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Cobalis Successfully Completes Enrollment of 713 Patients and Starts 6-Week Clinical Study as Part of Ongoing Phase III Trial For PreHistin.


IRVINE, Calif. -- Cobalis Corp. (OTC Bulletin Board OTC Bulletin Board

An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system.
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), a pharmaceutical company specializing in the development of anti-allergy medications, announced today that it has successfully completed enrollment of 713 patients at 8 clinical investigation sites and has officially started a 6-week Phase III Clinical Study for its flagship anti-allergy product, PreHistin(TM). To ensure statistical validation, the study required the enrollment of a minimum of 624 patients.

Under the guidance of Dr. Lyndon Mansfield, Cobalis Corp's Senior Medical Advisor, the clinical investigators, who are all Board Certified board certified,
adj the status of a dental specialist such as an orthodontist who has become a board diplomate by successfully completing the certification program of the recognized certification board in that area of practice.
 or Fellows in Allergy and Immunology, are conducting a 6-week study of the ability of PreHistin to mitigate the onset of the symptoms of seasonal allergies. The study is a Phase III, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind, placebo-controlled, parallel group study evaluating patients with moderate to moderately severe allergic rhinitis Allergic Rhinitis Definition

Allergic rhinitis, more commonly referred to as hay fever, is an inflammation of the nasal passages caused by allergic reaction to airborne substances.
 (Hay Fever hay fever, seasonal allergy causing inflammation of the mucous membranes of the nose and eyes. It is characterized by itching about the eyes and nose, sneezing, a profuse watery nasal discharge, and tearing of the eyes. ).

Following completion of its Phase III Clinical Trials Cobalis will seek U.S. FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval to market PreHistin as an Over-The-Counter (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
) medication for pre-seasonal use to mitigate the onset of symptoms of seasonal allergies.

"We have achieved one of the most important milestones in our Phase III Clinical Trials of PreHistin. We look forward to completing our entire Phase III program, and to the opportunity to bring PreHistin to market as quickly as possible to help the more than 50 million estimated allergy sufferers in the U.S. prevent the onset of their allergy symptoms," said Chas Radovich, Cobalis CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. .

ABOUT COBALIS CORP. -- PREHISTIN(TM)

Headquartered in Irvine, California, Cobalis Corp. is an over-the-counter pharmaceutical company. Its flagship product, PreHistin, designed to prevent the primary cause of airborne allergies, is currently in Phase III clinical trials and initial marketing in the U.S. will commence upon final FDA marketing approval. The U.S. anti-allergy medication market was $7.2 billion in 2003 and is expected to exceed $10 billion by 2010. PreHistin, "the world's first pre-histamine," has shown in previous studies to modulate the body's level of the protein IgE, reducing the overproduction o·ver·pro·duce  
tr.v. o·ver·pro·duced, o·ver·pro·duc·ing, o·ver·pro·duc·es
To produce in excess of need or demand.



o
 of histamines, the primary cause of airborne allergy symptoms. Prior studies have shown that the active ingredient in PreHistin appears to have essentially no risks of adverse effects to the general population, including sedation and drowsiness drows·i·ness
n.
A state of impaired awareness associated with a desire or inclination to sleep. Also called hypnesthesia.


drowsiness Medtalk Semiconsciousness; grogginess, sleepiness
 found in many of the allergy products currently available.

For further information please visit the Web site at http://www.cobalis.com.

SAFE HARBOR

Certain statements contained in this news release are considered "forward-looking" statements (as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements reflect Cobalis' current views about future events. They are identified by their use of terms and phrases such as "believe," "expect," "plan," "anticipate," "possibility" and similar expressions identifying their forward-looking character. Investors should not rely on these forward-looking statements as assurances of future events, because such statements are inherently subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from the Company's expectations. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Cobalis' compounds under development in particular; the potential failure of Cobalis' compounds under development to prove safe and effective for treatment and prevention of disease; uncertainties inherent in the early stage of Cobalis' compounds under development, failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for Cobalis' compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Cobalis' business, structure or projections; the development of competing products; uncertainties related to Cobalis' business, structure or projections; the development of competing products; uncertainties related to Cobalis' dependence on third parties and partners; and those risks described in the filings with the SEC, either under the Company's current name, Cobalis Corp., or its prior name, BioGentech Corp. Cobalis Corp. disclaims any obligation to update these forward-looking statements.
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Publication:Business Wire
Date:Dec 9, 2004
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