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IND Filed for HIV Viral Entry Inhibitor
SAN DIEGO, March 4 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (BULLETIN BOARD: AVRX) announced today that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to begin its clinical program for BlockAide/CR™, a peptide-based drug that is representative of the new "fourth modality" of HIV therapeutics that works by blocking viral entry and infection of human immune system cells.
"Viral resistance and toxicity continue to be major challenges in the treatment of HIV patients on HAART (highly active antiretroviral therapy)," said Dr. Joan Robbins, Chief Technical Officer of ADVENTRX. "We plan to test our drug in patients with evidence of HIV replication despite ongoing HAART. Our Phase Ib/IIa trial is a multi-dose trial that is designed to examine the safety, pharmacokinetics and effect on viral load of BlockAide/CR."
BlockAide/CR use in humans is intended to inhibit HIV infection during an early and lengthy step in the infection process. In contrast, HAART drugs are used to interrupt viral replication after HIV has gained entry into immune system cells. Preclinical testing of BlockAide/CR demonstrated efficacy in HIV-infected human cells and in non-human primates challenged with SHIV (simian human immunodeficiency virus). Furthermore, since BlockAide/CR binds to immune system cells rather than binding directly to HIV to inhibit viral entry, BlockAide/CR may be less susceptible to problems associated with viral resistance that have plagued other viral entry inhibitors and HAART drugs.
ADVENTRX Pharmaceuticals Inc.