PREHISTIN™ PHASE III CLINICAL TRIALS

Cobalis commenced Phase III Clinical Trials for PreHistin™ in November 2004, when the Company engaged its first Phase III study with four arms and 714 patients during the Mountain Cedar allergy season in central Texas. The primary endpoint of the study was reduction in Total Nasal Symptom Score (TNSS).  In July 2006, Cobalis began two twin 10 week pivotal trials with 1551 patients designed to determine the efficacy and safety of 3.3mg of PreHistin BID versus placebo in seasonal ragweed sufferers, with the primary endpoint being the TNSS for weeks 4, 5 and 6. Data from the Mountain Cedar study were used to design the pivotal ragweed studies and are expected to support the results from these pivotal trials in a New Drug Application to the FDA. The Company anticipates announcing the results of the pivotal Phase III ragweed trials by early Spring 2007. If these trials are successful, the Company intends to seek FDA approval to market PreHistin as an over-the-counter allergy medication for seasonal allergic rhinitis.

Phase III trials are conducted to provide data for statistical evaluation of efficacy and safety, with an end result of FDA approval for specific marketing claims and required packaging disclosure and documentation. Government regulation in the US is a significant factor in the production and marketing of new drugs. The FDA must approve all new OTC and prescription  drugs, which includes any new use for a substance, even if previously used safely for a different purpose. In the US, companies are subject to rigorous requirements in order to engage in human clinical testing to, in turn, gain approval of a drug.

The primary indication being studied is the reduction of the symptoms of seasonal allergic rhinitis (outdoor allergies or hay fever).

Based on the FDA's requirement, two sets of well-controlled, multi-site, double-blind, placebo-controlled studies must be conducted. Cobalis enrolled 714 patients in its first Phase III study which commenced in late 2004. The study included three treatment arms and a placebo arm to evaluate the effectiveness and safety of different treatment regimens. Results of this study demonstrated reduced allergy symptoms compared with placebo, and provided the basis for design of our twin pivotal studies intended to meet the FDA’s approval requirements.

In July 2006, the Company commenced two twin Phase III Trials across the eastern and mid-U.S. ragweed allergy regions. These pivotal studies enrolled a total of 1551 ragweed sensitive seasonal allergy patients in central and eastern United States with demonstrated history of moderate to moderately severe allergy to ragweed.  Each study had two arms, consisting of a placebo lozenge BID and 3.3mg cyanocobalamin BID, and a primary endpoint of reduction in TNSS for weeks 4,5, and 6.  Patients received PreHistin or placebo for six weeks, beginning two weeks prior to the expected onset of the ragweed allergy season, and were to maintain symptom diaries for an additional four weeks, for a total of ten weeks. 

 

In November 2006, the Company announced that it had completed its two pivotal trials in seasonal ragweed.  The Company anticipates reporting results from these trials by early Spring 2007.

Cyanocobalamin, the primary active ingredient in PreHistin™, has been extensively studied and has an established safety record.

Clinical Trials and Product Milestone Timetable

Following is Cobalis' domestic planning for completion of Phase III Clinical Trials and initial market introduction of PreHistin™ in the US.

::	First Phase III Clinical Trial completed with 714 patients in
::	Pivotal twin Phase III Clinical Trials commenced July 2006; Completed November 2006
::	Break blind on data and commence statistical analyses of Ragweed study data- Q1 07
::	Submit NDA (New Drug Application) to FDA – Q3 2007
::	FDA Review completed Q2-Q3 2008
::	If approved, US marketing launch 2008

Supplemental Indications Timetable

Cobalis may sponsor clinical research for approval of additional indications.

::	Conduct pediatric clinical trials for seasonal allergic rhinitis for gaining FDA approval of supplementary indication of PreHistin™ for pediatric use
::	Consider conducting clinical trials for gaining FDA approval of supplementary indication of atopic asthma
::	Consider conducting clinical trials for gaining FDA approval of supplementary indication for atopic migraine

Additional Delivery Mechanisms Timetable

Cobalis may also consider sponsoring and conducting studies to develop and gain marketing approval for additional delivery mechanisms.

– Conduct bio-equivalency studies to determine additional delivery mechanisms that can provide similar or greater delivery to the bloodstream as the sublingual lozenges; Mechanisms being considered include quick dissolve tablets, chewing gum, liposomal spray, drops, rice paper, transdermal patch and others.

 

Read PREHISTIN™ INDICATIONS