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SC Biotech Firm Begins FDA-Approved Trials on Diabetes Therapeutic

Contact: Clare Morris, 803.413.6808

MUSC Spin-off ImmunoMod Receives FDA Award

Charleston, SC ImmunoMod, LLC, a spin-off company from the Medical University of South Carolina, announced it has received an FDA Orphan Drug Grant award for its Type 1 diabetes therapeutic and is beginning its first human patient trial this summer at the Children's Hospital of Philadelphia.

ImmunoMod, a biotechnology company that is developing novel therapeutics to alleviate suffering caused by diabetes and related auto-immune disorders, was founded in March 2006 by four well-known Charleston residentsDr. Lyndon Key, chair of the Department of Pediatrics at MUSC and physician at MUSC's Children's Hospital; Dr. Inderjit Singh, PhD, professor of pediatrics and scientific director of the Children's Research Institute at MUSC; and Faith Family Holdings, the family partnership of Bob and Elizabeth Faith. Bob is the chairman and CEO of Greystar Real Estate Partners and the state's former Secretary of Commerce. Elizabeth is the founder of ESD, a successful home furnishing and design business with two Charleston locations.

In fact, it was Faith's own daughter's onset of Type 1 diabetes, or juvenile diabetes, which led the group to forge a business partnership to license intellectual property from MUSC related to pharmaceuticals being developed by Key and Singh at MUSC to treat diabetes and other related auto-immune disorders. While the company is developing treatments for both Types 1 and 2 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 support and hopeful that this therapeutic will provide a better treatment option for the nearly 20,000 Americans, primarily children, who are diagnosed each year with Type 1 diabetes."

ImmunoMod has developed a portfolio of pre-clinical and clinical candidates and is scheduled to begin Phase 2 trials with 60 juvenile patients this summer. Since the treatment was originally developed at MUSC, the first clinical trials are being conducted at the Children's Hospital in Philadelphia by Dr. Steve Willi. (Protocol dictates that the trials be held in a different location from where the treatment was developed).

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 insulin from an external source. Insulin is a hormone that the body needs to convert sugar, starches and other food into energy required for daily life. According to the American Diabetes Association, the cause of diabetes is not fully known.

Managing diabetes is challenging, as patients must daily maintain near normal glycemic control by frequent glucose monitoring, multiple daily insulin injections or use of an insulin pump and by adjusting insulin doses for variation in diet and exercise. 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 proven to decelerate beta cell destruction, their effects have been temporary, have caused toxic effects and have 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 the cells first begin to lose function, which typically lasts about six months.

"We are committed to finding a treatment and cure for juvenile diabetes,"

Faith added. "MUSC has long been recognized for its prominence as a world-class medical research facility, and our company is thrilled to be bringing this scientific breakthrough to realization with these FDA-approved human trials. We are equally excited by the prospect of developing a commercially viable treatment that can benefit so many juvenile diabetes patients."

To learn more about ImmunoMod, visit

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“Clare proved to be a valued contributor to SCBio assisting in developing a political and public affairs strategy. Her creative approach and insight played an important role in advancing the corporate mission in both South Carolina and Washington.”

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