AURORA, ON--(Marketwired - July 15, 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 opening of patient screening for the ninth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland ("LDOS002"). This follows completion of the first treatment cycle in the three patients enrolled in the eighth dose level cohort, in which L-DOS47 therapy was well tolerated, as reviewed by the Trial Steering Committee.
"We would like to thank all the investigators for their continued support of the LDOS002 study in Poland," said Robert Verhagen, President and Chief Executive Officer of Helix. "With the continued dose escalation, now in the ninth dose level cohort for our Polish study, and the recent U.S. Food and Drug Administration approval of the LDOS001 Phase I study, the company will have taken an important step in the development of L-DOS47."
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").
LDOS002, which has been approved in Poland, 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 ninth cohort will receive the next L-DOS47 dose level as planned in the study protocol, which is 1.84 micrograms of L-DOS47 per kilogram of patient body weight.
LDOS001, which has been approved in the U.S., is an open-label Phase I dose escalation study of L-DOS47 in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous NSCLC.
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, without limitation, those relating to the total number of patients that will be enrolled in the Polish Phase I/II clinical study, which may be identified by words including, without limitation, "will", "may", "estimated", 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 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, 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) the Company's planned future U.S. Phase I clinical trial for L-DOS47; (iv) need to secure additional financing on terms satisfactory to Helix or at all; (v) 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 and/or that the approved U.S. Phase I clinical trial will yield negative results and that the information, if any, gained from higher dose levels in the Polish Phase I/II study will not be of use in future studies; and (vi) 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.
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.