FLICKR, SLGCKGCFollowing the completion of a 12-person, Phase 2 trial testing its drug candidate, GM604, for the treatment of amyotrophic lateral sclerosis (ALS), California-based biotech Genervon announced “very robust” and “dramatic” results and applied to the US Food and Drug Administration (FDA) for accelerated approval. If granted, the status would allow the company to skip Phase 3 trials for the drug, following up with additional studies after it hit the market. ALS patients have petitioned for the approval of GM604; researchers have demanded caution.
The FDA has remained tight-lipped on the issue, as by law it cannot discuss ongoing drug evaluations. Instead, the agency last week (April 16) called on the company to publicly release the all data from the Phase 2 study, rather than a mere summary of the results, upon which advocates and skeptics have so far based their arguments.
“We call upon Genervon to release all the data from their recently completed trial in order to allow a more informed discussion of the trial findings among ALS stakeholders,” the FDA wrote. “Such a release should include the pre-specified clinical outcome measures as assessed by change from baseline observations that were taken just prior to randomization to drug or placebo. Such data provide the strongest basis to ...
