CALANDO PHARMACEUTICALS PHASE II CLINICAL STUDY OPENS TO PATIENT ENROLLMENT
Pasadena, CA - September 11, 2008 - Calando Pharmaceuticals, Inc., a majority owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), announced today that it has initiated a Phase II clinical trial in the United States evaluating the safety and efficacy of its drug candidate, IT-101 in patients with platinum-sensitive ovarian cancer. The study is open for enrollment.
Previous work with IT-101 suggests that twice monthly "maintenance doses" of IT-101 given after the patient’s standard chemotherapy may have minimal side effects, allowing for improved quality of life, and improved progression free survival. This Phase 2 study is designed to determine if IT-101 treatment initiated after a standard 2nd line course of platinum chemotherapy in patients who have stable disease, a partial response, or a complete response can delay disease progression.
The study is expected to enroll 150 patients in the United States and is co-led by Jonathan S. Berek MD, MMS, Professor and Chair, Department of Obstetrics and Gynecology, Stanford University School of Medicine and the Stanford Cancer Center and Franco Muggia, MD, Anne Murnick Cogan and David H. Cogan Professor of Oncology, Director of the Division of Medical Oncology at NYU Medical Center, and Associate Director for Clinical Research. A team of experts from Dana Farber, Sloan Kettering, Columbia University, and M.D. Anderson comprise the Data Safety Monitoring Committee.
IT-101, a conjugate of camptothecin and Insert's proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and pharmacokinetic characteristics.
About Arrowhead Research Corporation
About Calando Pharmaceuticals, Inc.
Calando Pharmaceuticals Inc. (www.calandopharma.com), a majority-owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), is a biopharmaceuticals company using proprietary technologies developed at Caltech to create targeted siRNA-based therapeutics and small molecule nanoparticle drug conjugates. Calando uses its innovative Cyclosert™ and RONDEL™ nanoparticle systems to solve the long-standing obstacle of effective delivery and targeting for oligonucleotide and small molecule therapeutics.
Calando’s Cyclosert™ technology uses cyclodextrins as building blocks to create an entirely new class of biocompatible materials - linear cyclodextrin-containing polymers that are non-toxic and non-immunogenic at therapeutic doses. The Company leverages Cyclosert™ to design, develop and commercialize drug-delivery-enhanced small-molecule therapeutics. IT-101 is Calando’s lead small molecule Cyclosert conjugate, which recently completed a phase I study in solid tumors at City of Hope Comprehensive Cancer Center.
Calando’s RONDEL™ technology involves the use of cyclodextrin-containing polymers that form the foundation for its two-part siRNA delivery system. The first component is a linear, cyclodextrin-containing polycation that, when mixed with small interfering RNA (siRNA), binds to the anionic “backbone” of the siRNA. The polymer and siRNA self-assemble into nanoparticles smaller than 100 nm in diameter that fully protect the siRNA from nuclease degradation in serum. The siRNA delivery system has been designed to allow for intravenous injection. Upon delivery to the target cell, the targeting ligand binds to membrane receptors on the cell surface and the RNA-containing nanoparticle is taken into the cell by endocytosis. There, chemistry built into the polymer functions to unpackage the siRNA from the delivery vehicle. Based upon this breakthrough in siRNA delivery enabled by the RONDEL™ system, the promise of using siRNA in new systemic therapies may finally be realized.
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 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. Arrowhead Research Corporation’s Annual Report on Form 10-K and 10-K/A, recent and forthcoming Quarterly Reports on Form 10-Q and 10-Q/A, recent Current Reports on Forms 8-K and 8-K/A, 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.