BiPar Sciences Expands Clinical Program For BSI-201, A Novel DNA Repair Inhibitor, In Brain Cancer

Main Category: Neurology / Neuroscience
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 11 Apr 2008 - 0:00 PST

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BiPar Sciences, Inc. announced the expansion of the clinical program for the company's lead product candidate, BSI-201, into glioblastoma multiforme (GBM), the most common glioma in adults. BSI-201, the first poly ADP-ribose polymerase (PARP) inhibitor in BiPar's DNA repair portfolio, crosses the blood-brain barrier, a unique property that enables its targeted investigation in the brain tumor setting. This study is being conducted by investigators from the New Approaches to Brain Tumor Therapy (NABTT) consortium, a National Cancer Institute-funded research group. In addition to GBM, BiPar is currently enrolling BSI-201 in a randomized Phase 2 trial for triple-negative breast cancer and is initiating Phase 2 trials in uterine and BRCA-negative ovarian cancers.

"We believe a multi-drug strategy is the best approach to battling GBM. There is a significant need for new treatments that can offer GBM patients and their families additional hope," said Stuart A. Grossman, M.D., professor of oncology, medicine and neurological surgery at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital and the co-chairperson for this study.

"BSI-201 is a promising agent that has been well tolerated in combination with cytotoxic therapies in patients with solid tumors and potentially addresses a key pathway by which GBM cells resist the effects of existing medications. We are hopeful that BSI-201 will safely potentiate the power of current therapies for GBM and improve survival in this difficult-to-treat cancer," said Jaishri Blakeley, M.D., Assistant Professor of Neurology, Oncology and Neurosurgery at Johns Hopkins and the study chairperson for this study.

"The scientific observations that BSI-201 crosses the blood-brain barrier and has a mechanistic basis to synergize with the standard treatment of GBM makes this a promising study," said BiPar Executive Vice President Barry Sherman, M.D. "It is the promise of this approach that encouraged the leaders of NABTT to evaluate BSI-201 in patients with GBM."

GBM is an aggressive form of brain cancer that strikes 10,000 patients a year in the United States. Currently, patients are often treated with radiotherapy and chemotherapy where the median survival is under 15 months. The initial study phase will evaluate the safety and tolerability of BSI-201 in combination with temozolomide given at standard doses. The Phase 2 component will assess BSI-201 combined with temozolomide plus radiation therapy in newly diagnosed GBM patients, where the primary endpoint is overall survival.

Additional Data to be Presented at Upcoming AACR 2008 Meeting

BiPar will present preclinical data on BSI-201 at the American Association for Cancer Research (AACR) Annual Meeting in San Diego on Monday, April 14, 2008. The abstract, "Activity of BSI-201, a potent poly (ADP-ribose) polymerase (PARP) inhibitor, alone and in combination with topotecan in human ovarian xenografts," will be presented at 8 a.m. in the "New Agents and Therapeutic Approaches" session.

About BiPar Sciences

BiPar Sciences is a drug development company with a therapeutic focus on novel mechanisms of action in oncology. Our existing platform is based on DNA repair, specifically with poly ADP-ribose polymerase (PARP) inhibitors. BSI-201 is the lead PARP inhibitor program in Phase 2 clinical trials in multiple solid tumor settings.

BiPar Sciences, Inc.
http://www.biparsciences.com