Hollis-Eden reports positive interim data from Phase I/II diabetes trial

Sep 26, 2008 (Datamonitor via COMTEX) -- HEPH | Quote | Chart | News | PowerRating -- Hollis-Eden Pharmaceuticals, a development-stage pharmaceutical company, has reported additional positive interim data from its on-going Phase I/II clinical trial with its investigational oral drug candidate Triolex in obese insulin resistant subjects.

The additional data showed that Triolex is safe and well tolerated to date, and that it significantly improved insulin sensitivity and lowered fasting blood glucose and insulin levels in obese insulin resistant subjects treated orally with 5mg or 10mg of the compound administered twice daily for 28 days, as compared to placebo-treated subjects.

The data showed that insulin resistant subjects displayed a significantly exacerbated inflammatory response characterized by higher levels of the pro-inflammatory cytokines MCP-1, TNF-alpha, IL-6 and IL-1beta produced in lipopolysaccharide stimulated peripheral blood mononuclear cells from these patients.

In contrast to more insulin sensitive subjects (M>5), treatment of these insulin resistant subjects (M<5) with Triolex was associated with a positive trend towards lowering these inflammatory cytokines, which in turn was accompanied by signs of glucose lowering in the same subjects.

The data also showed that retinol-binding protein 4 (RBP4), a protein secreted by fat cells that is associated with insulin resistance, was markedly decreased in the insulin resistant subjects (M<5) treated with Triolex compared to placebo-treated subjects. In addition, C-reactive protein was significantly decreased in the insulin resistant subjects (M<5) compared to placebo-treated subjects (p = 0.018), the company said.

Richard Hollis, chairman and CEO of Hollis-Eden, said: "If Triolex is successfully developed, we believe that the ability to regulate both glucose homeostasis and inflammation may result in a better and safer insulin sensitizer and make a significant advancement in the treatment of type 2 diabetes as well as potentially be beneficial in mitigating the serious consequences associated with uncontrolled inflammation in cardiovascular disease."

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