Singapore: Alnylam Pharmaceuticals and Ascletis Pharmaceuticals have formed a strategic collaboration for the development of ALN-VSP, a first-in-class, systemically delivered RNAi therapeutic for the treatment of liver cancers including hepatocellular carcinoma (HCC).
This collaboration is expected to meet the unmet demands in the field in China and provides Ascletis with the exclusive rights to develop and commercialize ALN-VSP in China including Hong Kong, Macau, and Taiwan. Alnylam will retain all rights in the rest of the world, and is eligible to receive milestones and royalties based on product sales.
Dr Laurence Reid, senior VP and chief business officer, Alnylam, said that, "We believe Ascletis has the appropriate expertise in place to advance ALN-VSP through that region's clinical and regulatory system. As an organization, they aim to develop first-in-class medicines for the Chinese market and, given the encouraging clinical data seen to date with ALN-VSP, this represents a unique opportunity for them to make a significant impact."
Dr Jinzi J Wu, president and CEO, Ascletis, said that, "Liver cancers, and specifically HCC, are a major unmet need in China, which has the highest incidence of this aggressive cancer in the world. No effective therapies currently exist for this disease."
The initial focus will be on advancing ALN-VSP into a phase II study for the treatment of HCC. ALN-VSP has completed a phase I study in patients with advanced malignancy with liver involvement and patients that achieved stable disease or better have been enrolled into an extension study. Results of the phase I study in 41 patients were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2011 and demonstrated proof of RNAi mechanism based on liver biopsy samples and disease control (stable disease or better after first two months) in 13/31 (42 percent) patients treated at doses greater than or equal to 0.4 mg/kg.
