|ImmunoCellular: ICT-107 Fails Phase II Trial on Lack of Survival Benefit|
|By Staff and Wire Reports|
|Thursday, 12 December 2013 11:04|
The press release issued by the company yesterday (link) was actually a bit misleading to investors, suggesting that the clinical trial proved that the patients in the ICT-107 arm actually saw a survival benefit. While this is true from a raw numbers standpoint (the media OS was higher in the ICT-107 arm), investors should note that the p-value must be between 0-.05 for the company to make any official claims. From the release:
“The differences in the overall survival (OS) K-M curves did not reach statistical significance in the intent-to-treat population (the primary endpoint) or the per-protocol population, with p-values and HRs of p=0.58 two-sided, HR=0.87, and p=0.40 two-sided, HR=0.79, respectively. However, there were numerical differences in the median survivals favoring ICT-107 of two months in the intent-to-treat population and three months in the per-protocol population.”
It was also unfortunate that the OS failure occurred in a decently-large patient population. The trial had 124 evaluable patients, of which 67 received ICT-107. However, the p-value was nowhere near acceptable.
It appears that the market has wiped out almost all the value of ICT-107 from the valuation of the company, which is fair given the results. However, it appears as though Immunocellular will attempt to move into Phase III trials given these results:
“John Yu, MD, Founder, Chairman and Chief Scientific Officer of ImmunoCellular Therapeutics, said, "We are quite pleased to see such a strongly statistically significant result in PFS in this exploratory trial, and believe that in conjunction with the indications of a survival benefit, these results provide a strong medical rationale for continued development of ICT-107 as a potential treatment for glioblastoma. We look forward to discussing this important clinical outcome, and what next steps, including a phase III trial, might entail, with the FDA in an end-of-phase-II meeting."
Although investors may like having another chance at approval for ICT-107, it must also be considered that ICT-107 would incur large expenses for a Phase III trial. This trial would have a very low chance of success (judging by the current results of Phase II), even if alternations were made.
But the game isn’t truly over for IMUC, and there are two other drugs in the pipeline including ICT-121 and ICT-140. These are Phase I and preclinical compounds, respectively.
Immunocellular is currently valued at ~63 M, which isn’t too bad when you consider that the company has $29 M in cash and no long-term debt. It may be worth it to catch this falling knife due to the altered risk/reward ratio after the failure of ICT-107, but investors should realize the heightened risk that they are being exposed to. The entire vaccine platform that the company’s pipeline is based on is now in question by the FDA, Wall Street, and possibly the company itself.