Navigation Links
BiPar Begins Phase 2 Study of Lead PARP Inhibitor in Triple-Negative Breast Cancer Based on Overexpression Biomarker Data

BRUSSELS, Belgium and BRISBANE, Calif., Nov. 15 /PRNewswire/ -- 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. ( 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,

SOURCE BiPar Sciences, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. BiPar Expands Management Team to Advance Lead PARP Inhibitor Product Candidate Into Phase 2 Trials for Cancer
2. BiPar Announces Preclinical Data Demonstrating Anti-Tumor Activity With BSI-401, Its Second-Generation PARP Inhibitor
3. BiPar Genomic Biomarker Data Demonstrate Overexpression of PARP-1 Gene in Multiple Cancer Types
4. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
5. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
6. Enrollment Begins on Human PK Study for Medidur(TM) FA
7. Vical Begins Phase 1 Trial of DNA Vaccine Against H5N1 Pandemic Influenza
8. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
9. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
10. Metabolex Begins Phase 2 Trial of MBX-8025 for Treatment of Dyslipidemia
11. DiObex Begins Dosing Patients in Phase 2b Trial of Type 2 Diabetes Drug
Post Your Comments:
(Date:11/25/2015)... 2015 AAIPharma Services Corp./Cambridge Major Laboratories, ... least $15.8  Million to expand its laboratories and ... . The expansion will provide additional office space ... demands of the pharmaceutical and biotechnology markets. ... provide up to 40,000 square feet of expanded ...
(Date:11/25/2015)... , Nov. 25, 2015  ARKRAY USA ... continues to provide evidence demonstrating the accuracy of its ... Congress on Insulin Resistance, Diabetes and Cardiovascular Disease in ... both the Company,s GLUCOCARD ® 01 meter and ... accuracy requirements. The ability to accurately measure glucose levels ...
(Date:11/25/2015)... 25, 2015 Kitov Pharma ... KTOV), a biopharmaceutical company focused on the development of ... conditions, today announced the closing of its previously announced ... ADSs ), each representing 20 ordinary shares of the ... The ADSs and warrants were issued in a fixed ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... The moment you stop improving is the ... the needs of advisers and clients but going above and beyond to find ... service. However, there's always room for improvement, which is why the entire Consulting ...
(Date:11/27/2015)... ... 2015 , ... CBD College is proud to announce that on ... accreditation to its Diagnostic Medical Sonography program. CBD College is honored to join this ... colleges and universities in the state of California make the cut. CBD College is ...
(Date:11/27/2015)... ... 2015 , ... Dr. Thomas Dunlap and Dr. Patrick Coleman ... with Emergency Medicine at St., Joseph Health System’s Santa Rosa Memorial Hospital , ... in similar ways and require time-critical intervention to avoid large area heart damage and ...
(Date:11/27/2015)... ... ... Indosoft Inc., developer and distributor of the world-class Asterisk ... Term Support) into its Q-Suite 5.10 product line. , Making the change to ... of Asterisk that will receive not only security fixes, but feature and bug ...
(Date:11/26/2015)... ... 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday sales ... Black Friday and Cyber Monday massage chair sales to receive the best ... low to find the best massage chair deals, they can see all of the ...
Breaking Medicine News(10 mins):