Cobalis Corp. PreHistin(TM) Significantly Reduces Allergy Symptoms in 714 Patient Phase 3 Clinical Trial
October 27 2005 - 9:30AM
PR Newswire (US)
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=