Safe, Non-Drowsy PreHistin(TM) Achieves Clinical and Statistical Significance (p= 0.0028) Versus Placebo; Study Demonstrates Dramatic Reduction in Allergy Symptoms IRVINE, Calif., Oct. 27 /PRNewswire-FirstCall/ -- Cobalis Corp. (OTC:CLSC) (BULLETIN BOARD: CLSC) , announced today the final statistical analyses on allergy patient symptom scores collected during the first of two required FDA- approved Phase III Clinical Trials for the Company's anti-allergy medication, PreHistin(TM). The study was the largest of its kind, according to Lyndon Mansfield, MD, Cobalis' senior medical advisor, and successfully concludes one of the most important milestones towards gaining FDA approval to market PreHistin(TM) in the US as an OTC medication for pre-seasonal treatment of allergy symptoms. The study demonstrated strong clinical and statistical significance that PreHistin(TM), when administered before and during allergy season, clearly and noticeably resulted in fewer allergy symptoms when compared with placebo. The results pave the way for an entirely new class of 100% non-sedating, anti- allergy medication with no common side effects. PreHistin(TM) is a sublingual lozenge which will offer consumers a safer, more effective and less expensive alternative to existing OTC antihistamines and prescription allergy medications, according to the Company. Cobalis is now planning the second FDA-required large-scale Phase 3 study. According to Cobalis, the strength of the results of this first study fosters a high degree of confidence that equally strong positive results should be seen in the second FDA-required study. The Company believes that the strong clinical results on efficacy, combined with a 50+ year history of safe use of cyanocobalamin (the active ingredient in the patented PreHistin(TM) formula), in treating millions of human patients with hematologic and neurologic illnesses should greatly facilitate the approval process by the FDA and foreign regulators. In written correspondence with Cobalis the FDA has said that "there are no safety concerns with the systemic exposure to cyanocobalamin." The Study Cobalis sponsored a double-blind, placebo-controlled, multi-center randomized study on 714 allergy sufferers to test whether PreHistin(TM) would reduce the onset and severity of allergy symptoms; including sneezing, runny nose, nasal itch and nasal congestion. The study was conducted by Board Certified Allergists and Immunologists at 8 clinical sites in the US. A total of 714 patients, aged 17 to 75, with a demonstrated multi-year history of sensitivity to Mountain Cedar pollen were randomized into 4 study arms; 3 active and 1 placebo during the 6 week trial. No serious adverse events or serious side effects were reported for any of the 714 study subjects. The Analyses Comprehensive analyses of the final study data were conducted by Mark H. Bradshaw, PhD, of GCP MP, of Princeton, NJ, acting as an independent biostatistician on behalf of Cobalis Corp. All analyses conducted by Dr. Bradshaw were based on patient-reported twice-daily 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 itch and nasal congestion. The report issued by Dr. Bradshaw used the modified intent-to-treat population (all patients who took any study medication), and used an ANOVA (standard analysis of variance) model to determine statistical significance of effects among the 4 study arms. The FDA-approved Statistical Analysis Plan (SAP) specified a step-down procedure for evaluating the statistical significance of results. First, it was required to show that the p-value (the overall indicator of reliable differences among groups) across the four treatment groups reached statistical significance at a p-value of less than 0.05 -- the benchmark for demonstrating statistical differences among the treatment groups. Once that criterion was met, only then would comparisons be performed between specific pairs of treatment arms. The Results Statistical analysis using an ANOVA model with adjustment for baseline symptom severity showed that the first criterion of the step-down procedure was clearly met. The p-value for treatment effect overall was 0.0262 (statistically significant at or below the benchmark of p=