Tanox Initiates Phase 1 Clinical Trial Evaluating TNX-650 for Treatment of Asthma
25 10월 2006 - 8:00PM
PR Newswire (US)
HOUSTON, Oct. 25 /PRNewswire-FirstCall/ -- Tanox, Inc.
(NASDAQ:TNOX) has begun dosing a Phase 1 clinical trial of TNX-650,
a humanized monoclonal antibody being evaluated as a potential
treatment for moderate-to-severe asthma. The trial is a randomized,
double-blind, placebo-controlled, dose- escalation study of the
safety, tolerability and pharmacokinetics of single doses of
TNX-650 in healthy volunteers. A total of 32 subjects will be
enrolled in four cohorts in the study, which is being conducted at
a single site in the U.S. TNX-650 targets Interleukin 13 (IL-13).
Preclinical studies indicate that IL-13 is a key mediator of asthma
responses, including airway inflammation, obstruction and
hyper-reactivity. TNX-650, which has a mechanism of action unique
from currently available asthma treatments, has the potential to be
a therapeutic option for patients whose disease is not currently
well controlled and for non-allergic asthmatics. "Despite
therapeutic advances, many asthmatics are still unable to
effectively control their symptoms," said Danong Chen, Ph.D.,
president and chief executive officer of Tanox. "IL-13 plays a
critical role in the development of asthma, and TNX-650 has been
shown to be effective in blocking IL-13 function. If successful in
the clinic, we believe TNX-650 could be another treatment option to
help patients better manage their disease." Moderate-to-severe
asthmatics comprise approximately 35 percent of the estimated 17
million asthma patients in the U.S. Tanox is also evaluating the
anti-IL-13 effect of TNX-650 as a potential treatment for Hodgkin's
lymphoma in an ongoing Phase 1 clinical trial. About Tanox, Inc.
Tanox is a biotechnology company specializing in the 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-650 as a treatment for asthma. 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 ability of Tanox to fully enroll the TNX-650 Phase
1 clinical trial could be delayed due to the availability of
subjects to participate in the trial. The therapeutic potential of
TNX-650 as an asthma treatment is subject to risks inherent in drug
development. Neither published data nor preclinical results offer
assurance that TNX-650 will be an effective treatment in humans.
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.
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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