Cobalis Completes Patient Dosing in Phase III Clinical Trials for OTC Anti-Allergy Product Candidate.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 the Company has completed the dosing portion of its ten-week twin Phase III Clinical Trials for its anti-allergy medication, PreHistin[TM]. 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 are being 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. "We are pleased to reach this milestone in our Phase III development program for PreHistin" commented Chief Scientific Officer, Ernie Armstrong. "The market for allergy prevention and treatment is ripe for new entries and we are hopeful that, if successful, our direct to OTC strategy will soon provide ready access to relief for millions of seasonal allergy suffers." The objective of the twin Phase III pivotal trials is to provide the 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. with sufficient safety and efficacy data to support marketing approval of PreHistin. The primary efficacy parameter for each trial is the difference in the mean reduction in Total Nasal Symptom Score (TNSS TNSS total nasal symptom score ) observed between placebo and PreHistin over weeks four, five and six of the studies. 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 Migraine Headache Definition Migraine is a type of headache marked by severe head pain lasting several hours or more. Description Migraine is an intense and often debilitating type of headache. , atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy prevention medication. 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 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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