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news.Tekmira Pharmaceuticals, a biopharmaceutical company, has filed an investigational new drug application seeking approval from the FDA to begin a Phase I human clinical trial to evaluate the company's lead product candidate ApoB SNALP as a treatment for elevated low-density lipoprotein cholesterol.
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The FDA has 30 days to review Tekmira’s investigational new drug (IND) application and to request any additional information before allowing the clinical trial to proceed. Tekmira will provide guidance at the end of the FDA review period about the initiation and the details of the Phase I clinical trial, which is expected to begin before mid-year 2009.
Tekmira’s therapeutic approach is to address the underlying cause by targeting ApoB, a protein synthesized in the liver that is essential to the assembly and secretion of very low density lipoprotein, a precursor to low density lipoprotein, both of which are required for the transport and metabolism of cholesterol.
Mark Murray, president and CEO of Tekmira, said: “The filing of the ApoB SNALP IND marks an important transition for Tekmira as our technology moves towards human clinical development and supports Tekmira’s leadership position in the advancement of RNAi therapeutics.”