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-201

for Patients Enrolled in Triple Negative Breast Cancer Trial

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.