Biotech Values

[walldiver]

MOGN...trying to figure out why they got an approvable letter with a requirement of a new Phase III for Saforis, a therapeutic agent for the treatment and prevention of oral mucositis, a condition resulting from chemo. All the info is difficult to come by, probably because in 2004, MOGN bought out the private company that conducted all of the clinical trials. The Phase III was presented at the 2004 ASCO...it hit the primary endpoint and a couple secondary endpoints. All indications seem to be there was no SPA for Saforis. There is currently no approved treatment for Saforis, and the adverse event profile was similar to placebo.

Here is the 2004 ASCO abstract
http://tinyurl.com/ycuqz9

You can also pull up the slides by scrolling down a little further below the abstract...scratching my head here, perhaps it's the lack of an SPA, and/or oral mucositis can currently be treated by an off-label drug?

There was a 22% reduction in Grade 2 oral mucositis (p=0.027, primary endpoint). For Grade 3 (severe) OM, 11/160 placebo patients contracted it compared to 2/160 Saforis patients. A slightly higher % of placebo patients suffered from adverse events.

It's also possible that there was a confounding crossover effect...some of the literature mentions it, but there is not enough info in the abstract or the slides to figure out exactly how they designed the crossover into the trial.