Helix BioPharma Reports on 2008 Annual General Meeting and Provides Corporate Update
Annual General Meeting Results
All seven Board members were re-elected as directors, with the Board continuing to be constituted of:
KPMG LLP was re-appointed as the Company's auditor.
The shareholders also approved the Company's 2008 new Stock Option Plan. Details regarding the new plan are contained in the Company's Information Circular dated Oct. 28, 2008, filed on SEDAR at www.sedar.com.
Research & Development Update
The Company is continuing its efforts toward milestone investigational new drug application (IND) filings in the United States for L-DOS47 and Topical Interferon Alpha-2b, in its cervical dysplasia indication, by the end of its 2009 fiscal year ending July 31, 2009.
Helix intends to conduct a pre-IND meeting with the FDA to confirm its North American Phase I program plans for L-DOS47. The Company expects the pre-IND meeting to occur in the beginning of the 2009 calendar year. Pending the positive outcome of the pre-IND meeting and timely success of the ongoing and remaining pre-clinical and manufacturing preparatory initiatives, the Phase I IND filing for this program is anticipated to occur sometime before the 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 IND and CTA dossiers, respectively, before the end of the Company's fiscal fourth quarter ending July 31, 2009, pending success with its pharmacokinetic study plans, ongoing GMP manufacturing scale-up program and further proceedings with regulatory authorities.
Helix projects that its parallel confirmatory efficacy trials for Topical Interferon Alpha-2b will require approximately a two-year period to complete, followed thereafter by the preparation and filing of marketing applications. Conducting these trials will require substantial funding beyond the Company's current resources, for which the Company continues to seek additional capital. Assuming that the Company obtains the necessary funding in due course in order to commence these trials in early 2010, then, subject to other risk factors, including without limitation, expedient IND and CTA regulatory approvals and positive results from the ensuing trials, marketing applications could be made as early as 2012.
Ano-Genital Wart Indication
Helix is continuing to progress with its ongoing Phase II trial of Topical Interferon Alpha-2b in patients with ano-genital warts. The trial is underway in Sweden, and was recently expanded to include sites in Germany. Since receiving regulatory approvals to open these German sites, site initiation activities are progressing well with a view to completing patient enrollment by the end of the Company's fiscal fourth quarter ending July 31, 2009.
A copy of the Company's presentation given at its 2008 Annual General Meeting will be made available via the Company's website at www.helixbiopharma.com.
About Helix BioPharma Corp.
Helix BioPharma Corp. is a biopharmaceutical company specializing in the field of cancer therapy. The Company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies. Helix's product development initiatives include its Topical Interferon Alpha-2b and its novel L-DOS47 new drug candidate. Helix is listed on the TSX under the symbol "HBP".
This News Release contains certain forward-looking statements and information regarding Helix's drug development plans, which statements and information can be identified by the use of forward-looking terminology such as "intends", "plans", "expects", "pending", "to occur", "objective", "believes", "on track", "is being designed", "proceeding", "intention", "to seek", "projects", "anticipates", "2009", "2010", "2012", "assuming", "continuing", "with a view to", "if", "developing", or variations thereon, or that events "could" or "would" occur or be achieved, or comparable terminology referring to future events or results. Forward looking statements and information are statements and information about the future, are not historical facts, and are inherently uncertain. Helix's actual results could differ materially from those anticipated in these forward-looking statements and information as a result of numerous risks and uncertainties including without limitation: Helix's need for further financing, which may not be available; uncertainty whether the Company's products under development, including L-DOS47 and Topical Interferon Alpha-2b, will be successfully developed and commercialized as drugs or at all; uncertainty whether clinical trials will proceed as planned or at all, and the risk that clinical trial results may be negative; product liability, insurance and intellectual property risks; research and development risks; the need for further regulatory approvals, which may not be obtained; the Company's dependence on its contract service providers, licensors, optionees and other collaborators for performance; upscaling and manufacturing risks; partnership / strategic alliance risks; the effect of competition; uncertainty of the size and existence of a market opportunity for Helix's products; changes in business strategy or plans; as well as a description of other risks and uncertainties affecting Helix and its business, as contained in news releases and filings with securities regulatory authorities, including its latest Annual Information Form at www.sedar.com, any of which could cause actual results to vary materially from current results or Helix's anticipated future results. Forward-looking statements and information are based on the beliefs, assumptions and expectations of Helix's management at the time they are made, and Helix does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions or expectations, or other circumstances change, except as required by law.
Donald H. Segal Chairman of the Board and Chief Executive Officer Kenneth A. Cawkell Director and Corporate Secretary John Docherty Director and President Thomas Hodgson Director Jack Kay Director Gordon M. Lickrish Director Slawomir Majewski Director
SOURCE Helix BioPharma Corp.
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