Results from Phase I dose-escalation study of AT-101 announced

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).

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.