AURORA, ON -- (Marketwired) -- 07/21/16 -- Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP) ("Helix" or the "Company"), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, is pleased to announce that its wholly owned subsidiary, Helix Polska Sp. z o.o. ("Helix Polska" or "Subsidiary") has finalized the Grant Funding Agreement ("Agreement") with the Polish National Centre for Research and Development ("PNCRD") to develop V-DOS47 in breast cancer up to and including a phase I/IIa clinical trial.
Funding from the PNCRD will go towards the development of a new, effective and highly specific breast cancer therapy with potentially low toxicity, based on the DOS47 patented technological platform, modifying the tumor microenvironment and immunological response through a change of pH.
The total cost of implementing the project is PLN19,794,415.53. Based on the Agreement, certain expenditures made commencing on March 1st, 2016 are eligible for reimbursement with the final reimbursement submission to be made no later than September 30th, 2021. Of the total project costs, the public subsidy portion represents PLN12,506,955.77 (~CAD4,089,941.63). Helix Polska is required to spend PLN4,437,459.76 (~CAD1,451,108.63) towards eligible project expenditures. The public subsidy funds may be drawn in advance or on a reimbursement basis, with varying criteria and timelines on justification of claims being made by the Subsidiary against the PNCRD for funding of the V-DOS47 development program in Poland. The Agreement may be terminated by either party upon one month's written notice and must also state the grounds for which the Agreement is being terminated. In certain cases of termination, the Subsidiary may be obligated to return the received financial support in full within fourteen days of the day notice is served with interest.
"The grant will assist in accelerating the research and development activities of our Polish subsidiary and enable us to advance a second immuno-oncology drug candidate from our DOS47 technology platform, to the clinic," said Dr. Sven Rohmann, Chief Executive Officer of Helix. Dr. Heman Chao, Chief Scientific Officer added that, "this grant will further enable us to expand our immuno-oncology pipeline in collaboration with world class scientists and clinical researchers in Poland."
About V-DOS47
V-DOS47 is an antibody DOS47 conjugate that targets the vascular endothelial growth factor 2 receptor (VEGFR2). V-DOS47 is the second immuno-oncology drug candidate derived from the Company's DOS47 technology platform.
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. Helix is currently listed on the TSX and FSE under the symbol "HBP".
About Helix Polska Sp. z o.o.
Helix Polska Sp. z o.o., a wholly owned subsidiary of Helix BioPharma Corp, is a research stage company that specializes in the field of oncology therapeutic development. Its primary focus will be the development of V-DOS47, a tumor microenvironment modifying agent, for the treatment of breast cancer.
About the Polish National Center for Research and Development
The National Centre for Research and Development is the implementing agency of the Minister of Science and Higher Education. It was appointed in the summer 2007 as an entity in charge of the performance of the tasks within the area of national science, science and technology and innovation policies. When it was founded, it was the first entity of this type, created as the platform of an effective dialogue between the scientific and business communities. The activity of the Centre is funded by the National Treasury and the European Union. (http://www.ncbir.pl/en/)
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, without limitation, those relating to the grant from the Polish National Centre for Research and Development to develop V-DOS47 and those relating to Helix's research and development activities, including the development of V-DOS47, which may be identified by words including, without limitation, "will", "may", "potentially", "develop", "accelerating", "advance" and other similar expressions, are intended to provide information about management's current plans and expectations regarding the conduct of the clinical study.
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 inherent uncertainty involved in scientific research and drug development; (ii) the risks that the conditions to the grant are not fulfilled or that any required approvals are not obtained; (iii) the need to secure additional financing on terms satisfactory to Helix or at all; and (iv) those risks and uncertainties affecting the company as more fully described in Helix's most recent Annual Report, 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 or assumptions are applied in making the forward-looking statements, including, without limitation, that the Helix Risk Factors will not cause Helix's actual results or events to differ materially from the forward-looking statements. These cautionary statements qualify all such 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.
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