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BiPar Sciences Expands Clinical Development of BSI-201, A Novel PARP Inhibitor, With Phase 2 Trial in Uterine Cancer
Date:5/28/2008

- Strategic Collaboration with the Gynecologic Oncology Group -

BRISBANE, Calif., May 28 /PRNewswire/ -- BiPar Sciences, Inc. today announced it has expanded its clinical trials program through the initiation of an additional Phase 2 study of its lead product candidate BSI-201. The trial will assess BSI-201, the first ADP-ribose polymerase (PARP) inhibitor in the company's DNA repair portfolio, for the treatment of uterine carcinosarcoma or malignant mixed mullerian tumors.

This multi-center, open-label, single-arm study in patients with recurrent or advanced uterine carcinosarcomas will evaluate BSI-201 in combination with standard treatment and is being conducted by the Gynecologic Oncology Group, a National Cancer Institute-funded research organization which focuses on gynecologic malignancies. The primary objective of this trial is to determine the antitumor activity of BSI-201 plus carboplatin/paclitaxel in patients with recurrent or advanced uterine carcinosarcomas.

The identification of mixed mullerian tumors of the uterus as a target for its PARP inhibitor was the result of BiPar's ground-breaking work that assessed PARP1 gene expression across all types of human cancers. Striking up- regulation of the PARP gene was a characteristic of cancer of female reproductive organs -- breast, ovary and uterus. PARP over-expression was particularly intense in uterine mixed mullerian tumors, a cancer for which there is no well established standard, effective treatment. BSI-201 blocks a pathway by which tumor cells resist the effects of DNA damaging chemotherapy. Therefore BSI-201 may work to potentiate the effects of current therapies for uterine cancer.

"Current treatments for uterine carcinosarcoma remain limited and are often poorly tolerated," said Carol Aghajanian, M.D., chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center and the Study Chair for this Gynecologic Oncology Group investigatio
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SOURCE BiPar Sciences, Inc.
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