Friday, January 23, 2009

Alnylam to enroll liver cancer patients for Phase 1 study

By Mass High Tech staff

Alnylam Pharmaceuticals Inc., an RNAi therapeutics development firm in Cambridge, has been given FDA clearance to begin enrolling patients for its Phase 1 study of a liver cancer treatment. The clearance follows Alnylam’s investigational new drug application submitted to the FDA for its ALN-VSP treatment.

ALN-VSP uses two small interfering RNAs (siRNAs) in a lipid nanoparticle, developed by Tekmira Pharmaceuticals Corp., to silence tumor growth genes.

The Phase 1 study will measure the safety and tolerability of intravenous ALN-VSP in patients diagnosed with advanced solid tumors associated with liver cancer.

Alnylam (Nasdaq: ALNY) officials said they expect to begin the clinical study in the first half of 2009, with the company-wide goal of implementing three clinical trials this year.

Alnylam was named a 2009 Technology Pioneer by the World Economic Forum, an international body that aims to tape business and cultural leaders to improve worldwide conditions, for its work in RNA interference (RNAi), a promising area that has the potential to create a broad new class of human therapeutics.