Ascenta Therapeutics Announces Presentation of Promising Results From Clinical Trials of AT-101 in Prostate, Brain, and Lung Cancers at 2009 ASCO Annu...(AT-101 was well tolerated in this combin...)

Date:6/1/2009

AT-101 was well tolerated in this combination as the majority of adverse events were Grade 1 or 2. Serious adverse events occurred in only 16 patients but there were no notable differences in the rates or severities of fatigue, gastrointestinal toxicities, or cytopenia compared to those generally associated with docetaxel/prednisone alone.

"The initial response rates we are seeing in this trial demonstrate strong evidence of antitumor activity in patients with metastatic CRPC," said Gary R. MacVicar, MD, Northwestern University's Feinberg School of Medicine. "Our data suggest that adding AT-101 to docetaxel/prednisone may improve clinical outcomes, without incremental toxicity, and we look forward to confirming this in larger studies."

Complementing these findings from the chemotherapy-naive setting, another presentation reported data from a cohort of men with docetaxel-refractory prostate cancer who were treated with the same docectaxel/prednisone/AT-101 regimen(2). A rigorous definition of refractory was used in this trial, as the 38 patients had to have had documented disease progression during prior therapy with a docetaxel-containing regimen to qualify for enrollment. In this analysis, 41 percent of patients had a 30 percent reduction in PSA and 22 percent achieved a PSA partial response. In the group with measurable disease, 24 percent of patients achieved a partial response per RECIST. The regimen was also well tolerated, with rates and severity of toxicity comparable to those associated with the standard docetaxel/prednisone therapy. Only one reported serious adverse event, a case of small bowel obstruction (Grade 2), was considered potentially treatment-related.

AT-101 in Brain Cancer

Preliminary results from a National Cancer Institute (NCI) sponsored Phase II study of AT-101 as monotherapy for recurrent glioblastoma multiforme (GBM), the most aggressive form of brain cancer, were al
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