Cobalis Corp. to Start 6-Week Clinical Trial Study with 624 Patients on November 29, 2004 as Part of Ongoing Phase III Trials 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. : CLSC CLSC Centre Local de Services Communautaires CLSC Chautauqua Literary and Scientific Circle CLSC Cisco LAN Switch Configuration CLSC Carter Lake Sailing Club (Larimer Country, CO, USA) CLSC Contractor Logistic Support Commitment ), a pharmaceutical company specializing in the development of anti-allergy medications, announced today that on November 29, 2004 it will start a 6-week clinical trial study with 624 patients, as a part of the ongoing Phase III Clinical Trials for their flagship anti-allergy product PreHistin(TM). Cobalis Corp. has selected 8 clinical investigation sites which are currently enrolling a minimum of 624 patients, ages 17 to 75, with a demonstrated multi-year history of sensitivity to Mountain Cedar pollen for this study. Under the guidance of Dr. Lyndon Mansfield, Cobalis Corp's Senior Medical Advisor, the clinical investigators, 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/or Immunology, will conduct a 6-week study of the ability of PreHistin to mitigate the onset of the symptoms of seasonal allergies as compared to placebo. The study, entitled: A PHASE 3, 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 OF THE SAFETY AND EFFICACY OF PRE-SEASONAL SUBLINGUAL sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue. sub·lin·gual adj. Abbr. SL Below or beneath the tongue; hypoglossal. CYANOCOBALAMIN cyanocobalamin: see coenzyme; vitamin. LOZENGES ON 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. IN HUMANS has recently received approval from Institutional Review Board IntegReview, as announced by the Company yesterday. The study will comprise multiple study arms to generate data to validate the optimal pre-seasonal treatment duration of PreHistin, which is intended to be taken for two to three weeks prior to the onset of allergy season. Following completion of its Phase III Clinical Trials the Company will seek US 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. 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. : "We are excited to hit our planned milestone for our Phase III Clinical Trials of PreHistin with so many well-respected investigators. We extend our thanks to every member of the professional team that has worked so hard to keep this complex program on track, and to the US FDA for their extensive and open communications with us towards refining our Phase III study protocols. 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 US prevent the onset of their allergy symptoms." Dr. Lyndon Mansfield, Senior Medical Advisory for Cobalis commented: "The Company has selected a highly experienced and credentialed team of clinical investigators who are all recognized experts in this field, and we anticipate a smooth completion of our Phase III Clinical Trials." 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 scheduled for Phase III clinical trials in late 2004 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 clinical 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 website at http://www.cobalis.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 Corp's 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 Corp's compounds under development in particular; the potential failure of Cobalis Corp's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Cobalis Corp's compounds under development, failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Cobalis Corp's business, structure or projections; the development of competing products; uncertainties related to Cobalis Corp's business, structure or projections; the development of competing products; uncertainties related to Cobalis Corp's dependence on third parties and partners; and those risks described in the filings with the SEC, all of which are under the Company's prior name BioGentech Corporation. Cobalis Corp. disclaims any obligation to update these forward-looking statements. |
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