SAN DIEGO, July 22 /PRNewswire-FirstCall/ --
ADVENTRX Pharmaceuticals, Inc. (OTC Bulletin Board: AVRX) announced today that
after completing manufacturing of its viral entry inhibitor for HIV, known as
BlockAide/CR(TM), 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
"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.
Established in 1995, Synteract is a privately held, full-service contract
research organization, dedicated to meeting the various needs of
biotechnology, biomedical, pharmaceutical, and drug industry firms. Based in
the Carlsbad, CA, with a branch office in Pennsylvania, the Company provides
expertise in a wide range of therapeutic areas and maintains a wealth of
knowledge in oncology, ophthalmology, HIV, erectile dysfunction,
cardiovascular disease, and pain. Since 2000, it has been a key development
shop for web, wireless and voice data solutions that speed the completion of
clinical trials and assist in access to clinical trials information. This
includes technologies such as electronic data capture (EDC), interactive voice
response systems (IVRS), and automated safety tracking and reporting.
About ADVENTRX Pharmaceuticals
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 Litigation Reform
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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
Web Site: http://www.adventrx.com