Galectin Therapeutics Inc. (GALT)

[sunspotter]

"This is playing like a P&D."

The track record of Jim Czirr and Peter Traber suggests that this is exactly what GALT is.

Nothing real has changed since Adam Feuerstein's dissection of GALT back in the day, apart from a few deckchairs being shuffled around on the deck of Titanic by re-naming and allegedly re-purposing the same old compound:

"Alex M. writes, "A colleague mentioned he had been persuaded to buy Pro-Pharmaceuticals(PRWP.OB) a few years back, and after years of languishing in losses, he's wondering whether it's actually a real company with a real drug candidate, Davanat, or whether it's an out-and-out scam or somewhere in between... Do you have a view on this company? I'm a huge admirer of your column, and have to admire anyone who flushes CEOs of companies like Generex(GNBT) and Cell Therapeutics(CTIC) out of the woodwork in the way you have. I suspect that makes you eminently qualified to comment on Pro-Pharmaceuticals."

I called the public relations people working with Pro-Pharma on Wednesday asking for slides and/or published articles so that I could review the phase II data on Davanat in colon cancer, the drug's lead indication.

Pro-Pharma's spokeswoman explained to me the company hasn't presented or published any of the Davanat data (from a study conducted in 2004-2006) because the FDA places "serious restrictions" on publishing clinical data without the agency's approval.



"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?

On Wednesday, Pro-Pharma said it was moving ahead with plans for a commercial launch of Davanat in Colombia. That's Colombia, the country in South America. Apparently, Colombia President Alvaro Uribe is really excited about bringing Davanat to all Colombians suffering from colon cancer.

I'll stop now. Alex, I hope you have your answer."

-- Reported by Adam Feuerstein in Boston.

http://www.thestreet.com/story/10741455/3/biotech-stock-mailbag-aspenbio.html