NIH to Sponsor Preclinical Study of DiaKine Diabetes Drug.

DT 22669's Potential to Prevent and Reverse Diabetes in Animals Investigated

CHARLOTTESVILLE, Va. -- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a section of the National Institutes of Health (NIH), will sponsor preclinical testing of a new oral drug being developed by DiaKine Therapeutics that may prevent or reverse diabetes.

In awarding the sponsorship, the NIH reviewers saw "high scientific merit and novelty" in the proposal. The study, part of the type 1 diabetes preclinical testing program (T1D-PTP), is a predecessor to human clinical trials and is necessary to establish "proof of principle" of the new compound.

"Receiving this sponsorship from the NIDDK is recognition of the potential for this new oral drug to prevent or reverse diabetes," said Dr. Jerry Nadler, DiaKine's Chief Scientific Officer. "In this study DT 22669 an oral drug will be tested in the best established preclinical models of type 1 diabetes and if successful, to make ready for human clinical trials."

In preliminary research conducted by Dr. Nadler and Dr. Zandong Yang, DT 22669 has demonstrated preclinical efficacy in protecting human beta-cells from cytokine damage and in reducing the development of type 1 diabetes in a rodent model.

"We believe DiaKine's oral drug alone or in combination with other beta cell growth factors could reverse or prevent diabetes would change the lives of millions of people," said Keith Ignotz, President, and CEO of DiaKine.

Drugs being developed by DiaKine modulate inflammatory cytokines, part of the body's immune system, which sometimes mistakenly attack normal organs and tissue and cause diseases such as diabetes and related complications such as kidney and eye disease. Research by Dr. Nadler and his collaborators published in 2006 showed that controlling certain cytokines can arrest the progression of, or reverse, type 1 diabetes in an animal model.

DiaKine therapies may improve the function of insulin-producing cells and preserve any that remain in the pancreas after initial diagnoses thereby halting the progression of newly diagnosed type 1 diabetes. Those patients with established diabetes may be relieved from the lifelong burden that results from this disease by providing them with new insulin producing cells through either transplantation or regeneration and modulating the immune system with these new medications. Protecting new insulin-producing cells from a new immunological attack may reverse diabetes and prevent the resulting complications associated with this dreadful disease.

About DiaKine

DiaKine Therapeutics, Inc. is a development-stage company commercializing novel immune modulators initially targeting the treatment of autoimmune and inflammatory diseases such as diabetes and related complications. The Company designed its first product, IsletLife-LSF Media 1, to improve the viability and insulin producing capabilities of harvested islet cells prior to transplant. IsletLife-LSF Media can potentially improve the success rate of the procedure. Additional therapeutics under development by DiaKine include: adjunct therapy to islet cell transplants, halting the progression of type 1 diabetes in newly diagnosed adults, treatment and prevention of Latent Autoimmune Diabetes of Adults (LADA), treatment and prevention of insulin requiring type 2 diabetic, treatment and prevention of diabetes complications. For more information, visit www.diakine.com.