Cobalis Reports All Patient Diaries in Phase III Clinical Trials for OTC Anti-Allergy Product Candidate Are Completed.IRVINE, Calif. -- Cobalis Corp. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: 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 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[TM], thereby concluding all patient participation in the studies. The 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 trials are designed to test the safety and efficacy of pre-seasonal treatment with PreHistin on moderate to moderately severe seasonal ragweed ragweed, any plant of the genus Ambrosia, coarse, weedy herbs belonging to the family Asteraceae (aster family), most of which are native to America. They have inconspicuous greenish flowers and soft subdivided leaves. 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 sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue. sub·lin·gual adj. Abbr. SL Below or beneath the tongue; hypoglossal. 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 allergen /al·ler·gen/ (al´er-jen) an antigenic substance capable of producing immediate hypersensitivity (allergy).allergen´ic pollen 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
New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. . 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 atopic /atop·ic/ (a-top´ik) (ah-top´ik) 1. ectopic. 2. pertaining to atopy; allergic. atopic 1. displaced; ectopic. 2. pertaining to atopy. disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin[TM] 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 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 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 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 (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. |
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