Biosante Scores, Trial News and Orphan Drug Designation (BPAX)
Biosante Pharmaceuticals, Inc. (NASDAQ: BPAX) is not your normal big mover, and it does not yet emulate what we would pen as the “chase for the next ten-bagger” where investors are looking for 1,000% gainers. But the company is seeing a surge in shares this morning after releasing additional positive Leukemia vaccine results on the GVAX AML vaccine AND on BioSante’s receipt of an FDA award of the Orphan Drug designation.
The Orphan Drug status pertains to the treatment of acute myeloid leukemia, or AML. This is actually the second GVAX cancer vaccine from BioSante to secure FDA orphan drug designation.
Today’s news noted that a paper published in the peer-reviewed journal “Blood” showed that clinical investigators led by Johns Hopkins University shed light on the results of a Phase II study of GVAX AML which was accompanied by immunotherapy-primed lymphocytes after autologous stem cell transplantation in hematologic malignancies. The article noted that immunotherapy in combination with primed lymphocytes and autologous stem cell transplantation did show encouraging signals of potential activity in AML.
The findings showed that 54 subjects were enrolled in the study. Of those enrolled, 28 patients or 52% received a pre-transplantation GVAX AML dose. It notes that a total of 46 or 85% of subjects achieved complete remission during the treatment period. For all patients who achieved complete remission, the 3-year relapse-free survival rate was 47.4% compared to 61.8% in the GVAX-treated group. While the overall survival rate in all subjects was 57.4%, it was 73.4% in the GVAX-treated group.
Again, this is no ten-bagger. At least not yet. It will be interesting to see what happens with the figures in a larger study. Tests with just over 50 patients often have many changes in their results.
At 11:00 AM EST we have shares up 6.3% at $1.86 on 1.4 million shares. The average volume is only about 595,000 shares and the 52-week trading range is $1.14 to $2.70. The market cap here is only $99.8 million, so this is still a micro-cap stock by most counts.
JON C. OGG
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Great information! I’ve been looking for something like this for a while now. Thanks!
Looks good in orange! Justice is served.