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Dr. Jay Cohen

The Endocrine Clinic in Memphis has been chosen as the second study site in the United States to participate in an exciting new clinical trial of MGA031, an anti-CD3 monoclonal antibody developed to treat type 1 diabetes mellitus.

The CD3 mAb trial is an international trial which will begin in November and involve approximately 35 sites across the United States, Europe, Israel and South America.

"We're fortunate that we were approached to participate in this trial," said Dr. Jay Cohen, the lead investigator for the trial and medical director at The Endocrine Clinic.

Since it is a double-blind trial, neither the physician nor the patient will know if the patient will be receiving a placebo or the CD3 mAb. Patients will receive daily infusions for 30 minutes for 14 days onsite at The Endocrine Clinic. The trial will last one year from the time a patient enrolls. "We'll be enrolling patients who have been newly diagnosed with type 1 diabetes. Newly diagnosed means they will have been diagnosed within six weeks of enrollment," said Cohen.

Hopefully, 25 patients from the region who are between the ages of eight and 30 will be recruited for the trial, said Cohen. Interested patients may come from as close as Memphis or as far away as St. Louis, Little Rock, Nashville and Birmingham.

Since participants will be need to be newly diagnosed, Cohen said it is essential for the Memphis community to know about the trial and how to refer possible candidates.

"We want to develop a Memphis consortium so we can pull together resources from the community including JDRF, local emergency room physicians, healthcare facilities and providers, nurse practitioners, fellows and anyone else," he said.

Because of the promising nature of the treatment, CD3 mAb received orphan drug designation from the FDA on October 10, 2006. CD3 mAb is manufactured by MacroGenics, a biotechnology company located in Rockville, Md., that focuses on the development of immunotherapeutics for autoimmune disorders, cancer and infectious diseases.

"This is our lead program for the company. At this point, the FDA is giving us the opportunity to see if the therapy meets all the required efficacy and safety requirements," said Nelson Campbell, MacroGenics chief financial officer.

Orphan drug status is given to products for diseases or conditions upon request of a sponsor and approval from the FDA. In previous studies, CD3 mAb has shown the ability to interfere with the autoimmune mechanism which leads to type 1 diabetes. "Orphan status means that it has been given a special priority," explained Cohen.

In type 1 diabetes, the body attacks the pancreatic beta cells, and as Cohen explained, young patients are actually missing the mechanism or "key" that allows the body to process insulin and maintain normal glucose levels. CD3 mAb binds to an epitope of the CD3-epsilon chain expressed on mature T cells and interferes with the autoimmune mechanisms that lead to the destruction of cells.

Cohen reported that physicians are cautiously optimistic about the possible breakthrough. "Dr. Wiley Robinson said to me recently, 'Jay, this could be the biggest breakthrough I've seen since becoming a doctor.' We hope, but we don't know," he said. "That's why we are having the trial."

Nelson reported that MacroGenics took on the responsibility of further developing the technology that was pioneered by Jeffrey Bluestone, PhD, of the University of California. "The CD3 mAb has been studied for years before now," said Nelson.

The American Diabetes Association reports that one in every 400 to 500 children will develop juvenile diabetes, usually under the age of 30, with many diagnosed before the age of 18. "Type 1 causes all kinds of chronic long-term damage, including increased risk of stroke, heart attacks, blindness and other complications. If we can dramatically decrease the need for insulin, we will not only improve costs, but we will improve the quality of our patients' lives," says Cohen.

The Endocrine Clinic, which is the largest clinic of its kind in this part of the country, is actively and consistently involved in research and trials of diabetes and other significant endocrine diseases. "The CD3 mAb trial is just one of 14 trials that we are conducting right now," said Cohen.

The clinic has six physicians and three nurse practitioners and treats 6,000 diabetics.

Recruiting for the clinical trial is the current goal for Cohen and his staff as the study begins this month. "The key to this is if any healthcare provider has a brand new case, we urge the physician, not the patient, to contact our 24-hour number and we'd be happy to talk with them further about the trial."

Further information about the trial can be obtained 24-hours a day at (901) 763-3636.






November 2006

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