BRISBANE, Calif., Dec. 12, 2008 (GLOBE NEWSWIRE) -- BiPar Sciences, Inc., a privately held biopharmaceutical company developing poly (ADP-ribose) polymerase (PARP) inhibitors as novel cancer therapies, today announced positive interim safety data from an ongoing Phase 2 clinical trial of the company's PARP inhibitor, BSI-201, in combination with chemotherapy in patients with triple negative metastatic breast cancer (TNBC). The company also presented gene expression data that confirmed significant upregulation of PARP in the tumors of the first 50 patients enrolled in the Phase 2 trial. Results were presented in a poster at the 2008 annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.
"We are very encouraged by the results of BSI-201 to date," said Hoyoung Huh, M.D., Ph.D., president and chief executive officer of BiPar Sciences. "Our PARP inhibitor appears to be well tolerated, and our findings show that PARP is an important target in solid tumors including TNBC. We look forward to reporting Phase 2 efficacy data for this trial in mid-2009."
The poster titled "Triple Negative Metastatic Breast Cancer: A Phase 2, Multi-Center, Open-Label, Randomized Trial of Gemcitabine/Carboplatin (G/C) With or Without BSI-201, a PARP Inhibitor" was presented during the SABCS's second poster session on Friday, December 12, 2008. The poster illustrated data from the Phase 2 trial of BSI-201 in metastatic breast cancer patients whose tumors were negative for three common breast cancer markers: estrogen receptor, progesterone receptor, and HER2. The trial participants were randomized into two different trial arms; one group who received chemotherapy (G/C) alone and one group who had BSI-201 added to their G/C regimen. The 89 clinical trial subjects (out of a targeted 120 patients) were treated for up to 12 cycles of therapy. The frequency and nature of reported adverse events did not differ between the two trial arms, and no added toxicities were attributable to BSI-201. In addition, gene expression profiling from the first 50 patients enrolled confirmed that the patients' tumors had significant upregulation of PARP, compared with normal breast tissue, supporting the targeting of this enzyme with BSI-201.
"TNBC is a very difficult-to-treat cancer subtype that is particularly aggressive and more likely to recur than other types of breast cancer," said Barry Sherman, M.D., executive vice president of development, at BiPar Sciences. "TNBC comprises 15 to 20 percent of all breast cancers and disproportionately affects younger and African-American women. TNBC currently does not have an approved standard treatment regimen and represents a significant unmet medical need. Our goal is to complete the BSI-201 Phase 2 trial as quickly as possible and move forward with the development of this promising compound."
About SABCS
The CTRC-AACR San Antonio Breast Cancer Symposium is the largest annual symposium in the world devoted to breast cancer research and physician education. The symposium provides an important venue for cancer experts to review the latest information on experimental biology, etiology, prevention, diagnosis and therapy of breast cancer and premalignant disease. This year's program includes lectures and mini-symposia by experts in clinical and basic research. More than 1,000 slide and poster presentations were selected from submitted abstracts and case discussions.
About BiPar Sciences and BSI-201
BiPar Sciences, Inc. is a clinical-stage biopharmaceutical company developing and commercializing a novel class of tumor-selective drugs designed to address unmet needs of cancer patients. The company's lead product candidate is BSI-201, which is in Phase 2 testing for triple negative breast cancer, ovarian cancer and other malignancies. BSI-201 is a PARP inhibitor and represents a targeted approach to treating solid tumors. Studies have shown that these inhibitors prevent cancer cells from repairing damaged DNA, ultimately causing them to die. The company is also conducting preclinical studies on two additional compounds, BSI-401 (PARP inhibitor) and BSI-302 (anti-tubulin program). BiPar Sciences is privately held with headquarters in Brisbane, California. For more information, please visit www.biparsciences.com.
About Triple Negative Breast Cancer (TNBC)
When patients are diagnosed with breast cancer, their tumors are routinely tested for and classified based on the presence of estrogen, progesterone, and HER2 receptors. Commonly used breast cancer therapies, such as tamoxifen and Herceptin(r), target these receptors. However, up to 20 percent of all breast cancers are negative for all three receptors, thus giving rise to the term "triple negative breast cancer (TNBC)."
TNBC is a difficult-to-treat cancer subtype that does not have an approved standard-of-care and does not respond to current hormone-based and targeted therapies. TNBC is a very aggressive cancer, with higher rates of metastases and poorer survival rates than other breast cancer subtypes. The prevalence of the TNBC subtype is higher in younger and African-American women.