CLINICAL TRIAL STARTS FOR TREATMENT OF PNT ALLERGY

Posted on: Tue, 07/13/1999 - 10:57pm
brenda's picture
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Joined: 01/22/1999 - 09:00

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 anti-IgE
monoclonal antibody produced by Tanox. Tanox is independently evaluating
Hu-901 for the treatment of IgE-mediated allergic diseases outside the
current 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 to
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
food-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,"
said Dr. Nancy Chang, President of Tanox, Inc. "Although our initial idea
was to test Hu-901 first in atopic dermatitis, our clinical consultants
suggested allergic reactions to peanuts because of the life-threatening risk
to patients with anaphylactic allergic reactions to peanuts. We believe our
study will provide important insight into the usefulness of Hu-901 anti-IgE
in treating 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
restaurants or on the way to the hospital," said Dr. Donald Leung, Professor
and Head of the Division of Pediatric Allergy-Immunology, the National
Jewish Medical and 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 a
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 of
a small amount of peanuts. We are pleased that Tanox is willing to sponsor
this study".

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
to 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, New
York City, "it will be important to do further studies to investigate its
potential benefit for patients with allergic reactions due to multiple
foods, drugs or inhaled allergens." Dr. Sampson is also an investigator in
the study.

Tanox, Inc., incorporated in 1986, is a biotechnology research and
development company in Houston, Texas. Tanox is a leader in the development
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
product 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]

SOURCE Tanox, Inc.
Web Site: [url="http://www.tanox.com"]http://www.tanox.com[/url]

Posted on: Wed, 07/14/1999 - 11:43am
dhumphries's picture
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Joined: 02/02/1999 - 09:00

pBrenda,/p
pThanks so much for this post. It really picked me up, as I have had a not so good day today./p
pStay Safe, Deb/p

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