Tanox Conducts Meeting With Food and Drug Administration Regarding Its HIV/AIDS Antibody, TNX-355
04 August 2006 - 8:45AM
PR Newswire (US)
HOUSTON, Aug. 3 /PRNewswire-FirstCall/ -- Tanox, Inc. (NASDAQ:TNOX)
has conducted a meeting with the Food and Drug Administration (FDA)
to discuss clinical-trial results and continued development of
TNX-355, the company's antibody being investigated for the
treatment of HIV/AIDS. While the FDA indicated that TNX-355 has
demonstrated therapeutic potential in clinical testing, an
additional dose-finding study will be needed. The FDA also
indicated that a dose-finding trial, if appropriately designed and
successful, could serve as one of the pivotal studies for a
Biologics License Application (BLA) submission. The company expects
to continue its discussions with the Agency regarding
clinical-trial design options over the next several weeks. The
outcome of these discussions may delay the company's anticipated
submission of a BLA. "Despite the potential delay in our
development program, we are encouraged that the FDA has recognized
the therapeutic potential of TNX-355 in HIV treatment-experienced
patients," said Danong Chen, president and chief executive officer.
"This patient population has a limited number of treatment
alternatives, and we continue to believe that TNX-355 could be a
valuable option for patients. We plan to work closely with the
Agency on a clinical- trial design to identify the appropriate dose
and dosing regimen, and a clear path forward to a BLA." The company
intends to provide additional information about its development
plan and timing of future clinical trials for TNX-355 later this
quarter. About TNX-355 TNX-355 is a humanized monoclonal antibody
and part of the viral-entry inhibitor class of HIV therapies.
TNX-355, which is administered intravenously, is distinct from
other entry inhibitors in that it binds to CD4 receptors -- the
primary target of HIV infection. Since TNX-355 blocks HIV entry at
a step prior to the co-receptor interaction, it is "co-receptor
tropism independent," with the ability to block both CCR5- and
CXCR4-tropic viruses. The blockade presented by TNX-355 also does
not depend on targeting a mutation-prone viral protein. TNX-355 has
a Fast Track designation from the FDA. About Tanox, Inc. Tanox is a
biotechnology company specializing in the discovery and development
of monoclonal antibodies. The company develops innovative
biotherapeutics for the treatment of immune-mediated diseases,
inflammation, infectious disease and cancer. Tanox's first-approved
drug, Xolair(R) (omalizumab), is the first antibody approved to
treat moderate-to-severe confirmed allergic asthma. Xolair was
developed in collaboration with Genentech, Inc. and Novartis Pharma
AG and is approved for marketing in the United States, Canada and
major European countries. Tanox is based in Houston and has a
manufacturing facility in San Diego. Additional corporate
information is available at http://www.tanox.com/ . This news
release contains forward-looking statements regarding the potential
for TNX-355 as a treatment for HIV-1-infected patients and the
anticipated timing and design of further clinical studies of
TNX-355. These statements are based on Tanox's current beliefs and
expectations, and are subject to risks and uncertainties that could
cause actual results to differ materially. The therapeutic
potential of TNX-355 as a treatment for HIV-1- infected patients is
subject to the risks inherent in drug development. The conduct or
timing of any future trials can depend on many factors, including
our discussions with the FDA, whether we choose to partner the
program, and availability of sufficient quantities of
clinical-trial material. Success in early stage clinical trials
does not ensure that later-stage or larger-scale clinical trials
will be successful, and the results achieved in later-stage trials
may not be sufficient to meet applicable regulatory standards.
Problems or delays may arise during clinical trials or in the
course of developing, testing or manufacturing drugs. For more
detailed information on the risks and uncertainties associated with
Tanox's drug development and other activities, see Tanox's periodic
reports filed with the Securities and Exchange Commission. The
Tanox logo is a registered trademark with the U.S. Patent and
Trademark Office.
http://www.newscom.com/cgi-bin/prnh/20050207/TNOXLOGO DATASOURCE:
Tanox, Inc. CONTACT: Steve Sievert of Tanox, Inc., +1-713-578-4211,
or Web site: http://www.tanox.com/
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