ADVENTRX Pharmaceuticals Receives FDA Clearance for HIV Viral Entry Inhibitor to Begin Phase Ib/IIa Human Clinical Trial
April 15 2004 - 9:30AM
PR Newswire (US)
ADVENTRX Pharmaceuticals Receives FDA Clearance for HIV Viral Entry
Inhibitor to Begin Phase Ib/IIa Human Clinical Trial SAN DIEGO,
April 15 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc.
(BULLETIN BOARD: AVRX) announced today that the Investigational New
Drug Application (IND) for its HIV-1 entry inhibitor,
BlockAide/CR(TM), received FDA clearance to begin a Phase Ib/IIa
human clinical trial. The trial will assess safety,
pharmacokinetics and effect on viral load of BlockAide/CR in HIV-1
positive individuals with evidence of increasing viral load despite
treatment with other antiretroviral therapy. "We were encouraged by
preclinical studies that showed BlockAide/CR was safe and active
against multiple HIV strains," commented Joan M. Robbins, Ph.D.,
ADVENTRX Chief Technical Officer. "With toxicities associated with
current treatment regimens and viral resistance continuing to be a
major problem, there is an indisputable need for alternative
treatment options. We are hopeful that BlockAide/CR can address
these issues." BlockAide/CR is a synthetic 15 amino acid peptide,
which mimics a portion of HIV-1 that is responsible for entry into
the immune system cell. The BlockAide/CR peptide binds to immune
system cells, preventing co-receptor interaction necessary for HIV
fusion and entry. Since BlockAide/CR binds to immune system cells
to inhibit viral entry rather than binding directly to HIV,
BlockAide/CR may be less susceptible to problems with viral
resistance associated with other viral entry inhibitors and HAART
(highly active antiretroviral therapy) drugs. The clinical study is
planned to be conducted at the VA San Diego Healthcare System under
the direction of David J. Looney, M.D., Principal Investigator,
Veterans Medical Research Foundation. Drug safety and effects on
HIV viral load and CD4+ T cell count will be determined. About
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 on cancer and antiviral research to launch
products that either extend the usefulness of current therapies or
replace marginal therapies with new approaches to treatment. More
information on ADVENTRX and BlockAide/CR can be found on the
Company's website at http://www.adventrx.com/. 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. Contacts: The Ruth Group
Investors: Stephanie Carrington 646-536-7017 Media: Cynthia Isaac,
Ph.D. 646-536-7028 Study related: Cellia Habita, M.D., Ph.D. VP,
Medical and Clinical Affairs ADVENTRX Pharmaceuticals 858-271-9671
DATASOURCE: ADVENTRX Pharmaceuticals, Inc. CONTACT: Stephanie
Carrington, The Ruth Group, +1-646-536-7017, or Media, Cynthia
Isaac, Ph.D., +1-646-536-7028, both for ADVENTRX; or Cellia Habita,
M.D., Ph.D., VP, Medical and Clinical Affairs, ADVENTRX
Pharmaceuticals, +1-858-271-9671 Web site: http://www.adventrx.com/
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