AURORA, ON, Dec. 19 /CNW/ - Helix BioPharma Corp. (Helix; TSX, FSE: "HBP") today announced that it has signed an agreement with Edmonton, Alberta-based QSV Biologics (QSV) to develop the cGMP manufacturing process for L-DOS47. "The signing of this agreement with QSV is a major step in the L-DOS47 program," said Dr. Donald Segal, President and CEO of Helix. "We believe QSV's high calibre personnel and facilities for biopharmaceutical manufacturing will accelerate the cGMP production of L-DOS47 for our upcoming preclinical and human clinical studies." "Helix is one of a select few biotech firms whose experienced management team have successfully taken products to market," said Dr. Graeme Macaloney, QSV President & CEO. "The combination of a top class management team and the potential of L-DOS47 is expected to make Helix an excellent client and partner for QSV." About L-DOS47 L-DOS47 combines Helix's proprietary DOS47 new drug candidate with a highly specific antibody, to form a potential new targeted drug product for the treatment of adenocarcinoma of the lung, the most common form of cancer in the world today. L-DOS47 is thought to function by leveraging a natural process in the body called the urea cycle, to produce an anti-cancer effect. It is based upon a naturally occurring enzyme called urease that essentially reverses the urea cycle by breaking down urea into metabolites that include ammonia and hydroxyl ions. By doing so at the site of cancerous tissues in the body, L-DOS47 is believed to modify the microenvironmental conditions of lung cancer cells in a manner that leads to their death. Among these theorized effects, L-DOS47 is believed to stimulate an increase in the pH of the microenvironment surrounding the cancerous cells, effectively reversing the acidic extra-cellular conditions that are known to be necessary for cancer cell survival. As well, the local production of ammonia at the site of cancerous tissues is thought to readily diffuse into the cancer cells to exert a potent cytotoxic effect by interfering with their critical metabolic functions. About QSV Biologics Ltd. QSV is a privately held contract manufacturing organization (CMO), highly specialized in the cGMP manufacturing of biopharmaceuticals. As a dedicated contract manufacturer, QSV offers cell bank development, process & analytical development, technology transfer, scale up and pre-clinical through Phase III & early commercial manufacturing. More information can be obtained from www.qsvbiologics.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", and quoted on the Frankfurt, Berlin, Munich and Stuttgart Stock Exchanges under the same symbol. The Toronto and Frankfurt Stock Exchanges have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. Helix is not responsible for the information contained in referenced or linked websites, and such information does not form part of this press release. This News Release contains certain forward-looking statements regarding the Company's development of L-DOS47, which statements can be identified by the use of forward-looking terminology such as "to develop", "believe", "expected", "will accelerate", "upcoming", "potential" or variations thereon, or that events "can", "should" or "will" occur, or comparable terminology referring to future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and Helix's actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including without limitation, uncertainty whether the manufacturing activities will be successful; uncertainty whether further preclinical and/or clinical studies will be undertaken successfully or at all, uncertainty whether L-DOS47 developed or commercialized successfully; the occurrence and success of which cannot be assured; product liability and insurance risks; research & development risks, the risk of technical obsolescence; the need for further regulatory approvals, which may not be obtained in a timely matter or at all; intellectual property risks; marketing/manufacturing and partnership/strategic alliance risks; the effect of competition; uncertainty of the size and existence of a market opportunity for Helix's products; uncertainty as to whether the Company's products will be successfully commercialized, or at all; Helix's need for additional future capital, which may not be available in a timely manner or at all; as well as a description of other risks and uncertainties affecting Helix and its business, as contained in news releases and filings with the Canadian Securities Regulatory Authorities, any of which could cause actual results to vary materially from current results or Helix's anticipated future results. Forward-looking statements are based on the beliefs, opinions 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 should those beliefs, opinions or expectations, or other circumstances change.
