Friday, May 14, 1999
Oslo -- May 14, 1999 --A new investigational compound may help control allergy symptoms and reduce the need for rescue allergy medications, according to a study presented today at the 20th Annual Nordic Congress on Allergology. Results from the Phase III clinical trial showed that treatment with anti-IgE (rhuMAb-E25), a recombinant humanized monoclonal antibody to IgE, decreased the severity of nasal and ocular allergy symptoms compared to placebo, and reduced the number of rescue allergy medication tablets by more than 50 percent.
The randomized, placebo-controlled, multicenter clinical trial examined symptoms of rhinoconjunctivitis and rescue medication usage in 251 adult patients in Scandinavia with a history of birch pollen allergy. Patients were treated with either 300mg anti-IgE or placebo via subcutaneous (under the skin) injection - two injections given three or four weeks apart - during the 1998 birch tree pollen season in Scandinavia. Rescue medications, such as antihistamines, were used when patients determined that their symptoms were severe enough to require additional medication.
Using a scale of 0 for no symptoms and 3 for severe symptoms, anti-IgE, when compared to placebo, led to a decrease in patient nasal and ocular symptoms of 0.23 and 0.09, respectively. Results showed that patients receiving anti-IgE used on average 0.5 antihistamine tablets per day versus 1.3 tablets per day in the placebo group, and used allergy medication on less than half as many days.
"Genentech and Novartis are pleased with the positive results of this Phase III trial, which suggest that anti-IgE could be an important therapy for allergic diseases," said Dr. Joerg Reinhardt, Global Head of Development at Novartis Pharma AG. "We look forward to moving ahead with the development of this novel compound."
"The results of this study demonstrate the therapeutic potential anti-IgE holds as a treatment for seasonal allergic rhinitis," said Dr. Thomas Sandstrom, Professor of Respiratory Medicine and Allergy at University Hospital, Ume, Sweden and lead investigator of the clinical trial. "The compound's performance with birch pollen allergies suggests its potential as a treatment for reactions to other allergens, which will require further investigation." Other Phase III trials being conducted in allergic asthma are expected to be completed by the end of 1999.
Anti-IgE treatment was well tolerated during this Scandinavian trial. No antibodies against anti-IgE were detected and no serum sickness, immune complex disease, anaphylactic reactions, systemic urticaria (itching and hives) or other allergy-related side effects were reported. The most common side effects occurring in less than two percent of patients were headache (1.8 percent) and upper respiratory infection (1.2 percent). The incidence of adverse events was similar for the anti-IgE and placebo groups. In previous clinical trials, approximately three percent of patients receiving anti-IgE experienced drug-related systemic urticaria.
IgE is an antibody that triggers the release of inflammatory mediators, such as histamine, prostaglandins and leukotrienes, thereby causing the symptoms associated with allergic reactions. The release of these inflammatory substances plays a major role in allergic disease, such as allergic asthma and seasonal allergic rhinitis.
Anti-IgE works by binding to circulating IgE in the blood. The treatment is intended to intervene early in the allergic process by targeting the source of allergy inflammation for all allergens, IgE. Anti-IgE prevents IgE from binding to mast cells, thereby blocking the consequent release of inflammatory mediators.
Genentech, Inc. and Novartis Pharma AG are collaborating on Phase III clinical development of anti-IgE. The safety and efficacy of this Phase III clinical investigation will be determined by the U.S. Food and Drug Administration as well as other regulatory authorities as part of the market registration process.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Twelve of the currently marketed biotechnology products stem from Genentech science, seven of which Genentech markets directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
Novartis is a world leader in Life Sciences, with core businesses in Healthcare, Agribusiness and Consumer Health (Nutrition and Self-Medication). In 1998, Novartis Group sales were $21.8 billion, of which $12 billion were in Healthcare, $5.8 billion in Agribusiness and $4 billion in Consumer Health. The group annually invests more than $2.6 billion in research and development. Headquartered in Basel, Switzerland, Novartis employs a workforce of about 82,000, and operates in over 100 countries around the world. The company's US headquarters are located in Summit, NJ.
Tanox, Inc. collaborated in the research and discovery of anti-IgE compounds. Incorporated in 1986, Tanox is a biotechnology research and development company based 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.
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