Phase II trial. The upbeat development pushed the company's stock price up nearly 20% to $3.72 this morning, helping the price regain some lost ground since the clinical hold made news.

GTx also said today in a corporate update that the company is enrolling patients for two late-stage studies of Ostarine for combating muscle wasting in patients with advanced non-small cell lung cancer. The update included results for the first quarter, which said that the company had $64 million in cash equivalents and other short-term investments as of March 31.

- here's the release on Capesaris
- see Reuters' update

Related Article:
GTx shares tumble after clot threat forces hold on prostate cancer drug

Oregano attacks prostate cancer cells in lab experiment

Posted under Blog, carvacrol, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Prostate Cancer, R&D, Startups, Universities, Videos by john

Scientists report that a chemical in oregano, carvacrol, effectively killed off prostate cancer cells in a lab experiment. The chemical could now be used as the basis for a new experimental treatment for prostate cancer. "Some researchers have previously shown that eating pizza may cut down cancer risk," says Supriya Bavadekar. "This effect has been mostly attributed to lycopene, a substance found in tomato sauce, but we now feel that even the oregano seasoning may play [a] role." Story

Sanofi colorectal cancer contender Zaltrap suffers a PhIII trial setback

Posted under Aflibercept, Blog, Chris Viehbacher, colorectal cancer, Companies, Diagnostics, FDA approval, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Prostate Cancer, Regeneron, Regulatory, Sanofi, Startups, Universities, Videos, Zaltrap by john

Sanofi and Regeneron opened their update on the cancer drug Zaltrap (aflibercept) on a sweet note: The FDA has granted a priority review of their new drug application for colorectal cancer. But the news wrapped a bitter pill, as they quickly went on to acknowledge that their cancer contender had failed a late-stage study for prostate cancer.

The Phase III Venice study involving patients with metastatic, androgen dependent prostate cancer "did not meet the pre-specified criterion of improvement in overall survival," the companies reported. No data was put out in the release and investigators noted that they would review the results at a later scientific meeting.

Last fall, as analysts were growing increasingly skeptical about Sanofi ($SNY) CEO Chris Viehbacher's (photo) promise for better results from the pharma giant's restructured R&D operation, the company listed Zaltrap as one of its top late-stage prospects in the pipeline. Today's mixed news may not help much in making its case for a turnaround, but the primary focus in R&D has long been on the positive colorectal cancer results seen in Phase III. And that's the note Sanofi was trying to stay focused on today.  

"Sanofi and Regeneron are committed to the continued development of Zaltrap and we are very pleased that the FDA has chosen to grant priority review to Zaltrap in metastatic colorectal cancer," said Debasish Roychowdhury, who heads up Sanofi's cancer drug work. "We look forward to working closely with the FDA to potentially bring an important new option to patients with this difficult disease."

The target date for their application on colon cancer is August 4. 

- get the press release
- here's the Reuters story

Related Article:
Sanofi, Regeneron buoyed by PhIII colon cancer success for aflibercept

High-profile investigator tapped to lead $10M prostate cancer program

Posted under abiraterone, ARN-509, Blog, Companies, Diagnostics, Funding, MDV3100, Medical Devices, Medical Supply, personalized medicine, Pharmaceuticals, Prostate Cancer, Startups, Universities, Videos by john

Charles Sawyers, a high-profile cancer drug specialist at Memorial Sloan-Kettering Cancer Center, has been tapped to help lead a $10 million effort to test personalized treatments for prostate cancer. He and a "dream team" of clinical investigators will test various combination therapies, including abiraterone. Sawyers played a leading role in the discovery of MDV3100 and ARN-509, two closely watched prostate cancer treatments now in development. Story