Cyanocobalamin (the active ingredient in PreHistin™) is currently an approved drug in essentially every country, for a variety of indications. There are a number of early clinical papers and some later reports which showed a benefit of cobalamin therapy in allergic disease, especially seasonal allergic rhinitis (seasonal allergies), and inhibition of IgE synthesis.

Cyanocobalamin has an excellent and well established safety profile.

In 1992 O’Connor, and again in 1996 Mansfield, presented to the US Food and Drug Administration (FDA) on behalf of Cobalis Corp’s predecessor company, Broncorp, Inc., clinical trial data on the use of cyanocobalamin to treat subjects with seasonal allergic rhinitis (Under IND #30,488). Subsequently the FDA indicated that two adequate and well controlled Phase III studies would be needed for marketing approval.

The Company has completed it's Phase III research studies in the United States on approximately 2000 total subjects aimed at approval of PreHistin™.  Further studies are planned using Board Certified Allergists and Immunologists at multiple sites.   Prehistin, USP, is presently marketed as a Cobalamin supplement delivered by means of a sublingual lozenge with the indication of prevention of seasonal and perennial allergic rhinitis.

Medical professionals click here for detailed pharmacologic effects of cobalamin in animal and human models. (Adobe Acrobat Reader required to view document).

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