Released on: June 10, 2008, 2:18 pm

Press Release Author: GTCbio

Industry: Biotech

Press Release Summary: 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

Press Release Body: MONROVIA, CA - 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.

For more information including a detailed agenda, exhibitor opportunities and
registration information visit http://gtcbio.com/conferenceDetails.aspx?id=128.
ABOUT GTCbio
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.

Web Site: http://www.gtcbio.com

Contact Details: Contact: GTCBIO (626) 256-6405, (626) 256-6460 fax,
Jason.yi@gtcbio.com
434 W. Foothill Blvd
Monrovia, CA 91016