Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has notified Avax Technologies that it has been cleared to launch its phase III registration study for M-Vax, its vaccine therapeutic for the treatment of skin cancer.
Subscribe to our email newsletter
The FDA and Avax have agreed on the trial design and endpoints under a special protocol assessment which will also expedite review of the product.
“Our initial phase II data in combination with more recent publications and patient reports in our compassionate use program provides us with a high degree of confidence that M-Vax may be a promising treatment option for patients suffering from metastatic melanoma,” noted Dr David Berd chief medical officer of Avax.
The primary endpoints of the phase III study are best overall anti-tumor response rate and the percentage of patients surviving 2 years. Secondary endpoints of the study will include overall survival time, response duration, percentage complete and partial responses, progression free survival and treatment related adverse events.
Avax estimates that the interim study data analysis of response rate could occur in 2008, with the final response rate evaluation expected in 2010 and overall survival data generated in the 2012-2013 timeframe.