Sirna completed its preclinical evaluation of the efficacy of Sirna-AV34 and has begun manufacturing for its phase I clinical studies. Sirna will conduct toxicology studies in the first quarter of 2006 followed by the filing of an investigational new drug application with the FDA by the fourth quarter of 2006.
Sirna-AV34 is a systemically delivered, nanoparticle-based therapeutic targeting the hepatitis C virus. The compound consists of multiple individual, chemically modified, short interfering RNA (siRNA) sequences which target highly conserved sequences in the hepatitis C viral genome.
“The selection of Sirna-AV34 as our clinical candidate reflects two major accomplishments of our research team,” said Sirna senior vice president and CSO, Dr Barry Polisky. “The first is the design, chemical modification and synthesis of a stable and potent siRNA compound which is effective broadly against the hepatitis C virus. The second is the development of a proprietary nanoparticle delivery technology capable of efficient and specific delivery of the siRNA compound to hepatocytes.”