Arrowhead Research Corporation has announced that its majority owned subsidiary, Calando Pharmaceuticals submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration to initiate a Phase I clinical trial using their lead anti-cancer compound, CALAA-01.
Dr. Anzalone will discuss the IND filing, Calando's clinical plans, and Arrowhead's other 2008 objectives in a webcast presentation following the Annual Meeting of Shareholders at 10:30 AM PT.
"Calando's technology addresses a primary obstacle to the use of siRNA therapeutics: an effective delivery mechanism," said Dr. Christopher Anzalone, Arrowhead's Chief Executive Officer. "RNAi could provide a new way to treat a wide range of human diseases and, and we believe this is a major step forward for siRNA therapeutics.
To our knowledge, this stands to be the first use of siRNA for treatment of cancer in humans. This submission represents an important milestone for Calando and we look forward to starting our work in the clinic."
The drug candidate is a targeted nanoparticle, comprised of a proprietary, non-chemically-modified siRNA against the M2 subunit of ribonucleotide reductase, a clinically-validated cancer target, and Calando's proprietary siRNA polymer delivery system. The system can be used to systemically deliver any siRNA.
The Phase I study is an open-label, dose-escalation clinical trial in patients with non-resectable or metastatic solid tumors. The primary objectives of the clinical protocol submitted with the IND are to evaluate the safety and tolerability of CALAA-01 in humans.
Additional objectives include characterization of pharmacokinetics, evaluation of tumor response, and recommendation of a CALAA-01 dose for future clinical studies. The trial will be conducted at the UCLA Jonsson Cancer Center (UCLA) in Los Angeles, California, and the South Texas Accelerated Research Therapeutics (START) clinic in San Antonio, Texas.