Cobalis Corp. Phase III Trial for PreHistin(TM) Shows Positive Results for Pre-Seasonal Treatment to Mitigate Allergy Symptoms i
July 20 2005 - 9:33AM
PR Newswire (US)
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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