BiPar Sciences Begins Enrollment in Phase 1b Study of BSI-201
- Category: Small Molecules
- Published on Friday, 05 January 2007 02:00
- Hits: 2353
BRISBANE, CA, USA | Jan 04, 2007 | BiPar Sciences, Inc., a privately held biopharmaceutical company developing novel cancer therapies, announced today that enrollment has begun in its Phase 1b study of BSI-201. The trial will assess the effects of BSI-201, in combination with one of four different cytotoxic regimens, in patients with solid tumors.
BSI-201 is BiPar's lead compound in a new class of cancer therapies known as PARP (poly-ADP-ribose polymerase) inhibitors and has been shown in preclinical studies to selectively induce tumor cell death. Preclinical studies suggest the drug is well tolerated and active against a broad range of tumor types.
"The knowledge gained from this new combination Phase 1b study, from our ongoing monotherapy Phase 1 study and from our proprietary genomic data will set the stage for a robust BSI-201 Phase 2 program," said Thomas F. White, BiPar's president and chief executive officer. "Less than two years after our initial financing, BiPar is well positioned with two clinical studies in progress for BSI-201 and two promising pre-clinical programs moving forward rapidly."
The four-arm Phase 1b study is being conducted at three clinical sites: Fox Chase Cancer Center in Philadelphia, the Institute for Drug Development in San Antonio (IDD) and the Barbara Ann Karmanos Cancer Institute in Detroit. "We are excited to participate in the early clinical development of this interesting PARP inhibitor and to enroll the first patient in a Phase 1b study, which will generate data on the potential efficacy of BSI-201 when given in combination with various chemotherapeutic regimens," said Anthony Tolcher, M.D., Director of Clinical Research at IDD.
The company began its clinical program last year, assessing BSI-201 as monotherapy in an open-label, escalating-dose Phase 1 trial designed to confirm safety of the drug in patients and establish a maximum tolerated dose and pharmacokinetic profile. That study, enrolling patients with solid tumors and being conducted at M.D. Anderson Cancer Center in Houston and IDD, is ongoing.
About BiPar Sciences
BiPar Sciences, Inc. (www.biparsciences.com ) is a clinical-stage biopharmaceutical company developing and commercializing a novel class of tumor-selective drugs designed to meet the significant unmet needs of cancer patients. The Company's lead product candidate is BSI-201, which is now in early-stage clinical testing for advanced malignancies. The Company will be evaluating the potential of BSI-201 in multiple cancers and expects to file investigational new drug applications on as many as two additional cancer drug candidates in 2007.