Cobalis has conducted two, parallel Phase III Clinical Trials as approved by the US FDA to demonstrate the efficacy of PreHistin™ for the prevention of seasonal and perennial allergic rhinitis (Click Here for Additional Information on PreHistin™ Phase III Research).

Both trials were double-blind, placebo controlled, multi-center, randomized, and conducted by Board Certified Allergists and Immunologists. The initial study, in 2005, was conducted on 714 patients with a demonstrated multi-year history of sensitivity to Mountain Cedar pollen. This study clearly revealed a clinically significant difference between placebo and PreHistin treated groups, such that the PreHistin treated group had much lower severity of allergy scores including sneezing, runny nose, nasal itch and nasal congestion. The second study, conducted in 2006, failed to reveal a statistically significant difference between placebo and PreHistin treated groups, which we believe was due to low allergy symptom scores across both groups of patients due to a low pollen count at the time of the study. This study, however, did reveal a 1) marked blunting of the rise in IgE levels in allergic individuals in the PreHistin treated group compared to the placebo group and 2) a significant average increase of more than 250% in post-treatment blood serum cobalamin (Vitamin B12) levels across two PreHistin treated patient groups, compared with essentially no B12 level increase in placebo-treated patients.

We plan to conduct further studies and believe that successful outcomes of these trials will enable PreHistin™ to be approved by the Food and Drug Administration as an over-the-counter medication in the United States. Presently, PreHistin is marketed and available as a Dietary (Cobalamin) Supplement.

Additional Indications for PreHistin

Prior research on cobalamin strongly suggests that PreHistin™ will also have a significant effect for prevention or reduction of allergic symptoms for perennial rhinitis, and a wide range of other pediatric and adult outdoor, household, food and pet allergies as well. These include, for example, allergies to flower and tree pollen, dust, mold, mites, peanuts, shellfish and pet dander.

Cobalis intends to seek approval from the US FDA to commence Clinical Trials for such additional indications over the coming two years.

Specifically, Cobalis plans to develop appropriate formulations of PreHistin™ for the prevention and treatment of:

Year-Round Allergies

Perennial (continuous) allergic rhinitis, also known as indoor allergies, caused by pet dander, dust mites, cockroaches and indoor mold spores.

Skin Allergies

Skin allergies, including eczema, or atopic dermatitis, which is marked by itchy rashes and oozing blisters; hives or urticaria involving swelling, redness and itching; and contact dermatitis which produces rashes and itching after touching poison ivy or certain foods.

Food Allergies

Adverse allergic reactions to foods, including cow's milk, eggs, peanuts, wheat, and soy.

Asthma

More than 17 million people in the United States, including close to five million children, have asthma. Asthma is a chronic disease in which airflow in and out of the lungs may be blocked by muscle squeezing, swelling and excess mucus.

International Indications

In addition, Cobalis Corp. intends to seek approval from the appropriate regulatory agencies in other countries to market PreHistin™ and related formulas for the prevention, reduction and management of allergic disease on a worldwide basis.

Additional Delivery Mechanisms For PreHistin™

PreHistin sales and marketing was successfully launched by Cobalis on 4/30/09 as a convenient, pleasant-tasting sub-lingual lozenge. Cobalis intends to conduct bio-equivalency studies to develop additional patient-friendly delivery mechanisms that can provide similar or greater delivery to the bloodstream as do the sublingual lozenges.

We intend to research and develop a variety of delivery mechanisms to offer patients their choice of preferred method, including quick dissolve tablets, chewing gum, liposomal spray, liquid drops, rice paper, transdermal patch and others.

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