Hollis-Eden Pharmaceuticals Inc. (HEPH) on Monday reported that the data from an on-going phase I/II clinical trial showed that Triolex is safe and well tolerated, and improves insulin sensitivity and lowers fasting glucose levels in obese insulin resistant subjects.
The phase I/II clinical trial is a 28-day double-blind placebo controlled clinical study, which was designed to study the safety, tolerability, pharmacokinetics and potential activity of Triolex at three dose levels when administered orally to obese insulin resistant subjects.
No serious adverse events or systemic toxicity were found from Triolex in all treated subjects, and all adverse events reported were mild and required no treatment, the company noted.
Hollis-Eden said it is now initiating a follow-on Phase II clinical trial to demonstrate efficacy in long-term glycemic control in type 2 diabetic patients by assessment of HbA1-c levels, an approvable end-point for diabetes.
HEPH is currently trading at $2.21, up 27 cents or 13.92%.
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