Ascenta Therapeutics Announces Presentation of Results From a Dose-Ranging Study of AT-101 With Standard Therapy in Patients With Glioblastoma Multiforme

October 26, 2009

MALVERN, Pa., Oct. 26 /PRNewswire/ -- Ascenta Therapeutics announced today that encouraging results from a Phase I dose-escalation study of two combination therapy regimens containing AT-101, an oral, pan-Bcl-2 inhibitor, in patients with the most malignant type of brain tumor, were described in an oral presentation at the 2009 Joint Meeting of the Society for NeuroOncology (SNO) and AANS/CNS Section on Tumors in New Orleans, Louisiana (Concurrent Session VI: Radiation Oncology, October 23, 2009; Abstract # 449).

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The study, conducted through the Adult Brain Tumor Consortium (ABTC), formerly the New Approaches to Brain Tumor Therapy (NABTT) consortium, enrolled 16 patients with newly diagnosed glioblastoma multiforme who received either AT-101 administered concurrently with temozolomide and radiation therapy (Arm 1) or AT-101 as a component of temozolomide adjuvant therapy after chemoradiation (Arm 2). At the time of analysis, six of the 16 patients remained alive, with median survival times of 15.1 months and 18.1 months for Arm 1 and Arm 2 respectively.

"The combination treatment was very well tolerated and the preliminary overall survival rates are encouraging," said John B. Fiveash, MD, Associate Professor, Department of Radiation Oncology, University of Alabama at Birmingham, the principal investigator. "Our results suggest that AT-101 used in combination with temozolomide and radiation therapy may help extend the lives of patients with this very aggressive form of brain cancer and deserves further study."

The investigators concluded that AT-101 can be administered safely with radiation therapy and temozolomide in patients with newly diagnosed glioblastoma multiforme, exhibiting a toxicity profile similar to that observed with AT-101 in the treatment of other tumor types. They also determined the recommended dose of AT-101 in both combination regimens for future studies.

"These data complement preliminary encouraging survival signals from a National Cancer Institute (NCI) Phase 2 study of AT-101 monotherapy in glioblastoma multiforme presented earlier this year at the American Society of Clinical Oncology (ASCO)," said Mel Sorensen, MD, CEO of Ascenta Therapeutics.

About Glioblastoma Multiforme

Gliobastoma multiforme, the tumor type that recently claimed the life of U.S. Senator Edward M. Kennedy, is the most common and malignant form of brain cancer. With an estimated incidence of 2-3 new cases for every 100,000 Americans each year, glioblastoma multiforme represents approximately 60 percent of the 17,000 primary brain tumors or gliomas diagnosed annually. Glioblastoma multiforme is particularly aggressive and is almost uniformly fatal within 3 months without treatment. Median survival for patients receiving current optimal therapy (tumor resection followed by radiation and chemotherapy) is 12 months. In this setting, only about 25 percent of patients with glioblastoma multiforme will survive for two years beyond diagnosis, a number that drops to approximately 10 percent at five years. Treatment approaches that extend survival for patients with glioblastoma multiforme represent an urgent unmet need in oncology.

About AT-101

AT-101 is an orally-active, pan-Bcl-2 inhibitor (including Bcl-2, Bcl-xL, Bcl-w, and Mcl-1 inhibition) that has been shown to induce apoptosis (programmed cell death) directly by operating as a BH3 mimetic and indirectly as an independent upregulator of Noxa and Puma. By blocking the binding of Bcl-2 family members with proapoptotic proteins and upregulating specific proapoptotic factors, AT-101 lowers the threshold for cancer cells to undergo apoptosis in various tumor types.

About Ascenta Therapeutics

Ascenta Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company that discovers and develops new medicines for the treatment of cancer. The company is headquartered in Malvern, Pennsylvania, and has a preclinical research facility in Shanghai, China. Its technology, licensed from both the National Institutes of Health and the laboratory of Dr. Shaomeng Wang at the University of Michigan, is focused on discovering molecules that restore the natural potential for cancer cells to undergo cell death (apoptosis). Ascenta's lead agent, AT-101, is an orally-active small molecule pan Bcl-2 inhibitor (Bcl-2, Bcl-xL, and Mcl-1) being studied in several tumor types, including ongoing Phase 2 clinical trials in castrate resistant prostate cancer. The Company's development pipeline also includes the oral multi-IAP antagonist AT-406, which has just entered human clinical evaluation, and a preclinical HDM2-p53 inhibitor program.

For additional information on Ascenta Therapeutics, please visit the company's website at www.ascenta.com

SOURCE Ascenta Therapeutics, Inc.