Helix Biopharma Awarded U.S. Patent for DOS47 Adjunct Chemotherapy Applications

AURORA, ON, Sept. 17 /PRNewswire-FirstCall/ - Helix BioPharma Corp. announced today the issuance of its second DOS47 patent (U.S. Patent # 7,264,800) from the United States Patent & Trademark Office, describing a method and composition for combining targeted DOS47 therapeutics with weakly basic chemotherapeutic drugs in adjunct treatment applications.

“This patent offers a significant extension to Helix’s DOS47 intellectual property position, opening up the possibility for expanded commercial opportunities,” said Dr. Donald H. Segal, President and CEO of Helix. “We believe there is significant market potential to combine DOS47-based therapeutics with certain chemotherapeutic drugs in so-called adjunct regimens because DOS47 therapy is designed to counteract tumor acidity. Tumor acidity is a property that otherwise makes it difficult for weakly basic chemotherapeutics to penetrate cancer cells and function effectively.”

With the granting of this second DOS47 patent, Helix now has patent protection covering the use of targeted DOS47-based therapeutics alone and in certain combined chemotherapy applications. Moving forward, the Company intends to pursue the development of DOS47 therapies for both applications, with a view to maximizing its DOS47 commercialization potential.

At present, Helix is focused on the development of its first DOS47-based cancer therapeutic (“L-DOS47") which specifically targets lung adenocarcinoma. Helix has previously presented scientific findings which demonstrated the ability of L-DOS47 to destroy lung cancer cells alone and synergistically with selected chemotherapeutic compounds. Helix continues to advance its manufacturing and preclinical development programs with a view to phase I human clinical testing. With this newly issued patent, the Company is well-positioned to potentially broaden its late stage clinical development program to include both monotherapy and combined chemotherapy applications for L-DOS47.

About L-DOS47

L-DOS47 combines Helix’s proprietary DOS47 new drug candidate with a highly specific single domain 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. By inducing an alkalizing effect locally at the tumor site, L-DOS47 and other targeted DOS47-based cancer therapeutics may also promote enhanced cancer cell uptake of weakly basic chemotherapeutic compounds for more efficient and effective chemotherapeutic action.

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, for the treatment of conditions caused by the human papilloma virus, and its novel L-DOS47 new drug product candidate for the treatment of lung adenocarcinoma. Helix is listed on the Toronto Stock Exchange under the ticker symbol “HBP”.

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. This News Release contains certain forward-looking statements and information regarding Helix’s DOS47 drug development program. Forward-looking statements and information can be identified by the use of forward-looking terminology such as “possibility”, “opportunities”, “we believe”, “potential”, “is designed to”, “moving forward”, “intends”, “to pursue”, “with a view to”, “continue”, “is believed”, “may”, “will”, “theorized”, or variations thereon or comparable terminology referring to future events or results. Forward looking statements and information are statements and information 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 L-DOS47 will be developed successfully as a drug or at all; uncertainty whether DOS47 will be developed as a therapeutic for any other cancers; the risk that the U.S. patents referred to in this News Release may be challenged and that the patents, or a portion of them, may subsequently be struck down; uncertainty whether L-DOS47 or any other DOS47-based cancer therapeutic in an adjunct regimen with other chemotherapeutics will be effective or successfully commercialized; the need to partner with a maker of a weakly basic chemotherapeutic to be able to form an adjunct regimen, which is not assured; research & development risks, including the risk that early R&D results may not be repeated in later R&D; the risk of technical obsolescence; the need for regulatory approvals, which may not be obtained in a timely matter or at all; the need for clinical trials, the occurrence and success of which cannot be assured; intellectual property risks; the need to manufacture to regulatory standards and risks inherent in upscaling; marketing and partnership/strategic alliance risks; the effect of competition; 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 Helix’s latest Annual Information Form and other filings with the Canadian Securities Regulatory Authorities 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, 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 or information should those beliefs, opinions or expectations, or other circumstances change.

Helix BioPharma Corp.

CONTACT: Investor Relations, Christina Bessant, The Equicom Group Inc.,Tel: (416) 815-0700 ext. 269, (800) 385-5451, Fax: (416) 815-0080, Email:cbessant@equicomgroup.com; Media Relations, Benjamin Carmichael, RussoPartners LLC, Tel: (212) 845-4242, Fax: (212) 845-4260, Email:benjamin.carmichael@russopartnersllc.com, www.russopartnersllc.com