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Group Leader of Experimental Therapeutics at Celgene to Present at GTCbio’s 2nd Protein Therapeutics Discovery & Development Conference

Kanji Takada, Group Leader of Experimental Therapeutics at Celgene to Present at GTCbio’s 2nd Protein Therapeutics Discovery & Development Conference on September 8-9, 2008 in San Diego, CA.

Monrovia, ME, June 13, 2008 --( Dr. Kanji Takada, Group Leader of Experimental Therapeutics at Celgene will be speaking at GTCbio’s 2nd Protein Therapeutics Discovery & Development conference on September 8-9, 2008 in San Diego, CA. Dr. Takada will present on novel percutaneous and oral DDS of protein drugs.

With the advance of microfabrication technology, microparticles can be prepared individually. Dr. Takada is been working on new microparticles having non-cubic and asymmetric shapes, ie micropiles (MP) and three-layered microcapsules (TLMC). MP and TLMC were designed as novel percutaneous and oral DDS (gastrointestinal mucoadhesive patch system; GI-MAPS) for protein drugs.

MP is made of water-soluble thread-forming polymer as the base which contains protein. After the administration of MP by inserting into the skin, base dissolves rapidly and releases protein that is absorbed into the systemic circulation. POC experiments with pen-type MP containing insulin, EPO, IFN and growth hormone (GH) showed high bioavailability (BA), 70-99%, in mice, rats and dogs. For insulin, IFN and GH, the absorption rate is almost the same as sc injection preparation. Experimental Therapeutics has developed a machine to produce patch having 100 MPs on itself, 1.0 c? patch, where the length of MP is 500μm and the diameter of the bottom is 300μm. MP patch containing insulin showed physiological availability (PA) of 30% in rats after application to the skin. BA study with MP containing FITC-dextran (FD) having different MW showed a dose-dependence. As MW increased, BA decreased. With FD of which MW is smaller than 40kDa, high BA, around 50%, was obtained. With higher MW FD, BA decreased. However, as the delivery to the skin immune system is available, MP is also applicable to proteins acting to immune system.

GI-MAPS is composed of (1) surface layer, (2) drug carrying layer and (3) basement. The concept of GI-MAPS is (1) to protect drug from the hydrolysis by the digestive enzymes and (2) to obtain high concentration gradient of drug and absorption enhancer between the intestinal mucosal surface by adhering to the target site of the intestine and enterocytes. POC experiments with G-CSF, EPO and IFN showed PA of 23% for G-CSF, BA of 12% and 6% for EPO and IFN. As Experimental Therapeutics has developed a large-scale production machine that works under GMP condition and produces 500-1000μm GI-MAPS, the development of oral protein delivery system will be accelerated. Experimental Therapeutics is also trying to develop the second generation machine by which smaller size TLMC can be produced. With this TLMC, sustained-release sc injection preparation of protein can be produced in the near future.

GTCbio’s 2nd Annual Protein Therapeutics Discovery and Development Conference will explore the therapeutic applications of proteins, with a look at discovery and design of therapeutics, overcoming challenges associated with protein based drugs, and new tools and strategies in process development. Finally, attendees will get an update on novel developments in protein therapeutics. The keynote presentation will be given by Dr. Michael Hanley, Vice President of Discovery Research & CSO of Amylin Pharmaceuticals.

GTCbio organizes conferences specifically for the biomedical and biopharmaceutical industries. Our goal is to facilitate the exchange of biopharmaceutical and biomedical intelligence between industry leaders, academic and government organizations, and the financial community.

GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company founded in 2002.

Contact: GTCbio (626) 256-6405, (626) 256-6460 fax

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Rania Hafez

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