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Arrowhead Research Corporation (NASDAQ:ARWR) announced today that its majority owned subsidiary, Calando Pharmaceuticals, a leading siRNA therapeutics company, 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 today at 10:30 a.m. 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 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.
Dr. Anzalone's presentation, followed by a question and answer period, will be broadcast live via the Internet and by teleconference beginning at 10:30 a.m., and a replay will be available for those who are unable to attend the live broadcast. Information on how to access the webcast can be accessed on Arrowhead's website at arrowres.com/meeting2008.html.
About Arrowhead Research Corporation
Arrowhead Research Corporation (www.arrowheadresearch.com) is a publicly-traded nanotechnology company commercializing new technologies in the areas of life sciences, electronics, and energy. Arrowhead is building value for shareholders through the progress of majority owned subsidiaries founded on nanotechnologies originally developed at universities. The company works closely with universities to source early stage deals and to generate rights to intellectual property covering promising new nanotechnologies. Currently, Arrowhead has five subsidiaries commercializing nanotech products and applications, including anti-cancer drugs, RNAi therapeutics, fullerene anti-oxidants, carbon-based electronics and compound semiconductor materials.
About Calando Pharmaceuticals Inc.
Calando Pharmaceuticals Inc. (www.calandopharma.com) is using its proprietary technologies in targeted polymeric delivery systems and siRNA design to design and create new, targeted siRNA therapeutics. Small interfering RNAs (siRNA) induce RNA interference, or RNAi, a naturally occurring mechanism within cells to selectively silence and regulate specific genes. The ability to silence genes through RNAi could provide a new way to treat a wide range of human diseases. The company is pursuing this goal through its internal research and development and also through collaborations and partnerships with pharmaceutical and biotechnology companies.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. One can identify these forward-looking statements by the use of the words "expect," "anticipate," "plan," "may," "will," "estimate" and other similar expressions. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the recent economic slowdown affecting technology companies, the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments and general economic conditions. Our latest Annual Report on Form 10-K, recent and forthcoming Quarterly Reports on Form 10-Q, recent Current Reports on Forms 8-K, our Registration Statements on Form S-3, and other SEC filings discuss some of the important risk factors that may affect our business, results of operations and financial condition. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.
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