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Phone: (905) 841-2300
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April 7, 2015
HELIX BIOPHARMA CORP. INITIATES ENROLLMENT FOR TWELFTH COHORT IN POLISH PHASE I/II CLINICAL STUDY OF ITS LUNG CANCER DRUG CANDIDATE L-DOS47
(Aurora, Ontario) - Helix BioPharma Corp. (TSX, FSE: "HBP"), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced the opening of patient screening for the twelfth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland ("LDOS002").
The trial steering committee reviewed the safety data for the eleventh cohort and recommended that the Company begins enrollment into the twelfth cohort as no dose limiting toxicities were observed.
"We continue to be encouraged with the safety profile of L-DOS47 and we look forward to continued dose escalation, as we expect that this will provide more flexibility in later stages of clinical development", said Robert Verhagen, CEO of Helix.
On February 10, 2015, the Central Ethics Committee overseeing the Phase I clinical study in Poland approved additional dose levels in the Phase I component of the LDOS002 study in anticipation of continued dose escalation beyond the 4.33 µg/kg in Cohort twelve.
L-DOS47 is Helix's first immunoconjugate-based drug candidate in development based upon Helix'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").
L-DOS47 is currently being evaluated in two clinical studies.
LDOS002 is an open-label Phase I/II clinical 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. The study commenced with a starting dose of 0.12 micrograms of L-DOS47 per kilogram of patient body weight in the first patient cohort. Patients to be enrolled in the twelfth cohort will receive the next L-DOS47 dose level as planned in the study protocol, which is 4.33 micrograms of L-DOS47 per kilogram of patient body weight.
LDOS001 is a Phase I, open label, dose escalation study. The primary objective of the study is to determine the safety and tolerability of L-DOS47 in combination treatment with pemetrexed/carboplatin. The study will also evaluate the potential clinical benefit of L-DOS47 with
this combination. Other exploratory objectives include the evaluation of the L-DOS47 pharmacokinetics and immunogenicity.
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".
Investor Relations: Helix BioPharma Corp. Tel: 905 841-2300
This press release is not an offer of securities for sale in the United States. The Corporation's common shares have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent an exemption from registration thereunder.
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 total number of patients that will be enrolled in the Polish Phase I/II clinical study and the potential implications of continuing dose escalations on the flexibility of the clinical development for L-DOS47 in the future, , which may be identified by words including, without limitation, "continue", "expect" and other similar expressions, are intended to provide information about management's current plans and expectations regarding the conduct of the clinical studies of L-DOS47 and the other operations of Helix.
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, including that patient recruitment for the Polish Phase I/II clinical trial for L-DOS47 does not continue as scheduled or at all, that Helix's U.S. Phase I clinical trial for L-DOS47 proceeds in a manner and on the timelines anticipated by Helix and the long lead- times and high costs associated with obtaining regulatory approval to market any product which may result from successful completion of such trials; (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 that the information, if any, gained from higher dose levels in such study will not be of use in future studies; 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 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.
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.