Shares of BioSante Pharmaceuticals rose 10 percent after the company reported positive results from a clinical study of a leukemia vaccine.
The Phase 2 trial showed that BioSante’s GVAX vaccine “may be able to reduce or eliminate” the last remaining cancer cells in patients who are suffering from chronic myeloid leukemia and taking the drug Gleevec, according to a statement from BioSante.
The news sent BioSante’s stock price up 10 percent to $1.88 in late-morning trading.
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Chronic myeloid leukemia is a cancer of the blood cells that can be treated by Gleevec, a drug from Novartis that was approved by the U.S. Food and Drug Administration in 2001.
Gleevec destroys most leukemic cells in the body, but in most patients, some cancerous cells remain and cause relapse. That’s where BioSante’s vaccine comes in–eliminating those remaining cancer cells.
The study followed 19 leukemia patients for a median of 72 months. Of those patients, 13 showed a decrease in cancer cells, according to the statement.
“We want to get rid of every last cancer cell in the body and using cancer vaccines may be a good way to mop up residual disease,” said Dr. Hyam Levitsky, a Johns Hopkins University professor who led the study.
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Levitsky cautioned that more research is needed to confirm and expand the study’s results.
BioSante Chief Executive Stephen Simes said in a phone interview that the company is at least several years away from seeking FDA approval of GVAX. The vaccine is currently in the midst of three separate Phase 2 studies for leukemia.
Last week, BioSante said it raised $18 million in a stock sale. The company plans to use the cash to fund a Phase 3 study of LibiGel, a transdermal drug that treats under-active sexual desire in menopausal women. BioSante plans to complete the trial next year and seek FDA approval of the drug next summer, Simes said.
BioSante has one drug on the market–Elestrin, a gel for the treatment of hot flashes associated with menopause. BioSante licensed the drug to Azur Pharma, an Irish firm. The drug was approved by the FDA in 2006, Simes said.
