Angiogenix Announces Phase II Data for Acclaim

Angiogenix has announced results from the recently completed Phase II clinical trial for Acclaim, its product candidate for the prevention of nitrate tolerance in chronic stable angina patients.

Results demonstrated that Acclaim was safe and well-tolerated. Acclaim, the first proprietary oral nitrate therapy in over a decade, did not meet its primary endpoint of increased treadmill walking time (TWT) with statistical significance, the company said. However, the analysis of the data revealed positive, nonstatistically significant trends for patients treated with Acclaim regarding time to onset of angina and ST-segment depression.

Also, there was a trend toward benefit in those patients receiving concomitant ACE inhibitor therapy. Patients in the study were randomized to receive either Acclaim, a proprietary combination of isosorbide mononitrate plus L-arginine, or conventional standard of care -- nitrate alone therapy. Both groups were tested against the primary endpoint of TWT until moderate angina occurred.

Secondary endpoints included time to ST-segment depression and time to first onset of angina. Other endpoints included the need for rescue medication and number of anginal episodes.