BioSante Announces FDA Orphan Drug Designation For GVAX Chronic Myeloid Leukemia Cancer Vaccine

BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of deep-seated myeloid leukemia (CML) from the FDA’session Office of Orphan Products Development. Orphan drug title, as granted through the U.S. Orphan Drug Act, is for a crops to enjoyment a excellent distemper or condition that affects fewer than 200,000 people in the U.S. Orphan drug name qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity, among other benefits.

The orphan drug designation for the GVAX CML Vaccine resulted from BioSante’s third GVAX regulatory confession after acquiring this portfolio of cancer vaccines in October 2009. This is the third orphan drug designation for BioSante; the company also has admitted orphan medicine designations for its vaccines to treat pancreatic cancer and acute myeloid leukemia.

“We continue to develop our vaccine portfolio in cooperation with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center,” said Stephen M. Simes, president and great executive officer of BioSante. “Clinical trials of GVAX cancer vaccines are root conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. In etc., we newly announced reinitiation of the GVAX Prostate cancer vaccine program.”

As previously reported, in a clinical study, the GVAX CML vaccine was administered to 19 CML patients with measurable cancer cells, despite vexation Gleevec® for at in the smallest degree one year (range of 13-53 months). Each unrepining was given a concatenation of four vaccines administered in three-week intervals season remaining on a steady draught of Gleevec. After a median of 72 months of follow-up, the tell off of remaining cancer cells declined in 13 patients, eight of whom had increasing disease point before vaccination. Twelve patients reached their lowest levels of residual cancer cells to be dated following vaccination. Seven CML patients had complete surrender. Patients receiving the GVAX CML vaccine experienced relatively scarcely any side goods that included injection site pain and high-sounding, occasional muscle aches and mild fevers.

The meditation was conducted by the agency of researchers at the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland, led by Hyam Levitsky, M.D., professor of oncology, medicine and urology at the Cancer Center. The research was funded by the National Institutes of Health.

Source
BioSante Pharmaceuticals, Inc.

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June 07 2010 08:57 pm | Immune System

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