ADVENTRX Pharmaceuticals Files IND for Phase Ib/IIa Trials for HIV Viral Entry Inhibitor
March 04 2004 - 9:35AM
PR Newswire (US)
ADVENTRX Pharmaceuticals Files IND for Phase Ib/IIa Trials 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(TM), a peptide-based drug that is
representative of the new "fourth modality" of HIV therapeutics
that works by blocking viral entry andinfection 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 ADVENTRX Pharmaceuticals
Inc. is a biopharmaceutical research and development company whose
business strategy is to commercialize leading edge medical research
through licensing agreements with prominent universities and
research institutions. The Company focuses its energy in cancer and
antiviral research to launch products that either extend the
usefulness of current therapies or replace marginal therapies with
new approaches to treatment. This press release contains
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities LitigationReform Act of 1995.
Such statements are made based on management's current expectations
and beliefs. Actual results may vary from those currently
anticipated based upon a number of factors, including uncertainties
inherent in the drug development process, the timing and success of
clinical trials, the validity of research results, and the receipt
of necessary approvals from the United States Food and Drug
Administration. The Company undertakes no obligation to release
publicly any revisions, which may be made to reflect events or
circumstances after the date hereof. Contact: The Ruth Group
Investors: Stephanie Carrington 646-536-7017 Media: Cynthia Isaac,
Ph.D. 646-536-7028 DATASOURCE: ADVENTRX Pharmaceuticals Inc.
CONTACT: Investors, Stephanie Carrington, +1-646-536-7017, or
Media, Cynthia Isaac, Ph.D., +1-646-536-7028, both of The Ruth
Group for ADVENTRX Pharmaceuticals Inc.
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