Cancer Vaccines have long been an area of promise in cancer research. And they have been an area of frustration for pharmaceutical and biotech companies. From negative clinical trial results to the FDA changing protocols mid-trial, it is a challenging time to be involved in the development of cancer vaccines.
Cell Genesys ended the trial of its GVAX candidate in prostate cancer back in August (see Cell Genesys Drops GVAX Trial). Now, the company is shedding the majority of its workforce in a desperate bid to stay alive (see SF Chronicle).
Sanofi-Pasteur is one of the largest companies engaged in cancer vaccine research. However, the Sanofi-Pasteur cancer vaccine initiative seems to have gone into deep hibernation and its ALVAC technology hasn’t gone anywhere in recent years. A new melanoma trial is underway, but it will be years Sanofi can evaluate whether the ALVAC technology will continue.
Oncophage from Antigenics has had mixed results, demonstrating increased media survival of four months (see Antigenics’ Oncophage Gets Mixed Results). The product has been approved in Russia and now has an FDA export certificate, but Oncophage does not have regulatory approval in the U.S. or EU. Antigenics has filed for EU approval, so this is one to watch. I like Antigenics chances.
Finally, who could forget Dendreon? Their lead candidate Provenge received a resoundingly positive Advisory Committee endorsement, only to be torpedoed in a back room deal with the devil between Dr. Howard Scher and the FDA’s Richard Pazdur (see Can Provenge Get Any Weirder?). The company has had to go back to the drawing board on the trial data. I believe Provenge will ultimately be approved, but it will take a long time because they FDA does not want to lose face in the way it has mishandled this review.
Cancer vaccines offer promise, but many challenges still remain.
Thursday, October 23, 2008
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1 comments:
Surely you already know that Dendreon's Provenge had an INTERIM look at their IMPACT clinical trial--a 3rd Phase III clinical trial at the beginning of October--several weeks ago.
The data showed a 20% reduction in death in the Provenge treated patients when compared to deaths in those in the Control group who are given BOTH the standard of care--horrible chemo, Taxetore--AND, upon disease progression, a treatment with reduced Provenge.
So, despite the Provenge arm patients competing against the current standard of care--Taxetore--it is also competiting against itself and, yet, it showed such a large positive effect on patients.
You also neglected to be fully informative regarding Cell Genesys. The reason for the recent massive layoffs is not strictly due to the August clinical trial stoppage.
They had a second clinical trial running and the IDMC looked at their data and advised that 2nd clinical trial also stop effective just 10 days ago.
Currently, Provenge is the only product showing postive results for prostate cancer patients who take it, but it's the only game in town left after Novacea's PIII trials were likewise stopped a year ago; no one is anywhere close to the goal line like Provenge is.
And, I have NEVER seen the Provenge saga so aptly described... a deal with the Devils: UNdisclosed Conflict-of Interests Howie Scher and the FDA's own Dr. No, Dick Pazdur. Most apprapro! Merci!
Thanks for you article on what's happening in the field.
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