Epimmune receives FDA clearance to initiate phase I/II therapeutic vaccine trial.(Brief Article)

2002 JUL 17 - (NewsRx.com & NewsRx.net) -- Epimmune, Inc., (EPMN), a biotechnology company focused on the development of pharmaceutical products using multiple, specific epitopes to activate the body's immune system, announced that it has received clearance from the U.S. Food and Drug Administration to start a phase I/II clinical trial of its EP HIV-1090 therapeutic, multiepitope vaccine in HIV-1-infected patients.

The first patients are expected to begin treatment in approximately 4-6 weeks at the University of Colorado Health Sciences Center, where the clinical trials will be conducted under the direction of Constance Benson, MD, Cara Wilson, MD, and Robert Schooley, MD The clinical trials as well as preclinical activities are being sponsored by a grant from the National Institutes of Health (NIH).

The initial phase I/II trial is a double-blind, placebo-controlled, dose- escalation study and will include approximately forty patients. The primary objective of this study is to determine the safety of the EP HIV-1090 vaccine. Secondary objectives are to determine the immunogenicity of the vaccine or the level of the immune response as measured by the quantity and breadth of cytotoxic T-cells (CTL) generated. Completion of the phase I/II trial and final data analysis are expected in late 2003.

Epimmune's EP HIV-1090 lead vaccine candidate is composed of 21 unique CTL epitopes, or protein fragments, which were selected from conserved regions of multiple HIV virus proteins using Epimmune proprietary processes. The use of conserved epitopes is expected to make it harder for the virus to develop mutation ...