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Calando Announces Initial RNAi Product, Goals for 2007

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Calando Pharmaceuticals Inc., a majority-owned subsidiary of Arrowhead Research Corporation has provided more detail on its product and business goals for 2007.

"We have made considerable progress since we commenced operations in mid-2005 - we set very ambitious goals for Calando in 2005 and 2006 to lay the foundation for our product pipeline and future partnerships," said John Petrovich, President and Chief Executive Officer of Calando.

"In 2007, we will build on this foundation by continuing to advance our first experimental RNAi therapeutic toward clinical trials, in hopes of commencing Phase I trials before the end of the year."

According to Calando Chief Scientific Officer, Dr. Jeremy Heidel, Calando's first RNAi therapeutic would direct the silencing of a gene implicated in a wide variety of solid tumors.

"Our success in pre-clinical studies involving different types of cancer cells provides us with optimism about the prospects of treating numerous types of cancer patients with this therapeutic."

Calando's first therapeutic contains a targeting ligand the cell surface receptor for which is over-expressed on a wide variety of different cancers.

The combination of a generalized gene target and a generalized cell surface receptor targeting ligand endow Calando's therapeutic with features that make it potentially applicable for the treatment of a broad spectrum of solid cancers.

In addition to identifying the initial gene target for its first therapeutic, Calando has:

- Filed for patent protection of its siRNA sequences for the gene target, and licensed key siRNA patents from Alnylam Pharmaceuticals.

- Established scale-up and manufacturing relationships for both the siRNA component and Calando's proprietary cyclodextrin-polymer delivery system, and ordered materials for IND-enabling toxicity studies and cGMP materials for its Phase I trial. Manufacturers include Agilent TechnologiesCambrex and SunBio.

- Established safety profile for the complete therapeutic, systemically administered in non-human primates.

Calando is currently planning to file an Investigational New Drug (IND) application with the US Food and Drug Administration, and upon clearance of regulatory requirements and institutional review by the clinical trial site, Calando hopes to begin its first clinical trial at a leading Southern California cancer center before the end of 2007.

"Calando's therapeutic is a targeted RNAi therapeutic designed de novo," said Dr. Mark Davis, Caltech professor and Calando Founding Scientist.

"It combines synthetic delivery components with targeting agents and siRNAs that do not require chemical modification to create the first of its kind nanoparticulate therapeutic for cancer."

"The therapeutic is an 'intelligent' nanoparticle that has shown excellent safety and lack of immunostimulatory effects in rodent and non-human primate studies."

"We are excited to transition targeted siRNA-based therapeutics to the clinic as all in the field realize that effective, targeted delivery is the holy grail."

Calando also hopes to announce an additional development candidate in the second half of 2007, as it continues to expand its pipeline of RNAi therapeutics programs.