Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that it has completed enrollment in its ALN-VSP Phase I multi-center, multinational, open label, dose escalation clinical trial. The study's objectives were to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors with liver involvement. ALN-VSP was administered to over 40 patients at doses ranging from 0.1 to 1.5 mg/kg, with multiple patients continuing to receive therapy on the study. Alnylam will present data from its ALN-VSP program at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3 - 7, 2011.
"We are pleased to have completed enrollment in our Phase I trial with ALN-VSP," said Jared Gollob, M.D., Senior Director, Clinical Research at Alnylam. "The data from this program have been encouraging to date, and the results are important not only for the continued advancement of ALN-VSP toward Phase II studies but also for the overall advancement of systemically delivered RNAi therapeutics. We will be presenting updated data from this Phase I trial at the ASCO Annual Meeting in June."
"Both primary liver cancer and metastatic disease of the liver are associated with poor prognosis for patients, and new therapies are clearly needed," said Josep Tabernero, M.D., Chairman of the Medical Oncology Department and Phase I Program at Vall d'Hebron University Hospital in Barcelona, Spain. "This study represents an important step in the development of a novel therapeutic strategy to treat this devastating disease, and we look forward to evaluating the full data from this trial."
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