Arrowhead Research Corporation (NASDAQ:ARWR) announced today that Calando, its majority owned subsidiary, together with City of Hope (COH) and the UCLA's Jonsson Cancer Center (UCLA) are planning a broad-based Phase I clinical trial to begin later this year for Calando's lead drug candidate, CALAA-01.
"We expect that Calando will be first to human trials with a targeted, formulated siRNA therapeutic designed for the treatment of cancer," said R. Bruce Stewart, Arrowhead's Chairman. "We are honored to be working with distinguished scientists at these two world class institutions."
Calando is performing toxicity studies in rats and monkeys in preparation for the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) and is actively engaged in the scale-up of manufacturing to produce cGMP-grade clinical materials for the Phase I trial. Upon FDA approval, Calando, COH and UCLA plan to conduct an open-label, dose-escalation Phase I clinical trial in patients with unresectable or metastatic solid tumors. The study will be led by Yun Yen, MD, Ph.D., at COH and Antoni Ribas, MD, at UCLA. Based upon the evaluation of the results from this study, Calando plans to conduct separate, disease-specific Phase II trials.
CALAA-01 uses Calando's nano-engineered delivery technology to protect the siRNA from degradation and attack by the immune system as it travels through the body to the cancer cells. The nanotech formulation also contains human transferrin protein (Tf) which promotes targeting to a broad spectrum of cancer cell types. Once the therapeutic binds to the Tf receptor, it is taken up by the cell and its siRNA payload is released. Calando's proprietary siRNA targets the M2 subunit of ribonucleotide reductase, a well-established cancer target.
Arrowhead Research Corporation () is a leading nanotechnology company commercializing new technologies in the areas of life sciences, electronics, and energy. 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 four subsidiaries commercializing nanotech products and applications, including anti-cancer drugs, RNAi therapeutics, 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. 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.