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FDA Accepts Innovative Drug Application – ImmunoMod Begins Diabetes Therapeutic Trials

July 25, 2007

ImmunoMod, LLC, a Charleston, SC-based biotechnology company, has received an FDA Orphan Drug Grant award for a Type 1 diabetes therapeutic and is beginning its first human patient trials at the Children’s Hospital of Philadelphia.

ImmunoMod, a spin-off from the Medical University of South Carolina (MUSC), that is developing novel therapeutics to alleviate suffering caused by diabetes, was founded in 2006 by two nationally renowned MUSC pediatric physicians–Dr. Lyndon Key, department chair, and Dr. Inderjit Singh, PhD, scientific director of the Children’s Research Institute–along with Charleston businessman Bob Faith, chairman and CEO of Greystar Real Estate Partners and South Carolina’s former Secretary of Commerce.

It was Faith’s daughter’s onset of Type 1 diabetes, or juvenile diabetes, which led the three to forge a partnership to license intellectual property from MUSC related to pharmaceuticals being developed by Key and Singh to treat diabetes and other related auto-immune disorders. While ImmunoMod is developing treatments for both types of diabetes, its preliminary focus is preventing the onset of Type 1 by protecting beta cell function in early-stage diabetic youth.

“Dr. Singh and I have long been committed to developing a sustainable and safe therapeutic for the prevention, treatment and cure of early-stage Type 1 diabetes,” said Dr. Key. “We are grateful for the FDA’s grant and hopeful that this therapeutic will provide a better option for the nearly 20,000 Americans, primarily children, who are diagnosed annually with juvenile diabetes.”

Juvenile diabetes is a chronic autoimmune condition in which a person’s pancreatic beta cells, which create insulin, are destroyed, thus creating the need for external insulin. The body needs insulin to convert sugar, starches and other food into energy required for daily life.

Type 1 diabetes onset occurs when beta cells can no longer keep glucose levels stable. Within two to three years, beta cells can completely lose the ability to function.

While some treatments have decelerated beta cell destruction, their effects have been temporary, caused toxic effects and required continuous treatment. ImmunoMod’s therapeutic appears to effectively and safely protect beta cells for prolonged periods of time. The goal is to retard or reverse the destruction of these cells during the honeymoon phase, when cells first begin to lose function, which typically lasts about six months.

To learn more, visit www.immunomod.com.




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