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www.fdanews.com/articles/89666-hollis-eden-presents-promising-data-on-arthritis-compound

HOLLIS-EDEN PRESENTS PROMISING DATA ON ARTHRITIS COMPOUND

February 5, 2007

Hollis-Eden Pharmaceuticals has presented data showing that HE3286, an orally bioavailable small-molecule compound, produced a statistically significant reduction in disease in a rodent model of established arthritis.

The data adds to positive results from a previous preclinical study in which treatments of HE3286 initiated at disease onset significantly reduced disease. In that study, treated animals had nearly double the frequency of regulatory T cells in their spleens at the end of the 50-day study, suggesting that treatment with androstene hormones such as HE3286 can modulate the function and frequency of regulatory T cells in animals. Regulatory T cells have been shown to play major roles in the control of all immune responses, according to the company. Specifically, deficiencies in regulatory T cell activity are thought to play a crucial role in the development of many autoimmune diseases, including arthritis and multiple sclerosis.

The new data show that when treatments begin late in the disease course, HE3286 can still produce dramatic reductions in disease. Mice were immunized to induce disease, and one week after disease onset were treated orally with HE3286 or placebo. While the severity of arthritis worsened steadily in the placebo group, it nearly resolved or remained at a minimum in the HE3286 group.

"The ability to treat established disease in this indication is highly clinically relevant," Richard Hollis, chairman and CEO of Hollis-Eden, said. "These findings further demonstrate the potential of our technology platform from which we intend to launch multiple, potentially first-in-class compounds with therapeutic activity in a broad range of indications including infectious diseases, autoimmune and metabolic disorders, cancer and other diseases associated with aging."