Not quite sure what to make of this - sure is an unpleasant surprise for the shorts that didn't cover, though.
Allos Hopes to Find a Friendly FDA
By TSC Staff
05/29/2003 03:52 PM EDT
Allos Therapeutics (ALTH:Nasdaq - news - commentary - research - analysis) plans to submit a new drug application to the Food and Drug Administration for a treatment aimed at brain tumors caused by the spread of breast cancer, even though the product didn't meet the main goal of a study in which it was involved earlier this year.
The company said its decision follows a meeting with the FDA in which Allos presented preliminary safety and efficacy data from a Phase III clinical trial and, specifically, the results in patients with metastatic breast cancer. The drug, efaproxiral, is currently known as RSR13.
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Allos released preliminary results of the Phase III trial in April, saying that the difference in overall survival between patients with brain metastases who received RSR13 plus whole brain radiation therapy and those who received only radiation therapy wasn't statistically significant. But at the time, Allos said the trial did show a positive survival benefit among patients with metastatic breast cancer.
The NDA filing will be based on the subset of metastatic breast cancer patients. In the Phase III study, there were 115 such patients in this subgroup. The overall study of 538 patients showed no survival benefit for RSR13. In others words, Allos is taking a subgroup of just 115 patients -- and one that wasn't an intent-to-treat subgroup -- and using that as the basis for an FDA filing.
Some industry observers have indicated that the FDA appears more willing of late to consider new drug candidates. But with such a small test group in the case of Allos, the agency could eventually ask for more data from the company to let the public know that it hasn't allowed its standards to lapse.
(Adam Feuerstein, a columnist for TheStreet.com's sister site RealMoney.com, offered some insight on Allos and the FDA in the Columnist Conversation today.)
Allos, a small biopharmaceutical company based in Colorado, said it expects to complete the application in the fourth quarter of this year. |
