In the randomized, six week, placebo-controlled trials involving a total of 1,551 subjects, PreHistin did not achieve statistically significant differences from placebo in the primary measure of efficacy, the reduction in total nasal symptom score (TNSS). However, the TNSS data for placebo-treated patients was far lower than would be expected for the moderate to moderately severe patient population called for in the protocol. Low pollen counts in many of the regions during the time PreHistin was being tested may have resulted in low mean placebo symptom scores for the overall study population.
The trials showed that PreHistin was well tolerated and thus contributed positively to the safety record of PreHistin's active ingredient, cyanocobalamin.
A comparison of pre- and post-treatment blood levels of cobalamin demonstrated for the first time in a large study population that delivery of cyanocobalamin via sublingual lozenges resulted in significant increases in cobalamin blood levels.
Cobalis' Chief Scientific Officer Ernest Armstrong commented: "Showing a meaningful reduction in allergy symptoms when the symptoms never increased throughout the pollen season to the desired moderate to moderately severe level is next to impossible. It's like trying to prove that a pump can pump water out of a swimming pool when there is almost no water in the pool to begin with. Other pharmaceu tical companies studying allergy drugs have reported problems with their clinical trials because of low symptom scores in an allergy season, with at least one report in an analogous situation occurring in the 2006 ragweed season when we conducted our trials."
The Company's chief executive officer, Gerald Yakatan, Ph.D., said, "It is unfortunate that nature did not provide the level of allergy symptoms we needed for our studies, but we continue to believe in PreHistin as a product. Cobalis remains committed to a corporate strategy based on bringing PreHistin to the consumer market. Going forward, we will continue pursuing FDA approval of PreHistin as an OTC drug if we assess the prospects for such approval to be favorable, but we will also investigate other potential marketing channels."
Details of the Study
The parallel, randomized, double-blind Phase III clinical trials for PreHistin involved 1,551 patients at 23 sites across the central, southern and eastern U.S. The patients received either a placebo or a 3.3-mg sublingual dosage of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season and for an additional three weeks into the allergy season. The primary efficacy parameter for each trial was the difference in the mean reduction in Total Nasal Symptom Score (TNSS) observed between the placebo and PreHistin over the fourth, fifth and sixth weeks of the studies. TNSS is a 12-point scale derived by summing and averaging all a.m. and p.m. scores for four symptoms: sneezing, runny nose, nasal congestion and nasal itch. Each symptom is given a score - 0 (none), 1 (mild), 2 (moderate) or 3 (severe) - resulting in a maximum recorded daily mean TNSS of 12. Patients maintained electronic diaries twice daily, self-rating their average symptoms over the previous 12 hours.
The Company delayed reporting preliminary top-line analyses from the two Phase III trials due to diary data entry inconsistencies. To evaluate wh ether these inconsistencies were sufficient to represent a systematic error that could affect the outcome of the analyses, the Company engaged an expert external consultant to conduct an audit of the electronic diary database. The study audit found that the electronic diary system functioned correctly and the diary data entered by the patients were correct. The inconsistencies noted earlier were primarily human errors that were corrected and did not alter the study outcomes.
About Seasonal Allergic Rhinitis
Seasonal allergic rhinitis, otherwise known as hay fever, is an allergic reaction to airborne substances such as pollen that get into the upper respiratory passages and cause the body to produce antibodies and release histamine. Histamine makes the upper respiratory membranes swell and produce typical allergy symptoms such as sneezing, runny nose and nasal congestion. In the U.S., approximately 50 million people suffer from seasonal allergic rhinitis, with related healthcare costs exceeding $7 billion annually. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with seasonal allergic rhinitis, or 30 million Americans. Current treatment options are mainly limited to symptomatic therapies to provide temporary relief and conventional allergy immunotherapy by injection.
PreHistin is a sublingual lozenge that delivers its active ingredient through the buccal membrane directly into the bloodstream. The active ingredient, cyanocobalamin, has a well-known safety profile and has been shown in studies to relieve symptoms related to seasonal allergies, asthma and other atopic allergic diseases. PreHistin may represent a novel approach to treatment by rectifying imbalances in the immune system that trigger the over-production of allergy symptom-causing substances including histamines. By preventing or reducing the over-production of these substances before they are released from cells, the need to blo ck the symptom-causing effects of histamine may be eliminated, or minimized. PreHistin is patented for the treatment of atopic allergic diseases such as seasonal and perennial allergies, dermatitis, migraine, food allergies and asthma.
About Cobalis Corp.
Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy medication in Phase III clinical development. For further information, visit www.cobalis.com
Safe Harbor Statement: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cobalis disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to securing funding for ongoing operations including clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future resu lts of clinical trials), the development of competing products by our competitors; uncertainties related to the Company's dependence on third parties and partners; and those risks described in our SEC filings and annual report on Form 10-KSB filed with the SEC on July 14, 2006.
Investor Relations International
Haris Tajyar, 818-382-9702