No Safety Issues Cited During Planned Interim Review
HOUSTON, Sept. 13 /PRNewswire-FirstCall/ -- An independent Data Safety
Monitoring Board (DSMB) has reviewed a planned interim safety analysis of
Tanox, Inc.'s (Nasdaq: TNOX) Phase 2 clinical trial of TNX-355 for treatment
of the human immunodeficiency virus (HIV) and has recommended continuation of
the trial.
The DSMB examined all critical safety data specified in the study's
protocol. Reliable information was made available for review after the last
randomized, dosed patient reached the 20-week time point of the 48-week study.
Pre-specified stopping criteria, based on a group sequential test for
monitoring immunosuppressive effects, were not met and no other safety
concerns were cited. In addition, the DSMB did not find cause to change the
planned conduct of the trial or to alter the study's current monitoring plan.
The Phase 2 study is a three-arm, double-blind, placebo-controlled trial
evaluating the safety and efficacy of TNX-355, as assessed by viral load
reduction. The study, which enrolled 82 patients, is statistically designed
to compare the effect of two different dose schedules of TNX-355 added to
optimized background therapy (OBT) versus OBT plus placebo in treatment-
experienced HIV-infected patients.
The primary endpoint for the Phase 2 trial is a significant reduction in
viral load levels between either of the active arms versus the OBT control arm
at 24 weeks. A significant viral load reduction is defined as > 0.5 log10
cells/mL. Preliminary efficacy results from the trial are scheduled to be
announced in the fourth quarter of 2005.
TNX-355 is a humanized, non-immunosuppressive anti-CD4 monoclonal antibody
that blocks the ability of HIV to enter CD4-positive cells. TNX-355 received
Fast Track Status from the U.S. Food and Drug Administration in 2003.
About Tanox, Inc.
Tanox is a biotechnology company specializing in the discovery and
development of biotherapeutics based on monoclonal antibody technology. The
company develops innovative therapeutic agents for the treatment of immune-
mediated diseases, infectious disease, inflammation and cancer. Tanox's lead
investigational therapy, TNX-355, is a humanized, anti-CD4 monoclonal antibody
to treat HIV and AIDS. TNX-355 received Fast Track Status from the U.S. Food
and Drug Administration in 2003 and is currently in Phase 2 clinical testing.
Tanox's first-approved drug, Xolair(R) (omalizumab), is the first anti-
immunoglobulin E (anti-IgE) antibody to be brought to market. Xolair was
developed in collaboration with Genentech, Inc. and Novartis Pharma AG and was
approved for marketing in the United States in 2003 for adult and adolescent
patients with moderate-to-severe, confirmed allergic asthma. Tanox is based
in Houston, Texas and maintains a manufacturing facility in San Diego,
California. 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. 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 timing of announcement of results from the Phase 2 study is
subject to the ability of Tanox to collect and analyze the interim data from
the Phase 2 study after all patients have reached the 24-week time point of
the study. In addition, the absence of safety concerns after 16 weeks of
treatment in patients does not ensure that there will be no safety concerns
after 48 weeks of treatment, or that safety issues will not be identified in
larger-scale clinical trials. The therapeutic potential of TNX-355 as a
treatment for HIV-1-infected patients is subject to the risks inherent in drug
development. Success in early stage clinical trials does not ensure that
later-stage or larger-scale clinical trials will be successful. 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.
SOURCE Tanox, Inc.
 back to top
Related links:
http://www.tanox.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/20050207/TNOXLOGO
PRN Photo Desk,photodesk@prnewswire.com
CONTACT:
Steve Sievert of Tanox, Inc.,
+1-713-578-4211, or ssievert@tanox.com
|
