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news.Alnylam Pharmaceuticals, an RNAi therapeutics company, has submitted an investigational new drug application to the FDA for ALN-VSP, an RNAi therapeutic for the treatment of liver cancers, including hepatocellular carcinoma and other solid tumors with liver involvement.
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ALN-VSP contains two small interfering RNAs (siRNAs), the molecules that mediate RNAi, formulated in a lipid nanoparticle developed by Tekmira Pharmaceuticals.
The proposed Phase I study is a multi-center, open label, dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP in patients with advanced solid tumors with liver involvement. Additional study design details are expected to be provided upon initiation of the Phase I trial.
Akshay Vaishnaw, senior vice president of clinical research at Alnylam, said: ALN-VSP represents Alnylam’s first investigational new drug (IND) for a systemically delivered RNAi therapeutic, which is a testament to the very strong progress we’ve made in achieving systemic delivery of siRNAs, including our efforts with Tekmira.
We’re also pleased, with this IND filing, to have met one of our key pipeline goals for 2008. Following FDA review of our submission, we expect to initiate patient dosing in the first half of 2009, which positions us solidly on track to meet our goal of having three programs in clinical trials next year.