Arrowhead Research Subsidiary, Insert Therapeutics, Receives FDA Approval for IT-101 Phase 1 Clinical Trials for Patented Nanotechnology-Based Therapeutic Set to Begin
PASADENA, California – March 14, 2006 – Arrowhead Research Corporation (NASDAQ: ARWR) announced today that the U.S. Food and Drug Administration has approved the Investigational New Drug (“IND”) application submitted by its majority-owned subsidiary Insert Therapeutics, Inc. Under the IND, Insert will conduct a Phase I study for IT-101, its first anti-cancer therapeutic, at the City of Hope in Duarte, California.
IT-101 is a nanotechnology-based therapeutic that combines Insert’s patented Cyclosert™ technology and the anti-cancer compound camptothecin. Cyclosert is a linear cyclodextrin polymer that was invented at Caltech in the lab of Dr. Mark Davis, a professor in Chemical Engineering and founder of Insert. Insert holds an exclusive license to Cyclosert and has conducted numerous animal studies showing the safety of the Cyclosert delivery platform and the efficacy of IT-101.
“FDA clearance to begin clinical trials is another significant milestone for Insert on the road to becoming a leader in nanotechnology-based therapeutics,” said R. Bruce Stewart, Arrowhead’s Chairman. “This accomplishment reflects Insert’s capability and commitment to commercialize the Cyclosert platform for cancer and other diseases.”
Analogues of camptothecin, such as irinotecan and topotecan, realize nearly $1 billion in worldwide sales annually, despite the numerous unwanted side effects of these medications. In preclinical animal studies conducted by Insert, treatments with IT-101 appear to be substantially more effective, resulting in protracted anti-tumor activities, at significantly lower doses than all other treatments, including those with irinotecan. In some tumor types, IT-101 has caused complete remission of tumors.
The Phase I trial will be an open-label, dose-escalation clinical trial of IT-101 in patients with all types of cancer. The trial is expected to enroll between 24 and 48 patients and has been designed to determine safety and tolerability of IT-101.
For more information about Insert and its technology, please visit Insert’s website at www.insertt.com.
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.
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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 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