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BioSante Announces Positive Data on Leukemia Drug

BioSante Pharmaceuticals may be known for its sexual health products such as LibiGel, but the Illinois-based company is also developing a novel immunotherapy vaccine to treat cancer. The company announced Wednesday that its GVAX Leukemia Vaccine demonstrated the ability to reduce or eliminate the last remaining cancer cells in patients with chronic myeloid leukemia (CML) who were taking the cancer drug Gleevec. Although Gleevec is effective in helping CML patients achieve remission, cancerous cells still remain in most patients. These cells can cause a relapse.   GVAX is comprised of irradiated CML cells that have been genetically altered to produce an immune-stimulating protein. The cells also carry antigens that can provoke the immune system to recognize and kill cancer cells. The 19 patients who participated in the study had been taking Gleevec for more than a year, and continued to take Gleevec while they were given the GVAX Leukemia Vaccine. Patients were followed for a median of 72 months. After that time, cancer cells decreased in 13 patients. CML became undetectable in 7 patients. Side effects of GVAX included pain and swelling at the injection site, occasional muscle aches and low fevers. BioSante has an eclectic pipeline that includes LibiGel, a testosterone gel for female sexual dysfunction; Elestrin, an estradiol gel for menopause symptoms; and Bio-T-Gel for the treatment of hypogonadism in men. The company is also developing a facial line filler, a vaccine adjuvant for infectious diseases such as HIV and swine flu, and a drug delivery system using the company's calcium phosphate (CaP) technology. Shares in BioSante rose 7 percent Thursday following the announcement of the GVAX data. Earlier this week, the company announced that it had raised $17.5 million in a stock sale.

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