I don't usually write about the starts of clinical trials, and I've even been known to send snarky replies to PR people who pitch them to me via email. I mean, really, tell me when the thing ends; that's the data investors care about, since it drives the stock price.
So I found it curious that CEL-SCI (AMEX: CVM) shot up more than 25% Wednesday when the company announced it was starting a phase 3 trial testing its cancer therapy Multikine as a treatment for newly diagnosed head and neck cancer patients. Shares eventually settled up more than 8% -- still an impressive gain considering the seemingly mundane announcement.
Did CEL-SCI suddenly figure out a way to start and complete a clinical trial in one day? Was there something in the press release that gave investors additional confidence that Multikine would work? Not that I can see.
As best I can tell, this was just investors saying, "Finally!" The trial, which it's running with Teva Pharmaceutical (Nasdaq: TEVA) and Orient Europharma, was supposed to start in the third quarter, and CEL-SCI has been talking about it since January 2007. Momentum day traders probably helped it along.
There's likely also a little excitement as investors look at CEL-SCI as the next Dendreon (Nasdaq: DNDN). Multikine is a cancer immunotherapy like Dendreon's Provenge, but unlike Provenge, which takes patient's cells and activates them at Dendreon's facility before putting them back into patients, Multikine acts internally to train the patient's immune system to attack the tumor. It's easier to manufacture since it isn't a personalized treatment, but whether it'll make it more likely that the treatment will help cancer patients remains to be seen.
The phase 3 trial looks well-planned, but I don't see much reason to jump in at this point. It's not clear that Multikine will work -- the phase 2 trial didn't have a control group -- and it's going to take a long time to get an answer. The endpoint is overall survival, which CEL-SCI believes will take three years in the standard of care group and hopefully longer in the Multikine group.
Investors looking for a company that's a little further along would be better off looking at Regeneron Pharmaceuticals (Nasdaq: REGN), which will see readouts from three phase 3 trials for its cancer drug Aflibercept over the next year. For now, keep CEL-CSI at the bottom of your watchlist.
