September 9, 2013
(Aurora, Ontario) – Helix BioPharma Corp. (TSX, FSE: “HBP”), a biopharmaceutical company developing drug candidates for the treatment of cancer, today announced that it has completed patient enrolment in the fourth cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 and will perform an interim review of data collected for all subjects enrolled to date. The interim review will focus on safety, tolerability and other clinical parameters of the Company’s lead clinical candidate, L-DOS47 for the treatment of non-small cell lung cancer. Presentation to the Trial Steering Committee is expected to occur in October of 2013, after the opening of enrollment into the 5th cohort.
“We are currently dosing patients in our fourth cohort”, said Rob Verhagen, Chief Executive Officer of Helix. “The L-DOS47 dose levels used on patients in the fourth cohort represent the first dose which we believe to be within the range of theoretical minimum effective dose. Based on animal studies, the human equivalent theoretical minimum effective dose was calculated at 0.40 to 1.55 micrograms/kg, and the fourth cohort began doses of 0.46 micrograms/kg. This interim data review will allow the Company to better understand the performance of our lead drug candidate L-DOS47 and in turn help us develop next steps in our clinical development path of this important candidate”.
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 (“NSCLC”) in Helix’s ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland.
The Phase I/II clinical study is an open-label study to evaluate the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47, initially as a monotherapy, in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb/IV NSCLC.
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”.
Helix BioPharma Corp.
Tel: 905 841-2300
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 potential benefits of Helix’s DOS47 platform in the treatment of cancer and the anticipated scope of and timing for the completion of Helix’s interim review of data collected in connection with Helix’s ongoing Phase I/II clinical study in Poland. Forward-looking statements, which may be identified by words including, without limitation, “will”, “intends”, “expected” and other similar expressions, are intended to provide information about management’s current plans and expectations regarding future 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 inherent uncertainty involved in scientific research and drug development; (ii) the risks associated with delay or inability to complete clinical trials successfully; (iii) need to secure additional financing on terms satisfactory to Helix or at all; (iv) clinical trials that yield negative results, or results that do not justify future clinical development, including that the Polish Phase I/II clinical trial for L-DOS47 will yield negative results; and (v) 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 with the Canadian Securities Administrators 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.
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.