"Since Pro-Pharmaceuticals is in the design stage of phase III based on its phase II study, the company has not applied to the FDA regarding publishing the [phase II] clinical data," the company spokeswoman told me in an email, after she consulted with Pro-Pharma's chief scientist AnatoleKlyosov. [I'm not identifying the spokeswoman because she's nice and is just doing her job. No need to embarrass her any further.]
Naturally, the biotech B.S. detector chip implanted in my brain went into red alert mode after hearing that cockamamie excuse for not sharing old phase II data. The story doesn't get any better after reading what little Pro-Pharma has said publicly about Davanat.
Pro-Pharma claims to have run a phase II study enrolling 25 patients with advanced colon cancer treated with Davanat and the chemo drug 5-FU in which the median overall survival was 6.7 months, or 46% higher than the 4.6-month median overall survival for patients treated with best standard of care.
Except that survival advantage is totally made up because the study treated all patients with Davanat and 5-FU, with no control arm to perform any credible analysis of a survival benefit. Pro-Pharma acknowledges this in the fine print of its corporate slides, stating that the 4.6-month median overall survival for patients treated with best standard of care comes from a "recent publication" i.e. someone else's clinical study.Davanat is supposed to increase the amount of chemotherapy that can be administered to a patient while also decreasing the side effects. After looking at the sparse clinical data available on Davanat, my confidence level in the authenticity of these claims is rather low. Pro-Pharma seems to operate on a shoestring budget, which has forced the halt to several other studies of Davanat. It's not entirely clear if any of the Davanat studies were ever completely finished per design; Pro-Pharma says it stopped the phase II colon cancer study, for example, because "we achieved our objective." Um, but usually, companies complete patient enrollment and treatment before conducting an analysis and concluding that a study's objectives were met. For some reason, Pro-Pharma operates clinical trials backwards. Maybe this is why it's the only company in all of biotech that needs FDA permission to present or publish phase II data?
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