Healthcare Industry News: migraine
News Release - March 29, 2007
Cobalis Locks Database for Pivotal Twin Phase III Trials of PreHistin(TM) in Seasonal Allergic RhinitisIRVINE, Calif.--(HSMN NewsFeed)--Cobalis Corp. (OTC BB: CLSC ), a pharmaceutical development company specializing in anti-allergy medications, today announced that it has completed the locking of the database for its pivotal twin Phase III Clinical Trials of PreHistin(TM) in seasonal allergic rhinitis. An independent contract research organization (CRO) will now begin the process of implementing the statistical analysis plan designed to analyze the data from the pivotal trials.
"We are pleased to have reached this milestone in our PreHistin trials and look forward to reporting top-line results over the next month," commented Dr. Gerald J. Yakatan, Chief Executive Officer for Cobalis Corp. "These twin trials represent two of the largest clinical trials conducted utilizing this novel anti-allergy approach. Our goal is to be able to offer a new, over-the-counter anti-allergy treatment option for allergy sufferers that goes beyond currently available remedies."
The 1,551-patient pivotal Phase III trials investigated the efficacy and safety of treatment with Cobalis' PreHistin on moderate to moderately severe seasonal ragweed allergy patients. The twin trials were designed to support regulatory approval in the United States and key global markets. The studies' primary endpoint is the average improvement in total nasal symptom score (TNSS) in weeks four, five and six of treatment. To observe duration of effect after treatment, patients maintained diaries for symptomology over the final four weeks of the ten-week study.
About Seasonal Allergic Rhinitis
Seasonal allergic rhinitis is a condition that causes allergy symptoms such as sneezing, runny nose, and nasal congestion. It is believed that people with allergies produce too much IgE (immunoglobulin E). Elevated levels of IgE trigger a release of histamine, which causes common allergy symptoms. Lowering IgE levels helps to prevent the creation and release of histamine. We believe that past research has demonstrated that cyanocobalamin, the active ingredient in PreHistin, reduces IgE. It is estimated that in the United States alone, seasonal allergic rhinitis affects approximately 36 million people, with related healthcare costs exceeding $7 billion annually. Currently available OTC remedies relieve symptoms on a temporary basis and treat symptoms only after they appear, while also often creating significant adverse side effects including drowsiness and sedation. PreHistin is designed to be a non-drowsy, non-sedating pre-seasonal allergy treatment targeted for OTC distribution.
About Cobalis Corp.
Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy medication in Phase III clinical development. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cobalis disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to securing funding for ongoing operations including clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the development of competing products by our competitors; uncertainties related to the Company's dependence on third parties and partners; and those risks described in our quarterly report on Form 10-QSB filed with the SEC on February 20, 2007.
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