Cobalis Corp. Phase III Trial for PreHistin(TM) Shows Positive Results for Pre-Seasonal Treatment to Mitigate Allergy Symptoms i

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Cobalis Corp. Phase III Trial for PreHistin(TM) Shows Positive Results for Pre-Seasonal Treatment to Mitigate Allergy Symptoms in Humans IRVINE, Calif., July 20 /PRNewswire-FirstCall/ -- Cobalis Corp. (OTC:CLSC) (BULLETIN BOARD: CLSC) , a pharmaceutical biotech company specializing in the development of anti-allergy medications, announced today that preliminary analyses performed on data collected during their first Phase III Clinical Trial for their flagship anti-allergy medication PreHistin(TM) has demonstrated that pre-seasonal treatment with PreHistin(TM) was seen to clearly reduce allergy symptoms. The Study The study, entitled A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP STUDY OF THE SAFETY AND EFFICACY OF PRE-SEASONAL SUBLINGUAL CYANOCOBALAMIN LOZENGES ON MILD TO MODERATELY SEVERE ALLERGIC RHINITIS IN HUMANS was conducted by 8 Board Certified Allergists and Immunologists during the most recent Mountain Cedar pollen season. A total of 715 patients, aged 17 to 75, with a demonstrated multi-year history of sensitivity to Mountain Cedar pollen were randomized into 4 study arms, and 641 patients completed the study. Patients received either placebo or active study drug during a 6 week trial; 3 weeks were administered prior to the onset of the allergy season, and patients were studied for an additional 3 weeks following the onset of the allergy season. Patients in two of the study arms received the active medication prior to the onset of the allergy season, and patients in the other two arms received only placebo during this period. The study was intended to generate data to validate that pre-seasonal treatment with PreHistin(TM), will mitigate the onset of the symptoms of seasonal allergies as compared to placebo. Preliminary analyses of the data were conducted by Mark H. Bradshaw, PhD, of GCP_MP, of Princeton, NJ, acting as an independent biostatistician on behalf of the study sponsor Cobalis Corp. The Analyses A preliminary set of analyses was performed using patient-reported twice-daily symptom scores. Detailed analyses of the clinical investigators' patient examinations and of patient blood draws will be conducted in the next few weeks when a final results report will be issued. All analyses conducted by Dr. Bradshaw were based on reflective scores (patients' assessments of their symptomatology over the previous 12 hours). AM and PM self-rated symptom scores each day for each patient were summed across the four primary symptoms: sneezing, runny nose, nasal congestion, and nasal itch. Individual symptom score values were defined as follows: 0=none, 1=mild, 2=moderate, 3=severe. For each symptom, AM or PM, possible scores ranged from 0-3; therefore the maximum possible summed patient symptom score for any particular day was 24 (4 symptoms * 2 collection times * maximum score of 3=24). For each patient, the daily sum of reflective scores was then averaged across all days within a week to arrive at one per-patient average daily reflective symptom score for that week. This single per-patient number was entered into the statistical analysis for each patient; hence for analysis of variance (ANOVA) purposes, N=the number of patients in a particular analysis. The Results Following the SAP (Statistical Analysis Plan) for the study protocol, comparisons between the various study arms, between specific weeks of the study, between patients receiving pre-seasonal treatment versus patients who received placebo pre-seasonally showed definite reductions in Mean AM and PM Scores for the Sum of Four Primary Reflective Symptoms. In addition, symptom scores for sneezing and nasal itch showed that the single study arm that received active PreHistin(TM) throughout the entire 6 weeks had the greatest reduction in symptoms, and performed the best compared with all other study arms. By Week 6 of the study (the last week symptoms were recorded) Arm 3 (the arm in which patients received PreHistin(TM) throughout the entire 6 weeks) showed the lowest overall average symptom scores. Said Dr. Bradshaw: "Based on the analyses that take into account differences in symptom severity at Week 1, it appears there are statistically reliable differences among treatment arms. From a scientific standpoint the evidence for differences among the treatment arms is very strong." Said Chas Radovich, Cobalis CEO: "We are extremely pleased to announce these preliminary results of our first Phase III Clinical Study of PreHistin(TM), and especially pleased that the study arm of patients receiving only PreHistin(TM) fared best in achieving the lowest average symptom scores of all other arms. We had hoped this study and analysis would generate the data we needed to effectively plan our second Phase III Trial for PreHistin(TM), and we have achieved that goal. We look forward to announcing the complete detailed results of this first study shortly, and to moving forward aggressively now to complete our Phase III Clinical Trials program, and gain FDA approval to market PreHistin(TM) as an effective OTC pre-seasonal medication for the mitigation of seasonal and perennial allergy symptoms." Now that the preliminary analyses have been examined, the Company will proceed to have its independent statistical analysts and biostatisticians complete the full detailed analysis of all data points. Cobalis expects to announce the final detailed results within the coming 4-6 weeks. ABOUT COBALIS CORP. -- PREHISTIN (TM) Headquartered in Irvine, California, Cobalis Corp. is an over-the-counter pharmaceutical company. Its flagship product, PreHistin(TM), 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(TM), "the world's first pre-histamine," has shown in previous studies to modulate the body's level of the protein IgE, reducing the overproduction of histamines, the primary cause of airborne allergy symptoms. Prior studies have shown that the active ingredient in PreHistin(TM) appears to have essentially no risks of adverse effects to the general population, including sedation and drowsiness 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 Statement: To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the ability of the Company to raise capital to finance the development of its Internet services and related software, the effectiveness, profitability and the marketability of those services, the ability of the Company to protect its proprietary information and to retain and expand its user base, the establishment of an efficient corporate operating structure as the Company grows and, other risks detailed from time-to-time in our filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statements. DATASOURCE: Cobalis Corp. CONTACT: Charles Radovich, CEO of Cobalis Corp., +1-949-757-0001, ; or Tim Clemensen for Cobalis Corp., +1-212-843-9337

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CLSC Cabana Target Leading Sector Conservative ETF