Cobalis Completes Enrollment in Twin Phase III Clinical Trials for PreHistin(R).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 successfully completed the enrollment of a total of 1,551 patients across two identical Phase III Clinical Trials of its anti-allergy medication PreHistin(R) in patients with moderate to moderately severe seasonal allergic rhinitis seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis. . The trials are being conducted at 23 sites across the central, southern and eastern United States. It is expected that the ten-week trials will be completed in November. Cobalis expects to report final data from these Phase III Clinical Trials in the first quarter of 2007, followed by submission of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to the U.S. Food and Drug Administration (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. ). Dr. Gerald Yakatan, 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. , said, "I am very pleased with the speed and efficiency with which the patient enrollment was conducted, and I believe it is a reflection of the breadth of the market Breadth of the market In the context of general equities, percentage of stocks participating in a particular market move. Technical analysts say there was significant breadth if two-thirds of the stocks listed on an exchange move in the same direction during a trading session. opportunity we are addressing. I would like to congratulate our clinical team on a job well done. Assuming a favorable trial outcome, we plan to expeditiously prepare and submit the NDA." These twin studies, consisting of 788 and 763 patients, are anticipated to fulfill the requirement for the two Phase III double blind, placebo controlled studies typically required for FDA approval. 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 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 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 reports on Form 10KSB and 10QSB filed with the SEC on July 14, 2006 and August 18, 2006, respectively. |
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