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PEHRG214 - Phase Two Trial

Virionyx is preparing to conduct Phase II trials of PEHRG214 commencing Q2 2006. ... trial objective is to clearly establish the efficacy of PEHRG214 as well as reaffirming the continuing safety of the therapy. Virionyx expects Phase II results to significantly exceed the FDA minimum standards for fast track pivotal (approval) trial consideration.

Results: PE HRG214 strongly neutralized a diverse range of primary HIV-1 isolates, encompassing subtypes A to E and both CCR5 and CXCR4 phenotypes. Neutralization was enhanced by the presence of complement. PEHRG214 also induced complement-mediated lysis of all HIV-1 isolates tested, and recognized or cross-reacted with a number of host cell proteins. Lysis was abrogated by adsorption with T and/or B cells expressing GPI-linked proteins, but not by GPI-deficient B cells or red blood cells.

Conclusions: PEHRG214 was found to potently neutralize and lyse HIV-1 particles. Bytargeting host cell proteins present in the viral envelope, which are conserved among all strains tested, PEHRG214 potentially opens up a highly novel means of eliminating
circulating virus in infected individuals.


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