Arrowhead Research Subsidiary, Insert Therapeutics, Treats First Patient with Nano-Engineered Anti-Cancer Therapeutic
PASADENA, California – (BUSINESS WIRE) – July 19, 2006 – Arrowhead Research Corporation (Nasdaq:ARWR), announced today that its majority-owned subsidiary, Insert Therapeutics, a company commercializing delivery-enhanced therapeutics using a patented class of polymeric systems, has treated its first patient in a Phase I study of IT-101, Insert's lead anti-cancer compound.
"The initiation of the clinical development phase for IT-101 is an important milestone for Insert Therapeutics. It demonstrates our commitment to bringing innovative therapies to the clinic that address significant, unmet patient needs," said Dr. Thomas Schluep, Chief Scientific Officer at Insert Therapeutics.
The study is an open-label, dose-escalation Phase I study in patients with inoperable or metastatic solid tumors and has been designed to evaluate the safety, tolerability and pharmacokinetics of IT-101. Insert expects that between 24 and 48 patients will be enrolled in the study during its course. The study is currently being conducted at The City of Hope Cancer Center (COH) in Duarte, CA, where Yun Yen, MD., Ph.D. will lead the study.
"We congratulate the team at Insert on this latest success," said R. Bruce Stewart, Arrowhead's Chairman. "While the Phase I study is underway, Insert will continue preparations for IT-101's further clinical trials and the development of its next therapeutic candidates."
Animal studies using IT-101 showed excellent anti-cancer activity, including complete remission of certain kinds of lung cancer, among others. For more information about Insert and IT-101, please visit Insert's website at www.insertt.com.
About IT-101
IT-101 is a combination of its patented polymer technology, Cyclosert(TM), and the anti-cancer compound camptothecin. Insert's proprietary Cyclosert delivery system is based on small cyclic repeating molecules of glucose called cyclodextrins. Using modified cyclodextrins as building blocks, Insert has developed an entirely new proprietary class of materials called linear cyclodextrin-containing polymers. To the company's knowledge, Cyclosert is the first nanoparticulate drug delivery platform to be designed de novo and synthesized specifically to overcome limitations in existing delivery technologies used for the systemic delivery of therapeutics. The polymers were invented at Caltech in the lab of Dr. Mark Davis, a professor in Chemical Engineering and founder of Insert, and licensed exclusively to Insert.
Cyclosert polymers have been synthesized over a broad range of molecular weights providing tunable properties for systemic drug delivery that improve localization of active drug at the target tissue. This feature of the Cyclosert technology provides great flexibility for overcoming multiple hurdles encountered in formulation and delivery.
Discovered in the 1960s, camptothecin is a naturally occurring, water-insoluble alkaloid that has established potent activity against a broad spectrum of cancer types. Although analogues of camptothecin (e.g., irinotecan and topotecan) continue to realize nearly $1 billion in worldwide sales annually, camptothecin itself has not been commercialized due to its poor solubility and unfavorable pharmacokinetics. In numerous animal studies conducted by Insert, treatment with IT-101 result in protracted anti-tumor activities that are substantially more effective than irinotecan or camptothecin administered alone.
About Insert Therapeutics, Inc.
Insert Therapeutics, Inc. (www.insertt.com), a majority-owned subsidiary of Arrowhead Research Corporation (NASDAQ:ARWR), is using its proprietary, nano-engineered, polymeric delivery system, Cyclosert™, to design, develop and commercialize drug-delivery-enhanced small-molecule therapeutics and nucleic acids. Cyclosert 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. Insert’s affiliate company, Calando Pharmaceuticals, is using a related system for the systemic delivery of siRNA. The companies are pursuing this goal through internal research and development, and also through collaborations and partnerships with pharmaceutical and biotechnology companies.
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.
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 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 Statement 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.
Contacts
Virginia Dadey; Vice President, Investor Relations
Telephone: 212.541.3707
Email: vdadey@arrowres.com
John G. Petrovich
Telephone: 626.683.7200
Email: jpetrovich@insertt.com