• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Cobalis Reports All Patient Diaries in Phase III Clinical Trials for OTC Anti-Allergy Product Candidate Are Completed

Posted on: Tuesday, 7 November 2006, 09:00 CST

Cobalis Corp. (OTC BB: CLSC) a pharmaceutical development company specializing in anti-allergy medications, announced today that all of the patient diaries have been completed for its ten-week twin Phase III Clinical Trials for its anti-allergy medication, PreHistin™, thereby concluding all patient participation in the studies. The randomized, double blind, placebo-controlled trials are designed to test the safety and efficacy of pre-seasonal treatment with PreHistin on moderate to moderately severe seasonal ragweed allergy patients.

The Phase III Clinical Trials involved 1,551 patients at 23 sites across the central, southern and eastern United States who received either placebo or a 3.3 mg sublingual dosage of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season and for an additional three weeks into the allergy season. Symptom diaries were maintained for an additional four weeks following treatment to determine duration of effect. Cobalis anticipates reporting top-line efficacy results from the pivotal trials in the first quarter of 2007.

In the US alone, approximately 40 million people suffer from allergic rhinitis. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with allergic rhinitis, or 30 million Americans. Current therapeutic options are mainly limited to symptomatic therapies and conventional allergy immunotherapy.

As previously announced, Cobalis Chief Executive Officer Gerald Yakatan, PhD. will address the investment community this morning at the Rodman & Renshaw 8th Annual Healthcare Conference at approximately 10:35 a.m. ET at the New York Palace Hotel in New York City.

Interested parties can access a live audio webcast of the Cobalis presentation at the Company's website www.cobalis.com. An audio replay of the presentation will be available by the end of the day and will be archived for 90 days.

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 prevention medication in Phase III Clinical development. Cobalis anticipates reporting results of its pivotal twin Phase III trials in Q1 2007. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com

Safe Harbor

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-KSB filed with the SEC on July 14, 2006.

Source: Business Wire

More News in this Category