Akesis Pharmaceuticals Expands Preclinical Safety Program for Lead Product

25-Sep-2008 - USA

Akesis Pharmaceuticals, Inc. announced the initiation of the next phase of the preclinical safety program for AKP-020. While an analysis of the one-month preclinical safety studies is ongoing, the company has initiated a three-month preclinical safety program in order to support further clinical evaluation of its product. Combined with the thorough analysis of the recent Phase IIa study of AKP-020 in diabetic subjects, the company anticipates a delay in the next phase of clinical studies where the next human study would not begin until the second half of 2009, following appropriate regulatory feedback.

“While we remain optimistic about AKP-020 as a potential therapy for diabetes, we believe that an expansion of our preclinical programs is necessary to further our understanding of the benefit/risk profile of AKP-020 prior to the initiation of additional clinical studies” said Jay Lichter, Chairman and Chief Executive Officer of Akesis. “Contingent on the results of this expanded program, we anticipate being in a position to better define our future development strategy and timeline for AKP-020.”

AKP-020 is the product designation for a novel vanadium compound otherwise known as bis(ethylmaltolato)oxovanadium (IV), or BEOV. The compound was invented and developed by University of British Columbia researchers Chris Orvig, professor of chemistry and pharmaceutical sciences, and John McNeill, Ph.D., professor and dean emeritus, pharmaceutical sciences, and is licensed exclusively to Akesis. Professors Orvig and McNeill, who are experts in the study of metal chemistry and pharmaceutical sciences, helped to advance the BEOV program through Phase I clinical trials. They also are members of the Akesis Scientific Advisory Board.

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