GTXI data by YCharts
) -- Don't for a second believe
CEO Mitch Steiner's B.S. spin about a potential survival benefit emerging from the failed phase III studies of enobosarm. Steiner is simply desperate to keep his company's stock price trading above cash where it belongs.
GTx shares are down 62% to $1.57 following the disclosure Monday that enobosarm failed to increase lean body mass and improve physical function across two phase III studies of non-small cell lung cancer patients.
The negative trial results for enobosarm, a selective androgen receptor modulator (SARM), come as no surprise to any investor who
dug deep into the previously reported -- and deeply flawed -- phase II study
. [GTx shares are down almost 80% since I outlined the significant risks to the enobosarm studies.]
Now, let's discuss Steiner's ridiculous claim that enobosarm might be helping these lung cancer patients live longer.
Steiner says lung cancer patients who gained lean body mass during the course of the trials -- "enobosarm responders" -- appear to be living longer than the patients who continue to lose lean body mass i.e. the "enobosarm non responders."
Take a moment to let the derpish obviousness of this statement sink in. Patients who respond to a drug demonstrate a benefit compared to those who do not. Um... okay? This revelation and $2 will buy Steiner a tall coffee at Starbucks. It will also get him laughed out of meetings with U.S. and European regulators when he tries to convince them to approve enobosarm on two failed clinical trials.
GTx is engaging in classic biotech mis-direction. There is no credible evidence from these trials that enobosarm is associated at all with a survival benefit. [Memo to Steiner: Perhaps some lung cancer patients are living longer because they're actually responding to chemotherapy. You ever think of that?] The company admits as much in today's press release:
"In the safety analysis of survival, there was no evidence of a difference between patients treated with enobosarm and placebo in either clinical trial."
Anything other claims about survival made by Steiner is just classic biotech mis-direction. Don't fall for it.
-- Reported by Adam Feuerstein in Boston.