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Arrowhead Research (Pasadena, California) reported that European Patent No. 1093469, titled "Linear Cyclodextrin Copolymers," has been issued to the California Institute of Technology (also Pasadena). The patent is exclusively licensed to Arrowhead's majority owned subsidiary, Insert Therapeutics (also Pasadena), a company commercializing delivery-enhanced therapeutics using a patented class of polymeric systems.

"Having strong patent protection is crucial to high tech companies, particularly those in the nanotech space," said Bruce Stewart, Arrowhead's chairman. "Arrowhead will continue to aggressively build and protect our intellectual property rights."

The patent covers all of the claims in three previously issued U.S. patents covering the composition, method of preparation and methods of use of a new class of polymers for delivery of therapeutic compounds. Insert Therapeutics' Cyclosert technology platform is a part of the family of polymers covered by these patents and represents a significant advance in the use of cyclodextrins for delivery of therapeutic compounds, the company said.

Insert is currently using Cyclosert technology in its lead drug candidate, IT-101, an experimental drug being studied for the treatment of cancer in Phase I clinical trials at City of Hope Cancer Center (Duarte, California). Insert expects to begin multiple Phase II trials later this year. IT-101 is a conjugate of one of the Cyclosert polymers and the anti-cancer, small-molecule drug camptothecin.

Insert also has licensed a portion of the polymer family to its affiliate, Calando Pharmaceuticals (also Pasadena), which is using polymers to deliver siRNA duplexes in the area of RNA interference, a gene-silencing technology that may lead to an entire new class of therapeutics, the company said. Calando is preparing to file with the FDA to begin clinical trials later this year.

The claims cover polymers containing repeating units of cyclodextrin molecules and various co-monomers, linked together in a linear chain. In contrast to other approaches that graft molecules onto a polymer, the claimed polymers incorporate the cyclodextrin molecules into the polymer "backbone." This feature has aided in scale-up and resulted in more consistent commercial manufacture. Insert's linear cyclodextrin-containing polymers can form complexes with compounds ranging in size from small-molecule drugs to nucleic acids for improved therapeutic effects.

Other issued and allowed patents cover various means of adding modifier components to the polymer that aid the stability of the resulting polymer-drug nanoparticles in vivo and allow for the attachment of various targeting ligands. Arrowhead Research is a nanotechnology company commercializing new technologies in the areas of life sciences, electronics, and energy.

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