Tanox Announces Start of Anti-IgE Clinical Trial

Posted on: Tue, 07/13/1999 - 3:09pm
Chris PeanutAllergy Com's picture
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Joined: 04/25/2001 - 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]

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
for
development and commercialization, other than statements of historical
fact,
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
include
risks associated with the success of clinical trials and research and
development progress, the regulatory approval process, competitive
products,
and the strength of Tanox's patent portfolio. Risks that may affect the
Company include timelines that are subject to change, the unpredictability
of
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
licensure.

SOURCE Tanox, Inc.

CO: Tanox, Inc.; Novartis Pharma AG; Genentech, Inc.

ST: Texas

IN: MTC

------------------
Stay Safe

[email]"Chris@PeanutAllergy.Com"[/email]

Posted on: Tue, 07/13/1999 - 9:19pm
carrie's picture
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Joined: 05/15/1999 - 09:00

pMy son's allergist says that he is a bit nervous about anti-IgE therapy because he is unsure of it's effects on the body's immune system. He seems to feel that this therapy may not be the answer.br /
Has anyone heard such thoughts from their physicians? I would like to hear any responses you may have.br /
Thanks and stay safe today,br /
carrie/p

Posted on: Tue, 07/13/1999 - 10:59pm
anonymous's picture
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Joined: 05/28/2009 - 16:42

pCarrie, in response to your question, yes, I have also talked with an allergist who indicated that the anti-IGE antibody is of concern for children due to their immune system not being fully developed. The clinical trials are geared for adults. I believe most reasearch work starts with adults to show safety and efficacy. /p
p[This message has been edited by Mary (edited July 14, 1999).]/p

Posted on: Wed, 07/14/1999 - 1:38pm
Rhonda's picture
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Joined: 04/21/1999 - 09:00

pI as well share your concerns - however I am thrilled that the research is underway and the clinical tests are being done. It may be a long road but at least we are on that road. I hope and pray for a miracle drug and have great faith in what can be accomplished. My monther suffers from a heard condition, a number of years ago she would not have had the prospects she has today due to medical advances. Clinical studies are at least a move towards a solution.br /
Hats off to them and to all the brave Peanut allergic individuals who are particpating in the study./p

Posted on: Wed, 07/14/1999 - 7:16pm
Noreen's picture
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Joined: 01/24/1999 - 09:00

pPlease be sure and send your thanks to Tanox for taking this one on. The contact person on the Tanox web site is:/p
pDavid Duncan. Jr.br /
VP of Finance and CFObr /
Tanox, Inc.br /
10301 Stella Linkbr /
Houston, Texas 77025-5497br /
(713) 664-2288br /
(713) 664-8914 FAXbr /
[email]dduncan@tanox.com[/email]/p
pThe more letters/emails he receives from us, the better./p
pNoreen/p

Posted on: Thu, 07/15/1999 - 7:31am
Noreen's picture
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Joined: 01/24/1999 - 09:00

pI received a clarification today from the CFO on how the HU-901 antibody works. /p
p"Just to clarify the potential use of HU-901 in a clinical setting, HU-901 isbr /
not actually a vaccine, but a monoclonal antibody that binds to IgE andbr /
prevents the Ige from initiating the allergic response. Assuming thebr /
clinical trials are successful, the use of HU-901 in clinical practice wouldbr /
be for the patient to go to the Doctor every three or four weeks and receivebr /
an injection of HU-901. The HU-901 would then prevent or reduce thebr /
consequences of the unintended ingestion of peanuts by the patient. Sincebr /
HU-901 is not a vaccine, the patient would need to receive an injectionbr /
every three or four weeks to maintain enough antibody in their system tobr /
control the allergic response."/p
pNoreen/p

Posted on: Thu, 07/22/1999 - 3:38pm
Chris PeanutAllergy Com's picture
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Joined: 04/25/2001 - 09:00

pWe have been in contact with Dr. Hugh Sampson in the Division of Allergy...at the Mt. Sinai Hospital in New York (U.S.)./p
pHe is now ready for individuals to participate in a placebo controlled study, which is ready to be conducted./p
pTo participate individuals must be 18 to 60 years old and have a definitive history of an allergic reaction to peanut. If the individuals IGE level are over 500 then they will not qualify for the first round. (ru per ml.)br /
He is aware that many people do not know their level, so if you do not know your level you can still contact them if you are interested in taking part in the study./p
pYou must be available to make 7 visits to the Mt. Sinai in New York (U.S.) over a 6 month period, starting as soon as possible. There will be an initial screening including a double blind oral challenge (he told me there would be an IV etc. and the person would be challenged only until a reaction occurred).br /
Then there will be an injection once a month for four months.br /
Then he informed me there would be a "re-challenge"./p
pMany of you have informed me to contact you if there was such a study, which you could participate in. /p
p Contact the Division of Allergy at the Mt. Sinai Hospital at 212-241-5548. The office secretary will take some information and they will contact you./p
pThis research is very exciting news and are glad that PeanutAllergy.Com is able to assist!/p
p------------------br /
Stay Safe/p
p [email]"Chris@PeanutAllergy.Com"[/email] /p
p[This message has been edited by Chris PeanutAllergy Com (edited July 30, 1999).]/p

Posted on: Mon, 12/13/1999 - 4:28am
Chris PeanutAllergy Com's picture
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Joined: 04/25/2001 - 09:00

pThis just e mailed to us from Dr. Sampson (I asked if he still needs more of our help to find volunteers!) Here is what he wrote:/p
p/p
pDear Chris,/p
pRecruitment for the study has been going very slowly. Only a few patients have been enrolled. We need as many volunteers as you can find. Thanks for your help./p
pHugh Sampson, M.D./p
pend of e mail/p
pIf you are interested in participating in THE study contact the Division of Allergy at the Mt. Sinai Hospital at 212-241-5548./p
pIf you know others who might be interested in participating let them know asap! /p
pHopefully this will lead to the cure we are all hoping for!/p
p------------------br /
Stay Safe,/p
p [email]"Chris@PeanutAllergy.Com"[/email]/p

Posted on: Mon, 12/13/1999 - 8:43am
LoriHuhn's picture
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Joined: 09/23/1999 - 09:00

pI would think that PA people would be lining up out the door...I can't believe that. I wish they were accepting kids, I would enroll my son (unless of course it's life-threatening). We need to get this going so we all can one day lead a normal life!/p

Posted on: Tue, 12/14/1999 - 2:05am
Mel's picture
Mel
Offline
Joined: 09/21/1999 - 09:00

pThere are adults that are involved in the testing. My husband and I were set to go to New York. (we live in Michigan) We had to askbr /
a lot of questions. His family memembers were not happy about him being tested. /p
pThe test does involve ingestion of peanut protein. Due to that fact and my husband's reaction history. Both Dr. Sampson and his doctor in Michigan said it was to dangerous for him to be a canidate for the testing./p
pThere is also the chance that because of the blind testing. The candidate may not be even receiving the Anti- IGE. So the person could ingest peanut protien and react./p
pSo yes the test could be life threating./p

Posted on: Mon, 12/27/1999 - 4:36am
Chris PeanutAllergy Com's picture
Offline
Joined: 04/25/2001 - 09:00

pDear Chris,/p
p In this study we are attempting to determine whether or notbr /
anti-IgE therapy will be effective in preventing anaphylacticbr /
reactions to peanuts. If it is effective in peanut allergic patients,br /
it is very likely that it will actually protect allergic patients frombr /
all food allergies./p
p The protocol is very stringent because the FDA will determinebr /
whether or not this drug will be approved based on this study.br /
Consequently patients must first be challenged to peanut to establishbr /
what dose of peanut will set off their allergic reaction. Oncebr /
symptoms develop, patients are given activated charcoal and treatedbr /
immedicately. This is done in the hospital with a nurse and physicianbr /
immediately available and emergency equipment at hand. Patients arebr /
carefully screened prior to the study with a complete physical exam,br /
blood work, EKG and pulmonary function studies. Once the challenge isbr /
completed, the patient goes on anti-IgE therapy for 4 months. Thisbr /
anti-IgE is the same type of treatment that was recently reported tobr /
be successful in treating asthma. After 4 months, the patients returnsbr /
and is rechallenged to determine whether they can tolerate morebr /
peanut. /p
p This is a double-blind placebo-controlled study, so one-fourth ofbr /
patients will receive placebo [i.e. a non-active drug]. Again, this isbr /
required by the FDA. Following the study, these people [and all studybr /
subjects] will be given anti-IgE at no charge until the drug isbr /
approved by the FDA. The drug will not be available to the generalbr /
population until it is approved by the FDA. /p
p We are very optimistic about this medication as a means ofbr /
protecting patients with multiple food allergies, until safe andbr /
effective vaccines can be developed. We are very anxious to get morebr /
patients into this study so that we can start a second study inbr /
children, if this adult study looks promising. In the children'sbr /
study, we will not have to challenge the patients with peanut beforebr /
starting the drug./p
p Please let me know if you have any other questions. Best regards./p
p Hugh Sampson, M.D./p
p--------------------------------/p
pEnd/p
pThis is a note to those of us who are reading this and have not yet become involved inbr /
helping. We can do a lot as a group, we can pool our resources to promote peanut allergybr /
and help us to get the word out there about things such as this study and the need forbr /
volunteers. JOIN IN! WE ARE WORKING AS A (PEANUT ALLERGY)br /
COMMUNITY TO MAKE A BIG DIFFERENCE! JOIN AS A MEMBER, SEND Abr /
DONATION (VERY IMPORTANT!) AND IF YOU CAN, VOLUNTEER SOMEbr /
TIME AS WELL! IF YOU HAVE ANY TIME TO VOLUNTEER, LET US KNOWbr /
YOUR SKILLS, TIME YOU CAN GIVE ETC./p
pE MAIL THE ADDRESS BELOW!/p
p------------------br /
Stay Safe,/p
p [email]"Chris@PeanutAllergy.Com"[/email]/p

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