NewsRx.com
June 5, 2008
BiPar Sciences, Inc. announced it has expanded its clinical trials program through the initiation of an additional Phase 2 study of its lead product candidate BSI-201. The trial will assess BSI-201, the first ADP-ribose polymerase (PARP) inhibitor in the company's DNA repair portfolio, for the treatment of uterine carcinosarcoma or malignant mixed mullerian tumors.
This multi-center, open-label, single-arm study in patients with recurrent or advanced uterine carcinosarcomas will evaluate BSI-201 in combination with standard treatment and is being conducted by the Gynecologic Oncology Group, a National Cancer Institute-funded research organization which focuses on gynecologic malignancies. The primary objective of this trial is to determine the antitumor activity of BSI-201 plus carboplatin/paclitaxel in patients with recurrent or advanced uterine carcinosarcomas.
The identification of mixed mullerian tumors of the uterus as a target for its PARP inhibitor was the result of BiPar's ground-breaking work that assessed PARP1 gene expression across all types of human cancers. Striking up- regulation of the PARP gene was a characteristic of cancer of female reproductive organs -- breast, ovary and uterus. PARP over-expression was particularly intense in uterine mixed mullerian tumors, a cancer for which there is no well established standard, effective treatment. BSI-201 blocks a pathway by which tumor cells resist the effects of DNA damaging chemotherapy. Therefore BSI-201 may work to potentiate the effects of current therapies for uterine cancer.
"Current treatments for uterine carcinosarcoma remain limited and are often poorly tolerated," said Carol Aghajanian, M.D., chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center and the Study Chair for this Gynecologic Oncology Group investigation. "The combination of a PARP inhibitor such as BSI-201 which specifically targets uterine tumors in a unique way may boost the effects of common chemotherapy regimen. We hope this drug will play a transformative role in the way we approach treatment."
Uterine cancer is the most common gynecological tumor, and the fourth most-common type of tumor in women. Forty thousand new diagnoses are made each year in the United States.
"Because PARP is expressed at high levels in uterine cancer and particularly MMT, we believe that BSI-201 has the potential to selectively target these highly aggressive and poorly treated tumors," said BiPar Executive Vice President Barry Sherman, M.D. "This will be our third study designed around our gene expression data, which has been invaluable in selecting types of cancer that will most likely respond to PARP inhibition."
Copyright 2008, Clinical Trials Week via NewsRx.com
