Adventrx Pharmaceuticals Inc announced that after completing manufacturing of its viral entry inhibitor for HIV, known as BlockAide/CR, it has signed an agreement with Synteract Inc, a Contract Research Organization (CRO) headquartered in Carlsbad, California, to coordinate its Phase Ib/IIa human clinical trial, which is scheduled to begin in September.

"We are pleased to be working with Synteract as our CRO for this initial human clinical trial of BlockAide/CR," said Dr. Joan Robbins, Adventrx Pharmaceuticals' Chief Technical Officer. "Synteracts' comprehensive capabilities, from protocol development and site management to data collection, electronic submissions, and safety surveillance will give us all the necessary tools to properly and rapidly implement the study of our drug in HIV infected individuals."

BlockAide/CR is a synthetic peptide drug, based upon the structure of the V3 loop of HIV, which the virus uses to bind to cell surface lipids as part of its infection process before viral fusion takes place. BlockAide/CR competitively inhibits the interaction of the V3 loop with host cell lipids, which is a common mechanism for entry and infection of diverse HIV-1 strains, and thus prevents infection of treated immune system cells.

In preclinical development, BlockAide/CR was administered in daily doses to determine the effectiveness of this drug against acute infection with SHIV (simian human immunodeficiency virus) in an animal model. Viral load decreased 100-fold after approximately two weeks of treatment, with no observed toxicity. Based upon the success of this efficacy testing, including toxicity studies in four non-human animal models, and the receipt of newly manufactured drug product for human testing, the Company is finalizing its IND (Investigation New Drug) application for submission to FDA to gain approval to begin trials with Synteract as it designated CRO.