BPAX recent happenings

A few notes and updates from a somewhat busy week for BioSante Pharma (BPAX):

• First, BPAX announced recently that the first of two 500 patient efficacy phase 3 trials for Libigel has complete enrollment
• BPAX also gave a presentation at the Citi Global Markets 2011 Healthcare Conference- click here for webcast link
• Here are a few noteworthy comments/updates from the presentation:

1. Second Libigel efficacy trial should be enrolled by the end of March 2011
2. If full 4000 pts are needed, the Libigel safety trial would hit that enrollment milestone around June-July 2011
3. The safety trial data monitoring committee will meet again in May, or earlier in the event of any new CV event in the trial
4. The efficacy trials are on track to have top-line data results in September-October 2011
5. BPAX is currently burning about $4m per month
6. BPAX has re-initiated partnering talks for Libigel.  As of last fall, the company identified the completion of enrollment as a key gating metric for partnering discussions.  They also guided for a partnership in next 6-12 months at that point, seeking to probably partner before NDA filing, and certainly before approval/launch.  The company has always openly said that a sale of the entire company would also be considered

• This week BPAX also released data from a phase 2 trial of their pancreatic cancer vaccine (formerly known as GVAX when owned by Cell Genesys CEGE before GVAX prostate disaster and merger).  This news spiked BPAX shares briefly back to the $2.50 range before people came to their senses.  Here is a recap of the data-

1. The single arm phase 2 study was conducted in 60 pancreatic patients at Johns Hopkins 
2. Patients receiving the cancer vaccines had median overall survival of 24.8 months and a one year survival rate of 85%
3. These data compare favorably to published historical median survivals of 15-20 months and one year survival rates of 63%
4. However, BPAX openly and blatantly committed the cardinal sin of directly comparing the current trial data to historical averages- this is unacceptable and meaningless, and quite disappointing to me as a scientist and potential investor.  It is one thing to reference the historical rates and state your new trial results that are "better."  But BPAX went so far as to put in the heading of the press release that "median survival increased by more than 25%"--- this statement is not acceptable medically, statistically, or ethically

• Of course then, in classic BPAX fashion, the day after this shady, hyped press release, BPAX announced another financing offer thru Rodman and Renshaw, laden with millions of warrants, causing the share price to plummet back below $2.00
• These continual stock offerings in a pump-and-dump manner have greatly diluted the shareholders and left an unbelievable warrant overhang that you must take into account when trying to value the Libigel program and BPAX. Click here for the gory details of all the stock sales and warrants on the BPAX research page
• As Libigel progresses and seems likely to succeed, and as BPAX continues to undermine the value and integrity of their company, Antares Pharma (AIS)- click here to visit the AIS research page, the owner of Libigel rights in the rest of the world, plus manufacturing rights and the rights to royalties (single digit) and a portion of BPAX's licensing income, has largely not benefited in terms of share price appreciation- and is becoming a more attractive way to play Libigel in my opinion