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Ascenta Therapeutics Announces Presentation of Promising Results From Clinical Trials of AT-101 in Prostate, Brain, and Lung Cancers at 2009 ASCO Annual Meeting
Date:6/1/2009

so presented(3) . Fifty-six patients were enrolled with daily oral doses of AT-101 given for 21 of 28 days in repeated cycles. The treatment was well tolerated, with a low incidence of serious adverse events and no unique central nervous system toxicities. Responses were evaluated in 43 patients and included one confirmed partial response and 8 patients with stable disease, representing half of the patients still alive at the time of analysis. Progression-free survival (PFS) in these patients ranged from 8 to 13 months. Determination of the impact of AT-101 on overall survival (OS), the primary endpoint, is ongoing.

AT-101 in Lung Cancer

Reports from two studies in lung cancer also showed promising signals of antitumor effect. The first presentation described results from a randomized, double-blind, placebo-controlled Phase II trial in 105 patients who had received one prior chemotherapy regimen for non-small cell lung cancer (NSCLC)(4). While the primary endpoint, a statistically significant improvement in PFS, was not met, the docetaxel plus AT-101 arm demonstrated a positive trend in OS, as reflected in the Kaplan-Meier curves (hazard ratio 0.82). This group also demonstrated a 33 percent increase in median survival and a 34 percent increase in 6-month survival compared to the docetaxel plus placebo arm. Common adverse events included fatigue (18 percent), anemia (18 percent) and dyspnea (18 percent). Using NSCLC cell lines, a genomic profile predicting response to AT-101 was developed in collaboration with Duke University. Opportunities to validate this biomarker will be pursued in future trials.

The second presentation reported on an open-label, Phase I/II study of AT-101 in combination with topotecan in patients with relapsed or refractory small cell lung cancer (SCLC) who had received prior platinum-based first line chemotherapy(5). The Phase II portion of the trial included 25 patients div
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