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Helix BioPharma Reports on 2008 Annual General Meeting and Provides Corporate Update
Date:12/16/2008

end of Helix's fiscal fourth quarter, ending July 31, 2009. In addition, Helix is considering conducting a parallel confirmatory Phase I program in Europe, and is actively investigating the necessary regulatory filing requirements to facilitate this in this same time period.

Helix's objective for the commercialization of L-DOS47 is to enter into a strategic alliance with a large pharmaceutical company at some point in the future. Before doing so, Helix plans to endeavor to generate value-adding clinical findings demonstrating the safety and efficacy of L-DOS47 in patients. Helix believes that there is a substantial market opportunity for L-DOS47 given that (i) its target therapeutic indication, lung adenocarcinoma, represents a significant and unmet medical need afflicting some 40 to 50 percent of the estimated 1.5 million new lung cancer patients annually worldwide and (ii) therapeutics for such oncology applications have commonly been high revenue generators for the pharmaceutical sector.

Topical Interferon Alpha-2b

Cervical Dysplasia Indication

Helix is progressing on track for filing a clinical trial application (CTA) in Europe for a pharmacokinetic study in patients with cervical dysplasia. This study is being designed, as mandated by regulatory authorities, in order to gather further evidence of the product's absorption and elimination profile prior to proceeding with clinical testing of the product on a mass scale. It is Helix's intention to use interim findings, if possible, from this study in order to provide support for its anticipated regulatory filings to seek approval to conduct two parallel confirmatory pivotal efficacy trials for this therapeutic indication. As previously described, the Company expects the confirmatory trials to consist of a Phase IIb trial in the U.S. and a Phase III trial in Europe. Helix expects to file the necessary IN
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SOURCE Helix BioPharma Corp.
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