BiPar Sciences Expands Clinical Program for BSI-201, a Novel DNA Repair Inhibitor,...

BiPar Sciences Expands Clinical Program for BSI-201, a Novel DNA Repair
Inhibitor, in Brain Cancer
- Strategic Collaboration with the National Cancer Institute's NABTT
Consortium -

BRISBANE, Calif., April 10 /PRNewswire/ -- BiPar Sciences, Inc. today
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.
SOURCE BiPar Sciences, Inc.

Eric Malek, Vice President, Corporate Development of BiPar Sciences, Inc.,
+1-650-635-0165, emalek@biparsciences.com; or Stacie D. Byers of WeissComm
Partners, +1-415-946-1072, sdbyars@wcpglobal.com, for BiPar Sciences, Inc.