BiPar Sciences presents interim phase 2 results for PARP inhibitor BSI-201 at San Antonio Breast Cancer Symposium

Abstract

Results Demonstrate Continued Safety of Cancer Drug BSI-201for Patients Enrolled in Triple Negative Breast Cancer TrialBRISBANE, 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 2clinical trial of the company's PARP inhibitor, BSI-201, in combinationwith chemotherapy in patients with triple negative metastatic breastcancer (TNBC). The company also presented gene expression data thatconfirmed significant upregulation of PARP in the tumors of the first50 patients enrolled in the Phase 2 trial. Results were presented in aposter 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," saidHoyoung Huh, M.D., Ph.D., president and chief executive officer ofBiPar Sciences. "Our PARP inhibitor appears to be well tolerated, andour findings show that PARP is an important target in solid tumorsincluding TNBC. We look forward to reporting Phase 2 efficacy data forthis 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 duringthe SABCS's second poster session on Friday, December 12, 2008. Theposter illustrated data from the Phase 2 trial of BSI-201 in metastaticbreast cancer patients whose tumors were negative for three commonbreast cancer markers: estrogen receptor, progesterone receptor, andHER2. The trial participants were randomized into two different trialarms; one group who received chemotherapy (G/C) alone and one group whohad 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 oftherapy. The frequency and nature of reported adverse events did notdiffer between the two trial arms, and no added toxicities wereattributable to BSI-201. In addition, gene expression profiling fromthe first 50 patients enrolled confirmed that the patients' tumors hadsignificant 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 particularlyaggressive and more likely to recur than other types of breast cancer,"said Barry Sherman, M.D., executive vice president of development, atBiPar Sciences. "TNBC comprises 15 to 20 percent of all breast cancersand disproportionately affects younger and African-American women. TNBCcurrently does not have an approved standard treatment regimen andrepresents a significant unmet medical need. Our goal is to completethe BSI-201 Phase 2 trial as quickly as possible and move forward withthe development of this promising compound."About SABCSThe CTRC-AACR San Antonio Breast Cancer Symposium is the largest annualsymposium in the world devoted to breast cancer research and physicianeducation. The symposium provides an important venue for cancer expertsto review the latest information on experimental biology, etiology,prevention, diagnosis and therapy of breast cancer and premalignantdisease. This year's program includes lectures and mini-symposia byexperts in clinical and basic research. More than 1,000 slide andposter presentations were selected from submitted abstracts and casediscussions.About BiPar Sciences and BSI-201BiPar Sciences, Inc. is a clinical-stage biopharmaceutical companydeveloping and commercializing a novel class of tumor-selective drugsdesigned to address unmet needs of cancer patients. The company's leadproduct candidate is BSI-201, which is in Phase 2 testing for triplenegative breast cancer, ovarian cancer and other malignancies. BSI-201is a PARP inhibitor and represents a targeted approach to treatingsolid tumors. Studies have shown that these inhibitors prevent cancercells from repairing damaged DNA, ultimately causing them to die. Thecompany is also conducting preclinical studies on two additionalcompounds, 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 areroutinely tested for and classified based on the presence of estrogen,progesterone, and HER2 receptors. Commonly used breast cancertherapies, such as tamoxifen and Herceptin(r), target these receptors.However, up to 20 percent of all breast cancers are negative for allthree receptors, thus giving rise to the term "triple negative breastcancer (TNBC)."TNBC is a difficult-to-treat cancer subtype that does not have anapproved standard-of-care and does not respond to current hormone-basedand targeted therapies. TNBC is a very aggressive cancer, with higherrates of metastases and poorer survival rates than other breast cancersubtypes. The prevalence of the TNBC subtype is higher in younger andAfrican-American women.