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BiPar Sciences, Inc. today announced it has initiated a Phase 2 study of its lead PARP inhibitor, BSI-201, in patients with triple-negative breast cancer that do not express the estrogen, progesterone or HER2 receptors
BRUSSELS, Belgium and BRISBANE, CA, USA | November 15, 2007 | BiPar Sciences, Inc., a privately held biopharmaceutical company developing novel cancer therapies, today announced it has initiated a Phase 2 study of its lead PARP inhibitor, BSI-201, in patients with triple-negative breast cancer that do not express the estrogen, progesterone or HER2 receptors.
The company designed the Phase 2 trial in this indication-which represents a major unmet medical need-based on molecular biomarker data presented today showing that breast tumors that are estrogen-negative and progesterone- negative were more likely to overexpress PARP, as were HER2-negative tumors. The data were presented at European Organization for Research and Treatment of Cancer-National Cancer Institute-American Society for Clinical Oncology Annual Meeting on "Molecular Markers in Cancer" in Brussels.
"Our research shows clearly that not only is PARP overexpressed in breast tumors generally, it is even more likely to be overexpressed in triple- negative tumors. That suggests that PARP inhibition may be a particularly effective way to target those hard-to-treat cancers," said BiPar Executive Vice President Barry Sherman, M.D. "Our Phase 2 trial of BSI-201 will build on those insights and, if successful, will serve as powerful proof of our strategy to use molecular biomarker data to focus our clinical studies of BiPar's PARP inhibitors on tumors that markedly upregulate PARP."
Patients with triple-negative breast cancer, who make up 10 to 15 percent of all patients, have few effective therapeutic options. Neither targeted therapies such as Herceptin and Tykerb nor anti-estrogens such as tamoxifen provide a benefit, and triple-negative tumors are associated with a high rate of relapse. Such cancers are particularly prevalent in premenopausal African- American women.
"We are very excited about being able to offer patients with triple- negative metastatic breast cancer treatment with the PARP inhibitor BSI-201," said Joyce O'Shaughnessy, M.D., lead investigator, Texas Oncology, PA, Baylor-Sammons Cancer Center in Dallas, US Oncology, and co-chair of the breast cancer research committee of the US Oncology Research Network. "There is a compelling need for a novel approach to treating this high-risk population."
The Phase 2 trial of BSI-201 in patients with triple-negative breast cancer will enroll 120 women in a multicenter, randomized, open-label trial that will compare standard chemotherapy with or without the addition of BSI- 201.
The research presented in Brussels showed the results of an analysis of PARP gene expression in 169 infiltrating ductal breast cancers through the use of the Gene Logic Inc. (Nasdaq: GLGC) BioExpress(R) System database. PARP expression was above the 99.9 percent upper confidence limit for normal tissue in 45 percent of all breast tumors, compared with 75 percent of breast tumors that were estrogen-negative and progesterone-negative and 90 percent of HER2- negative patients.
PARP is a well-characterized and validated target for cancer therapies. PARP plays a central role in cell proliferation in DNA repair, and the PARP-1 gene is upregulated in certain tumor types.
BiPar's novel, proprietary PARP inhibitors are a new generation of drug candidates that show promising activity and a favorable toxicity profile. Preclinical and early clinical studies suggest the drugs selectively induce tumor cell death and are active against a broad range of tumor types. In addition to the trial in patients with triple-negative breast cancer, BiPar plans to begin a series Phase1b and Phase 2 trials of BSI-201 in other major cancers that overexpress PARP over the next several months.
About BiPar Sciences
BiPar Sciences Inc. (http://www.biparsciences.com) is a clinical-stage biopharmaceutical company developing and commercializing a pipeline of novel, tumor-selective drugs designed to meet the significant unmet needs of cancer patients.
About the US Oncology Research Network
The US Oncology Research Network is an established community-based research operation specializing in all phases of cancer clinical trials. The research network currently has more than 536 physicians actively enrolling patients, 88 research sites, and is currently involved in 72 open research trials. The network has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the Food and Drug Administration for use. Since 1993, nearly 30,000 patients have participated in clinical trials managed by US Oncology network practices. For more information, visit the "Research" section under "Our Services" on the company's Web site, http://www.usoncology.com.
SOURCE: BiPar Sciences, Inc. |
