Tanox Announces Start of Anti-IgE Clinical Trial
Tanox Announces Start of Anti-IgE Clinical Trial in Severe Peanut Allergy
HOUSTON, July 13 /PRNewswire/ -- Tanox, Inc. today announced the start of
a Phase I/II clinical trial in severe peanut allergy with Hu-901, an
monoclonal antibody produced by Tanox. Tanox is independently evaluating
Hu-901 for the treatment of IgE-mediated allergic diseases outside the
clinical focus of rhuMab-E25 anti-IgE, which is being jointly developed in
collaboration with Genentech and Novartis.
The Phase I/II trial will take place under an Investigational New Drug
Application filed by Tanox with the U.S. Food and Drug Administration.
Volunteers for the study will have a history of severe allergic reactions
peanuts. About 2% of U.S. adults report that they have had reactions to
peanuts or other nuts, and peanut allergies are the most common cause of
related anaphylaxis and death.
"We have long believed that the potential of anti-IgE should be explored
beyond the respiratory allergies, allergic rhinitis and allergic asthma,"
Dr. Nancy Chang, President of Tanox, Inc. "Although our initial idea was
test Hu-901 first in atopic dermatitis, our clinical consultants suggested
allergic reactions to peanuts because of the life-threatening risk to
with anaphylactic allergic reactions to peanuts. We believe our study will
provide important insight into the usefulness of Hu-901 anti-IgE in
food allergy, as well as other IgE-mediated allergic diseases".
Different forms of peanuts are hidden in many foods, including candy and
baked goods, and therefore it is very difficult to avoid eating peanuts.
"Many people who have severe allergic reactions to peanuts die in
or on the way to the hospital," said Dr. Donald Leung, Professor and Head
the Division of Pediatric Allergy-Immunology, the National Jewish Medical
Research Center, Denver, Colorado, one of the investigators for the study.
"We have wanted to do a trial with anti-IgE in peanut allergic patients for
long time, to study its ability to prevent or reduce reactions to ingested
allergens and to see if it will help people tolerate accidental ingestion
small amount of peanuts. We are pleased that Tanox is willing to sponsor
During the study, individuals who have allergic reactions to peanut will
be treated with Hu-901 and will then be tested to see if their sensitivity
peanut has been reduced and they can eat more peanuts before a reaction
occurs. "If anti-IgE reduces allergic reactions to peanuts," said Dr. Hugh
Sampson, Professor, Department of Pediatric, Mount Sinai Medical Center,
York City, "it will be important to do further studies to investigate its
potential benefit for patients with allergic reactions due to multiple
drugs or inhaled allergens." Dr. Sampson is also an investigator in the
Tanox, Inc., incorporated in 1986, is a biotechnology research and
development company in Houston, Texas. Tanox is a leader in the
of novel monoclonal antibody based treatments for diseases involving or
affecting the human immune system. Tanox holds patents around the world
covering the use of anti-IgE antibodies for the treatment of IgE-mediated
diseases. Tanox is collaborating in the development of two anti-IgE
antibodies with Novartis Pharma AG and Genentech, Inc., with the lead
from such collaboration, rhuMab-E25, now in late Phase III clinical trials.
Tanox has additional innovative monoclonal antibodies in development for
treatment of inflammatory and infectious diseases and cancer. Additional
information about Tanox is available at [url="http://www.tanox.com."]http://www.tanox.com.[/url]
For further information, contact:
David Duncan, Vice President of Finance & CFO, or
David Anderson, Special Projects Tel: 713-664-2288
Statements in the Company's press releases, reports and information
disclosures about its products, including anti-IgE, and their prospects
development and commercialization, other than statements of historical
are forward-looking statements and are subject to a number of uncertainties
that may cause actual events or results to differ materially from the
statements made. Factors that could affect actual events or results
risks associated with the success of clinical trials and research and
development progress, the regulatory approval process, competitive
and the strength of Tanox's patent portfolio. Risks that may affect the
Company include timelines that are subject to change, the unpredictability
clinical trial results and the unpredictability of decisions by the FDA and
other regulatory agencies, including decisions regarding whether sufficient
data and compliance with other requirements exist to support product
SOURCE Tanox, Inc.
CO: Tanox, Inc.; Novartis Pharma AG; Genentech, Inc.