Helix Biopharma Corp. Submits L-DOS47 Clinical Trial Application With Health Canada

AURORA, ON--(Marketwired - May 14, 2014) - Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced the recent submission of a Clinical Trial Application with Health Canada for approval to initiate a Phase I clinical trial with L-DOS47. The study is entitled "A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Vinorelbine in Patients with Metastatic or Advanced Solid Tumours.

"This is the next step in the development of L-DOS47," said Robert Verhagen, President and Chief Executive Officer of Helix. "Acidic pH microenvironment may limit the effectiveness of weakly basic cytotoxic drugs employed in the treatment of solid tumours. The possibility of combining L-DOS47 with a weakly basic agent like vinorelbine may improve therapeutic outcomes for cancer patients."

L-DOS47 is Helix's first immunoconjugate-based drug candidate in development based upon the Company's novel DOS47 technology, which is designed to use an innovative approach to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction. L-DOS47 is currently being clinically evaluated as a treatment for certain patients with non-small cell lung cancer. The Company currently has a European Phase I/II L-DOS47 monotherapy clinical trial ongoing in Poland and has recently received approval from the U.S. Food and Drug administration for a Phase I clinical trial of L-DOS47 in combination with pemetrexed/carboplatin.

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 novel L-DOS47 new drug candidate and its Topical Interferon Alpha-2b. Helix is currently listed on the TSX and FSE under the symbol "HBP".  

Forward-Looking Statements and Risks and Uncertainties

This news release contains certain forward-looking statements and information (collectively, "forward-looking statements") within the meaning of applicable Canadian securities laws, including with respect to the possible outcomes of combining L-DOS47 with basic agents. Forward-looking statements, which may be identified by words including, without limitation, "may", and other similar expressions, are intended to provide information about management's current plans and expectations regarding Helix's business and operations.

Although Helix believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties that may cause actual results or events to differ materially from those anticipated and no assurance can be given that these expectations will be realized, and undue reliance should not be placed on such statements. Risk factors that could cause actual results or events to differ materially from the forward-looking statements include, without limitation, (i) the rejection by Health Canada of the Company's Clinical Trial Application; (ii) the need to secure additional financing in order to initiate the proposed Canadian Phase I clinical trial, and that such financing may not be available on terms satisfactory to Helix or at all; (iii) the potential therapeutic outcomes from combining L-DOS47 with a weakly basic agent like vinorelbine; and (iv) those risks and uncertainties affecting the company as more fully described in Helix's most recent Annual Information Form, including under the headings "Forward-Looking Statements" and "Risk Factors", filed under Helix's profile on SEDAR at www.sedar.com (together, the "Helix Risk Factors"). Certain material factors and assumptions are applied in making the forward-looking statements, including, without limitation, that Health Canada will approve Helix's Clinical Trail Application, that Helix is able to obtain financing on terms satisfactory to it (including the funding required to initiate the proposed Canadian Phase I clinical trial following approval by Health Canada) and that the Helix Risk Factors will not cause Helix's actual results or events to differ materially from the forward-looking statements.

Forward-looking statements and information are based on the beliefs, assumptions and expectations of Helix's management on the date of this news release, 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.