This is the second part of why Cel-Sci's survival claim for Multikine is misleading. To read Cel-Sci Cancer Drug Claims Crumble (Part 1), click here. Now, let's swing back to Cel-Sci's dubious claim that Multikine extended survival of these 19 head and neck cancer patients by 33% compared with standard of care. Cel-Sci first launched this canard in a press release issued on Feb. 21, 2006, when it announced the results of a long-term follow-up of the patients in the Hungarian phase II study. The release states: "The median follow-up period for the patients was 3.2 years. The results of the Phase II trial follow-up study showed that the Multikine-treated patients had substantially increased survival rates and achieved a higher rate of 2-year local regional control as compared to the survival and the 2-year local regional control rates published in the scientific literature (39 clinical trials between 1987 and 2004 in a similar population of head & neck cancer patients)." Did you catch that? The Multikine-treated patients lived longer than patients collected from 39 totally separate studies published over the course of seven years. Cel-Sci has no data on the real survival benefit of Multikine from a randomized, controlled study, so it arbitrarily compares the drug to studies found in the scientific literature between 1987 and 2004. Why these studies? Why these years? Why not 1986 or 2005? Cel-Sci doesn't say.
On May 23, 2006, Cel-Sci issued another press release that tries to quantify Multikine's 33% survival benefit: "The median overall survival (calculated by including death from any cause of patients in the trial, even deaths not related to the disease) of the 19 evaluable patients in the follow-up portion of this clinical trial was 63% at a median follow-up of 40 months post-surgery. The results of the published scientific literature (39 OSCC clinical trials published between 1987 and 2004) document that survival at 3 1/2 years is approximately 47% following standard of care treatment. The addition of Multikine to the standard of care treatment resulted in a 33% increase in overall survival over the results published in the literature." Much is wrong with this statement. For starters, median overall survival is always expressed as a unit of time (weeks, months or years) not as a percentage. What Cel-Sci is trying to say, clumsily, is that 63% of the 19 Multikine-treated patients were alive at a median follow-up of 40 months post surgery. Absent data from patients in the same study not treated with Multikine, this survival statistic is meaningless. But again, Cel-Sci pulls data from old and arbitrary head and neck cancer studies to conclude that the 3 1/2-year survival rate for non-Multikine-treated patients is just 47%. If Cel-Sci went to the FDA with this survival data, the company wouldn't get through the front door. Yet Cel-Sci wants investors to believe that the phase II studies demonstrated a "survival benefit" for Multikine compared to standard of care. That's a nonsensical claim.
There's more. On May 21, 2007, Cel-Sci issued another press release on the Multikine survival advantage. At first glance, the announcement seems to mimic the May 2006 release, except for this passage: "The addition of Multikine to the first treatment (standard of care) of these patients resulted in a 33% improvement in the median overall survival at 3-1/2 years post-surgery, when compared to the survival results reported in 55 OSCC clinical trials published in the scientific literature between 1987 and 2007."
Emphasis added. Cel-Sci pulled a switcheroo with the comparator studies! Instead of the 39 head and neck cancer studies cited in 2006, Cel-Sci has suddenly found 55 studies. And the studies now encompass the years 1987 through 2007 instead of 1987 through 2004. I asked Cel-Sci to provide further documentation of the comparator studies it used to make the Multikine survival claims as well as copies of any data presentations but the company declined to respond. The only legitimate way to test a cancer drug's ability to prolong survival is to design and conduct a randomized, controlled clinical trial. To its credit, that's what Cel-Sci plans to do this summer when it begins enrollment in an 800-patient phase III study that will randomize patients to treatment with either Multikine plus the standard of care or the standard of care alone. When this study is completed in three or four years, Cel-Sci and investors will know definitively whether Multikine can extend the lives of head and neck cancer patients. But as I pointed out clearly, there is very little supportive data from the published phase II study of Multikine to provide any measure of comfort or confidence for a positive outcome from the phase III survival study.
When Kersten gets up in front of investors like he did Tuesday and makes false and misleading claims about a 33% Multikine survival benefit, investors should understand that he's selling a dream, a lottery ticket, and nothing more. The odds are better in Vegas. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.