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Alnylam announces results from ALN-VSP Phase I study on liver cancers

Published on June 5, 2012 at 2:28 AM · No Comments

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced results today from its Phase I extension study with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement. The data are being presented in a poster titled "Open-Label Extension Study of the RNAi Therapeutic ALN-VSP02 in Cancer Patients Responding to Therapy," in the Development Therapeutics - Experimental Therapeutics poster session being held Monday, June 4, 2012 from 8:00 a.m. to 12:00 p.m. CDT. Overall, the results demonstrated disease control lasting more than six months in the majority of patients treated on the extension study, including a complete response (CR) in an endometrial cancer patient who had multiple liver metastases. In this study, chronic dosing of up to 23 months with ALN-VSP was found to be generally safe and well tolerated.    

"We are very encouraged with the continued positive data from our ALN-VSP Phase I clinical trial and extension study. These data include safety and tolerability of multiple doses of ALN-VSP, as well as evidence for anti-tumor activity in this very advanced, heavily pre-treated cancer patient population. We have seen multiple patients achieve stable disease or better, including a patient with endometrial cancer metastatic to the liver who has achieved a complete response," said Jared Gollob, M.D., Senior Director of Clinical Research at Alnylam. "Results from the extension study also give us increased confidence in long-term chronic dosing with RNAi therapeutics delivered via LNPs, as patients have received drug twice a month for up to nearly two years, and approximately 11 months on average. We look forward to partnering this program to further advance the clinical development of ALN-VSP as we believe the evidence of anti-tumor activity warrants Phase II testing."

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