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Phase 2 Clinical Trial of R112 for Allergic Rhinitis Initiated
The Phase II, randomized, placebo-controlled "Park" study is taking place in two outdoor locations in different parts of the country. The study, which began in mid-April, is being conducted by researchers near Atlanta, Georgia and in San Diego, California. The study will enroll approximately 300 patients (approximately 150 patients per site) that have experienced seasonal allergic rhinitis during the spring pollen season for the previous two years. The study endpoints include nasal symptom scores, time to the onset of the effect and safety measures. Results are expected in the second half of 2004.
"The initiation of this clinical trial represents a significant step in the development of R112 as a first-line allergy therapeutic for the treatment of allergic rhinitis," stated Elliott B. Grossbard, M.D., Senior Vice President of Medical Development. "This trial will evaluate R112's comprehensive approach to treating the major symptoms of allergic rhinitis."
About Allergic Rhinitis
Allergic rhinitis is a common condition that affects nearly 59 million people in the United States -- nearly 20 percent of the population. Allergic rhinitis is characterized by inflammation of the nasal membranes accompanying symptoms that may include sneezing, nasal congestion, nasal itching and rhinorrhea. The eyes, ears, sinuses and throat can also be involved. The U.S. market for allergic rhinitis therapies approaches $4 billion.*
The Role of Immune Mediators in Allergic Rhinitis
Allergic rhinitis involves inflammation of the mucous membranes of the nose, eyes, eustachian tubes, middle ear, sinuses and pharynx. This inflammation is characterized by a complex interaction of inflammatory mediators but ultimately is triggered by an immunoglobulin E (IgE)-mediated response to a foreign allergen. When a specific allergen (e.g., pollen) is inhaled into the nose, it can bind to the IgE on the mast cells, leading to immediate and delayed release of a number of mediators, which can ultimately lead to common allergic symptoms such as nasal congestion, sneezing, itching and rhinorrhea. These mediators include histamine, tryptase, chymase, kinins, heparin, leukotrienes and PGD2. PGD2 is the immune mediator most commonly associated with the chronic symptoms of allergic rhinitis.
How R112 Works and Its Possible Advantages
R112 enters mast cells, binds to an intracellular target and interrupts the signal from the IgE receptor, thus preventing downstream signaling and subsequent chemical mediator release. However, unlike common allergy drugs such as antihistamines or antileukotrienes that block only a single mediator, R112 is designed to block all of the major pathways that are triggered in an allergic attack, potentially making R112 a more effective and comprehensive drug. Currently, steroids are the major class of drugs that are able to block multiple mediators in the allergic response, but these have a slow onset of action, sometimes requiring multiple days of treatment before a positive effect is seen. In the phase I/II trial, R112 began to diminish chemical mediator release within minutes after allergen challenge. R112 is delivered intranasally, and no systemic exposure to R112 has been detected in any intranasal administration in any human trials completed to date.
Source: Rigel Pharmaceuticals, Inc