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 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


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


On Jul 14, 1999

My 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. Has anyone heard such thoughts from their physicians? I would like to hear any responses you may have. Thanks and stay safe today, carrie

On Jul 14, 1999

Carrie, 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.

[This message has been edited by Mary (edited July 14, 1999).]

On Jul 14, 1999

I 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. Hats off to them and to all the brave Peanut allergic individuals who are particpating in the study.

On Jul 15, 1999

Please be sure and send your thanks to Tanox for taking this one on. The contact person on the Tanox web site is:

David Duncan. Jr. VP of Finance and CFO Tanox, Inc. 10301 Stella Link Houston, Texas 77025-5497 (713) 664-2288 (713) 664-8914 FAX [email]dduncan@tanox.com[/email]

The more letters/emails he receives from us, the better.


On Jul 15, 1999

I received a clarification today from the CFO on how the HU-901 antibody works.

"Just to clarify the potential use of HU-901 in a clinical setting, HU-901 is not actually a vaccine, but a monoclonal antibody that binds to IgE and prevents the Ige from initiating the allergic response. Assuming the clinical trials are successful, the use of HU-901 in clinical practice would be for the patient to go to the Doctor every three or four weeks and receive an injection of HU-901. The HU-901 would then prevent or reduce the consequences of the unintended ingestion of peanuts by the patient. Since HU-901 is not a vaccine, the patient would need to receive an injection every three or four weeks to maintain enough antibody in their system to control the allergic response."


On Jul 22, 1999

We have been in contact with Dr. Hugh Sampson in the Division of Allergy...at the Mt. Sinai Hospital in New York (U.S.).

He is now ready for individuals to participate in a placebo controlled study, which is ready to be conducted.

To 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.) 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.

You 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). Then there will be an injection once a month for four months. Then he informed me there would be a "re-challenge".

Many of you have informed me to contact you if there was such a study, which you could participate in.

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.

This research is very exciting news and are glad that PeanutAllergy.Com is able to assist!

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


[This message has been edited by Chris PeanutAllergy Com (edited July 30, 1999).]

On Dec 13, 1999

This 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:


Dear Chris, Recruitment 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. Hugh Sampson, M.D.

>>>end of e mail

If you are interested in participating in THE study contact the Division of Allergy at the Mt. Sinai Hospital at 212-241-5548.

If you know others who might be interested in participating let them know asap!

Hopefully this will lead to the cure we are all hoping for!

------------------ Stay Safe,


On Dec 13, 1999

I 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!

On Dec 14, 1999

There 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 ask a lot of questions. His family memembers were not happy about him being tested.

The 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.

There 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.

So yes the test could be life threating.

On Dec 27, 1999

Dear Chris, In this study we are attempting to determine whether or not anti-IgE therapy will be effective in preventing anaphylactic reactions to peanuts. If it is effective in peanut allergic patients, it is very likely that it will actually protect allergic patients from all food allergies. The protocol is very stringent because the FDA will determine whether or not this drug will be approved based on this study. Consequently patients must first be challenged to peanut to establish what dose of peanut will set off their allergic reaction. Once symptoms develop, patients are given activated charcoal and treated immedicately. This is done in the hospital with a nurse and physician immediately available and emergency equipment at hand. Patients are carefully screened prior to the study with a complete physical exam, blood work, EKG and pulmonary function studies. Once the challenge is completed, the patient goes on anti-IgE therapy for 4 months. This anti-IgE is the same type of treatment that was recently reported to be successful in treating asthma. After 4 months, the patients returns and is rechallenged to determine whether they can tolerate more peanut. This is a double-blind placebo-controlled study, so one-fourth of patients will receive placebo [i.e. a non-active drug]. Again, this is required by the FDA. Following the study, these people [and all study subjects] will be given anti-IgE at no charge until the drug is approved by the FDA. The drug will not be available to the general population until it is approved by the FDA. We are very optimistic about this medication as a means of protecting patients with multiple food allergies, until safe and effective vaccines can be developed. We are very anxious to get more patients into this study so that we can start a second study in children, if this adult study looks promising. In the children's study, we will not have to challenge the patients with peanut before starting the drug. Please let me know if you have any other questions. Best regards. Hugh Sampson, M.D.



This is a note to those of us who are reading this and have not yet become involved in helping. We can do a lot as a group, we can pool our resources to promote peanut allergy and help us to get the word out there about things such as this study and the need for volunteers. JOIN IN! WE ARE WORKING AS A (PEANUT ALLERGY) COMMUNITY TO MAKE A BIG DIFFERENCE! JOIN AS A MEMBER, SEND A DONATION (VERY IMPORTANT!) AND IF YOU CAN, VOLUNTEER SOME TIME AS WELL! IF YOU HAVE ANY TIME TO VOLUNTEER, LET US KNOW YOUR SKILLS, TIME YOU CAN GIVE ETC.


------------------ Stay Safe,


On Jan 5, 2000

Regarding the clinical trials which are underway, anti-IgE has been used in clincal trials for asthma. Just recently an article was published in the NEJM regarding the use of anti-IgE in the treatment of moderate to severe asthma.

If one is interested in learning more about anti-IgE and its use in asthma, you can go to PubMed [url="http://www.ncbi.nlm.nih.gov/PubMed/"]http://www.ncbi.nlm.nih.gov/PubMed/[/url]

At this free site, one can just type in keywords that you are researching, such as "anti-IgE". Then abstracts(or summaries) of medical articles on Medline will appear. To obtain full text articles, one can either purchase them or go to a local medical school library look them up.

This site, PubMed,is your federal tax dollar at work for you!


On Jan 6, 2000

Anyone that is eligible should jump at the chance to participate in this study.

Dr. Sampson has an excellent reputation in the field of allergy and immunology research. His medical and scientific skills are of the highest quality. In addition, he is a remarkably kind and caring person. These qualities, superb professionalism and a genuine caring approach to his patients are too rare a combination.

I do not make such a recommendation or give such assurances lightly, but from direct personal experience.

In 1991-92, when my son was 2-3 years old, he was being tortured by severe atopic dermatitis. After being examined by the very best specialists available in the Washington, D.C. area (dermatology, allergy, immunology), not one of them could determine the cause or help ease my son's constant and debilitating suffering. We were desparate and, after many many attempts to diagnose his condition, we finally were referred to Dr. Sampson by Dr. Jay Slater, an immunologist at Children's Hospital. Essentially, Dr. Sampson was our last hope of finding out the cause of my son's torture and any possible way to treat his condition. At the time, Dr. Sampson was conducting a double blind NIH-funded study at John Hopkins University Medical Center involving children with very severe atopic dermatitis.

To shorten a much longer story, basically Dr. Sampson (and Dr. Slater) saved my son's life. After two years of extensive but fruitless efforts by many other well-meaning medical experts, many of whom had national reputations in their fields, it was Dr. Sampson that finally determined, through his research protocol, that my son had severe allergies, to many allergens, but most dramatically to peanuts, egg products, and dairy products. His honest and detailed assessment of my son's condition, and caring and patient approach to explaining our options, were immeasurably helpful; not only to treatment of my son's atopic dermatitis and, later, his severe asthma, but also for our entire family's understanding of why my son was suffering so and what we could do to help him.

My son is twelve now and leading a very normal life. Of course, we still must be very careful to avoid his dangerous allergens, and he uses an inhaler for the asthma. However, he is not only active, but a very skilled player in several sports (particularly soccer!). Dr. Sampson is directly responsible for my son's good health and the sanity and survival of my family.

Run, don't walk, to participate in Dr. Sampson's research study. If you have any doubts or concerns, read the Dec 27 posting above by Dr. Sampson describing the care and precautions that will be taken to ensure that the best medical attention is constantly and immediately present and available. If it is anything like that available to my son during his week-long in-patient double blind trial/challenges, it will be nothing short of amazing medical attention and care.

I have the utmost respect, and am profoundly grateful for the contributions that Dr. Sampson and his team have made. And I am happy that Dr. Sampson continues to find funding to do such critically needed research.

If you can participate in Dr. Sampson's research, please do so. I, my family, and particularly my son and everyone else that has now or ever will have an allergy, will benefit and be grateful.

Art Jeffers [email]ajeffers@aol.com[/email]

On Jan 9, 2000

As anti-IgE clinical trials are moving forward for peanut allergy, it is always good to educate ourselves and learn more about how the process of clinical research is done. This reference is from the National Institutes of Health, the nation's leading biomedical research facility in Bethesda, MD. It is called, "What is a Clinical Trial?" It is very clear and gives excellent information for becoming involved in clinical research trials and understanding the research process. [url="http://www.nih.gov/health/clintr.htm"]http://www.nih.gov/health/clintr.htm[/url]


On Mar 29, 2000

Chris (PeanutAllergy.com)

Do you have any updates on Dr. Sampson's study and recruitment progress?

On Apr 10, 2000

Is there a similar trial occuring in the UK??? My son BJ is 8 and is tortured by his multiple allergies - not just peanut but all tree nuts and sesame (to boot!).

Also - I assume the IgE vaccine would be non-specific and block the reaction to any allergen; not just Peanut....

Any further information would be gratefully received - especially from clinicians working in this field.......



On May 3, 2000

There's a very hopeful article on peanut allergy research at [url="http://www.the-scientist.com/yr2000/mar/latta_p1_000306.html"]http://www.the-scientist.com/yr2000/mar/latta_p1_000306.html[/url]

On May 3, 2000

Hi goodwisj,

My 9 yr old son is multiply allergic to all the ones you mentioned (re your son). His allegen levels are quite high so for most of the studies it would be too risky for him to try. He is in all the high risk catagories: asthma, severe apotic dermintis, and other food and environmental allergies. Do you live in the USA or the UK? I learned last month that Nabisco regular Ritz (in USA) does contain sesame and are changing label to reflect this.

My son has outgrown 4 of his food allergies last year and we hope he will outgrow strawberries, peaches and egg. I am looking forward to finding results on the sesame seed as his CAPRAST in 1998 to that was 15.4(highest his food allergist had ever seen to date) and last year it came down to 12. I keep hoping that he may outgrow this one even though I realize it is usually thought to be life-long allergy. I haven't been able to buy bread crumbs as they all have sesame seed or egg so I make them from his special homemade rolls/bread.

It is a challenge keeping multiply allergic child safe.

take care,



On May 3, 2000

Hi jsmom. Thanks for the link. It does gives us hope. Interesting article. Just wondering...do you subscribe to that magazine or you came across it on the net?

On May 4, 2000

Diane, I found the article on the web. As the mother of a 14 yr old with peanut and milk allergies I often do a general search on the web using an internet search engine. Another good way to find articles is on the NIH Medline at [url="http://igm.nlm.nih.gov/"]http://igm.nlm.nih.gov/[/url]

On May 23, 2000

I was wondering too if there was any further development with Dr. Sampson's clinical trials for the Hu-901 antibody. Did they get enough people to make the clinical trials viable? Is it underway? How long with the trial go on? When should results be published?


On Jun 13, 2000

Tanox, Inc. Receives Grant From The Peanut Foundation for Clinical Studies On Peanut Allergies

Pharmaceutical Company Conducting Patient Trials Across U.S.

HOUSTON, June 13 /PRNewswire/ -- Tanox, Inc. (Nasdaq: TNOX) and The Peanut Foundation today announced the presentation of a $95,000 grant from The Peanut Foundation in support of Tanox's on-going Phase I/II clinical trials of Tanox's drug candidate Hu-901 in the treatment of subjects with histories of severe allergic reactions to peanut products. Participants are currently being enrolled for trials at six locations in the United States, in Arkansas, California, Colorado, Massachusetts, Minnesota, and New York.

Hu-901 is a humanized anti-immunoglobulin E, or anti-IgE monoclonal antibody that Tanox is developing to prophylactically treat severe peanut allergy. Tanox believes anti-IgE antibodies, such as Hu-901, have potential applications in treating all IgE-mediated diseases, including peanut and other food allergies.

According to a recently published survey, peanut or tree nut allergy affects about 3 million people in the United States, 1.1% of the U. S. population. Patients with severe peanut allergy suffer gastrointestinal, skin and respiratory symptoms, and may also suffer potentially life-threatening anaphylaxis in response to ingesting peanuts. Current treatment is avoiding peanuts and their derivatives, which are used in preparing many food products. Complete avoidance requires constant vigilance and is difficult because prepared food labeling does not always identify peanut-derived ingredients. Accidental exposures can result in serious allergic reactions and sometimes death. Approximately 2 to 4% of children and 1 to 2% of adults in the United States suffer from food allergies. There is no approved preventative therapeutic for food allergies. If Hu-901 is shown to effectively reduce sensitivity to peanuts, Tanox may also investigate its use in other food allergies.

"We are extremely pleased to gain the support of The Peanut Foundation for this important clinical study," said Dr. Nancy Chang, Tanox's Chief Executive Officer. "We plan to use the proceeds from the grant to increase awareness of the study among peanut sensitive individuals and to help defer costs at clinical sites."

"We are very excited about the potential use of Hu-901 to treat patients with severe peanut allergies. The Peanut Foundation is dedicated to improving peanut nutrition and health benefits through research funding and consumer education," said Mr. Howard Valentine, Director of The Peanut Foundation.

Tanox identifies and develops therapeutic monoclonal antibodies to address significant unmet medical needs in the areas of immunology, infectious diseases and cancer. E25, Tanox's most advanced product in development, is an anti-immunoglobulin E, or anti-IgE, antibody. Tanox holds patents around the world covering the use of anti-IgE antibodies for the treatment of IgE- mediated diseases. Tanox is developing E25 in collaboration with Novartis and Genentech. E25 has successfully completed Phase III clinical trials in both allergic asthma and seasonal allergic rhinitis (hay fever). A BLA for E25 has been submitted to the FDA and a submission for marketing approval has been filed with health authorities in the EU, Switzerland, Australia, and New Zealand. In addition, Tanox is developing a number of monoclonal antibodies to treat other allergic diseases or conditions, such as severe allergic reactions to peanuts, autoimmune diseases, HIV and to restore the suppressed immune systems of chemotherapy patients.

Statements in the Company's press releases, reports and information disclosures about its products, including E25 and Hu-901, and their prospects for development and commercialization, other than statements of historical facts, are forward-looking statements and are subject to a number of uncertainties that may cause actual events or results to differ materially from those suggested in the forward-looking statements. Factors that could affect actual events or results include risks associated with obtaining regulatory approval for and market acceptance of the Company's products, performance by the Company's present and future collaboration partners, the outcome of pending litigation, the uncertainty of preclinical and clinical testing results, the Company's limited experience and capability in manufacturing and marketing the Company's products, the Company's ability to enter into future collaborations, competition and technological change, the strength of the Company's patent portfolio, the Company's ability to manage growth and to attract and retain key personnel, the Company's access to additional financings in the future, and existing and future government regulations. Other risks that may affect the Company include the variability of royalty, license and other revenues, timelines that are subject to change, 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.

This release and other information about Tanox, Inc. can be found on the World Wide Web at [url="http://www.tanox.com."]http://www.tanox.com.[/url]

SOURCE Tanox, Inc.

CO: Tanox, Inc.; Peanut Foundation

ST: Texas, Arkansas, California, Colorado, Massachusetts, Minnesota, New York



06/13/2000 07:00 EDT [url="http://www.prnewswire.com"]http://www.prnewswire.com[/url]

On Mar 24, 2002

Chris, can you give us an update on the clinical trials?

On Mar 25, 2002

I can give you a little bit of information. I live in Boston where Children's Hospital is one of the test sites. Every time I go to a lecture given by a Children's Hospital allergist, I ask about the trials. I am told they are going well, although recruitment is slow. Tanox is only testing on people 12 years old and up. That has something to do with ease of FDA approval. Therefore, when the drug does become available to the public, it will only be FDA approved for children 12 and up. However, I am told that there do exist some doctors that will prescribe the drug for a child under 12. Last summer, Tanox suffered a bit of a set back when their asthma drug Xolair was turned away by the FDA. They were counting on putting some of the money from Xolair into the peanut allergy treatment but that never happened. Back to the drawing board for Xolair. Tanox released a statement saying they are still going to continue working on the anit-IGE treatment and that they have enough money to carry them through. Right now they are most concerned with getting participants in the trial to complete their phase I/II trial. I don't know when they will be able to move into the next phase. If anyone has more to add, please feel free to do so.

Dynavax is the company that is working on the cure. I haven't checked into them lately. Last I checked they were in pre-clinical trials. Anyone have any updated info on them?

On May 1, 2002

Tanox, Inc. announced a positive update on Phase II of the peanut trial. Check out [url="http://www.Tanox.com/"]http://www.Tanox.com/[/url] under the "news room" category. Sorry if the link doesn't work!

On May 1, 2002

Thank you so much for that update!!!

On May 1, 2002

That's very encouraging news. Thank you for the update [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

On May 1, 2002

Good news! I wonder when they can move into Phase III?

On May 1, 2002

Double post.

[This message has been edited by Heather2 (edited May 01, 2002).]

On May 6, 2002

I just checked Tanox's website ([url]http://www.tanox.com[/url]) and clicked on the "Product Development" button. It shows how far each drug has gotten in the developmental pipeline (Research, preclinical trials, phases I-III, BLA and Approval). TNX-901 for PA is listed as being halfway through Phase I. Wish I had a better idea of how long each stage takes, and what the estimated date of completion might be. When I pull up info about PA on Yahoo, there are several articles from doctors, hospitals and research companies back in 1999 that practically guaranteed a vaccine or cure would be available by now...*sigh*

On Oct 12, 2003