CALANDO PHARMACEUTICALS COLLABORATES WITH CITY OF HOPE TO INITIATE INVESTIGATOR SPONSORED CLINICAL TRIAL USING IT-101 IN LYMPHOMA PATIENTS
PASADENA, Calif.- June 12, 2008- Calando Pharmaceuticals, a majority-owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), announced today that it has entered into a collaboration with City of Hope in Duarte, CA to initiate an investigator sponsored clinical trial using Calando's nanoparticle drug candidate, IT-101 in patients with various forms of lymphoma.
The trial will be an open-label, phase II study of IT-101 intended to demonstrate safety and efficacy in patients with relapsed or refractory lymphoma, and will be preceded by a brief dose finding run-in phase. Patients with relapsed or refractory lymphoma, including B cell, T cell, and Hodgkin Lymphoma who satisfy eligibility requirements will be considered for admission to the trial.
"This is a very important and exciting trial to determine the efficacy and tolerability of a rationally designed and novel nanotechnology based drug delivery system of a cancer chemotherapeutic drug, with impressive preclinical activity in lymphoma" said lead investigator, Stephen Forman M.D., Chair, Division of Hematology & Hematopoietic Cell Transplantation at City of Hope.
"We are very pleased to be working with Dr. Forman and City of Hope on this study," said James Hamilton M.D., CEO of Calando Pharmaceuticals. "This represents an excellent opportunity to leverage the IT-101 franchise into additional oncology indications, while minimizing clinical development costs."
IT-101, a drug conjugate of camptothecin and Calando's proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and unique pharmacokinetic characteristics. Calando has recently completed enrollment of an ongoing phase I study of IT-101 at City of Hope Cancer Center for patients with non-resectable solid tumors and has filed with the FDA to initiate a multi-site phase II clinical trial of IT-101 in patients with ovarian cancer.
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 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), 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(TM) and RONDEL(TM) nanoparticle systems to solve the long-standing obstacle of effective delivery and targeting for oligonucleotide and small molecule therapeutics.
Calando's Cyclosert(TM) 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(TM) to design, develop and commercialize drug-delivery-enhanced small-molecule therapeutics. IT-101 is Calando's lead small molecule Cyclosert conjugate, which recently completed enrollment in a phase I study in solid tumors at City of Hope.
Calando's RONDEL(TM) 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(TM) system, the promise of using siRNA in new systemic therapies may finally be realized.
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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.