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 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=<0.05) for the
average of Weeks 4-6 (the primary efficacy analysis specified by the SAP), and
0.0416 (also statistically significant) for the Week 6 analysis. Based on
these strong statistical overall results, the hypothesis testing for the
specific treatment arm comparisons could go forward.
Analysis of the specific comparisons between treatment arms also
demonstrated strong statistical significance. In particular, the comparison
between Placebo (Arm 1) and 6 weeks of Active Treatment (Arm 3) is highly
significant (p<0.010) for both Week 6 and the average of Weeks 4, 5 and 6.
The average symptom score difference seen in this comparison is 1.31 score
units for Week 6, a treatment effect magnitude that reflects clinically
significant benefits for many patients.
Conclusion
Based on the primary modified intent-to-treat analysis, there were
statistically significant differences among treatment arms. The requirements
of the step-down model required by the SAP were met, and statistically
significant treatment benefits were shown between Placebo and Active treatment
groups. A clear statistical separation between Placebo and Active treatment
groups begins as early as Week 3. The largest treatment effect is seen
between Placebo and 6 weeks of Active treatment, with a p-value of 0.0048 at
Week 6, and 0.0028 for the average of Weeks 4, 5 and 6.
In addition, it can be seen that over the 6 week trial, as the allergy
season progressed, patients taking placebo experienced a significantly larger
increase in severity of allergy symptoms compared with the study arms which
included active PreHistin(TM). This difference continues to increase across
the entire 6 week trial. Second it is clear that the study arm wherein
patients received only PreHistin(TM) (no placebo) showed the least increase in
allergy symptoms of all study arms. Most importantly, the average symptom
scores for the combined Weeks 4, 5 and 6 (the primary efficacy endpoint of the
study) demonstrated a statistically significant reduction in allergy symptoms
for patients taking PreHistin(TM) compared with placebo. The data also show
that as people take PreHistin(TM) longer, the beneficial effects increase.
Said Dr. Bradshaw: "The analyses conducted show clear and strong
statistical significance that treatment with PreHistin(TM) demonstrably
reduced patient-reported allergy symptoms versus placebo. All requirements of
the SAP were met and the treatment effect at the primary endpoints is highly
statistically significant."
Lyndon Mansfield, MD, senior medical advisor to the study said: "These
findings open up an entirely different pathway to treat allergic disorders.
The safety factor of PreHistin(TM) added to the therapeutic benefit
demonstrated in this clinical trial makes this treatment a very valuable
option compared to other OTC allergy treatments. This greatly expands our
abilities to treat allergic disease."
Said Chas Radovich, Cobalis CEO: "The Company is very pleased to announce
these dramatic results and to have completed a major milestone towards
bringing PreHistin(TM) to market as the World's First Pre-Histamine(TM). This
unique formulation will bring serious relief to the tens of millions of
allergy sufferers in the US, and provide a safe, less expensive and more
effective approach to controlling allergies than currently available OTC and
prescription allergy medications and antihistamines. We have always known
that PreHistin(TM) is safe, and now we have proven that it's effective. We
look forward to completing the balance of our Phase III program, and
submitting our New Drug Application to the FDA as soon as possible."
About Rhinitis
Allergic rhinitis is one of the most common and chronic diseases in the US,
affecting up to 50 million people each year, including 20 to 30% of adults and
40% of children. Allergic rhinitis can occur both seasonally and year-round.
Seasonal Allergic Rhinitis (SAR) is triggered by seasonally-occurring
allergens, such as pollens from trees, grasses and flowers. Perennial
Allergic Rhinitis (PAR) occurs year-round and is triggered by allergens such
as dust mites, pet dander and various airborne molds.
Nearly half of all allergic rhinitis sufferers (approximately 20% of the
US population) experience symptoms including nasal congestion, runny nose,
nasal itching, and associated symptoms of ocular burning and itching at least
four months of the year. Nearly 70% of allergic rhinitis patients are treated
for nasal congestion -- the most frequently treated symptom.
ABOUT COBALIS CORP. -- PREHISTIN(TM)
Headquartered in Irvine, California, Cobalis Corp. is an over-the-counter,
specialty pharmaceutical company. Its flagship product, PreHistin(TM) 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(TM)," has shown in previous
studies to modulate the body's level of the protein IgE, thereby 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
Certain statements contained in this release are considered "forward-
looking" statements (as defined in the Private Securities Litigation Reform
Act of 1995). Because these statements include risks and uncertainties, actual
results may differ materially from those expressed or implied. These forward-
looking statements are identified by their use of terms and phrases such as
"believe," "expect," "plan," "anticipate," "possibility" and similar
expressions identifying their forward-looking character. Investors should not
rely on these forward-looking statements as assurances of future events,
because such statements are subject to a variety of risks, uncertainties and
other factors that could cause actual results to differ materially from the
Company's expectations. Specifically, factors could include, but are not
limited to: risks associated with preclinical and clinical developments in the
biopharmaceutical industry in general and in the Company's compounds under
development in particular; the potential failure of the Company's compounds
under development to prove safe and effective for treatment and prevention of
disease; failure to successfully implement or complete clinical trials;
failure to receive marketing clearance from regulatory agencies for the
Company's compounds under development; acquisitions, divestitures, mergers,
licenses or strategic initiatives that change the Company's business,
structure or projections; the development of competing products; uncertainties
related to the Company's business, structure or projections; the development
of competing products; uncertainties related to the Company's dependence on
third parties and partners; and those risks described in filings with the SEC.
SOURCE Cobalis Corp.
 back to top
Related links:
http://www.cobalis.com
CONTACT:
Chas Radovich, CEO of Cobalis Corp.,
+1-949-757-0001, Investor.Relations@Cobalis.com; Tim Clemensen,
Senior Vice President of Rubenstein Investor Relations,
TClemensen@RubensteinIR.com, +1-212-843-9337; or Michelle Manoff,
Senior Vice President of Rubenstein Public Relations,
+1-212-843-8051, MManoff@RubensteinPR.com
|
