SOURCE: Helix BioPharma Corp.

Helix BioPharma Corp.

November 04, 2015 07:30 ET

Helix BioPharma Corp. Initiates Enrollment for Fourteenth Cohort in Polish Phase I/II Clinical Study of Its L-DOS47 Lung Cancer Drug

AURORA, ON--(Marketwired - Nov 4, 2015) - 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 fourteenth dose level cohort in the Company's ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland ("LDOS002").

The Trial Steering Committee has completed the safety review of Cohort 14 and recommended that Helix begin enrollment of patients into the fourteenth (14) cohort of LDOS002.

During the dosing of the thirteenth (13th) cohort, one patient experienced a serious adverse event that meets the definition of a Dose Limiting Toxicity ("DLT"). The patient was withdrawn from further dosing and subsequently recovered from the event. In accordance with the protocol, Cohort 13 was expanded to enroll three new patients. No new DLT was observed.

Based on safety information provided by Helix, the Central Ethics Committee and the Polish Competent Authority have previously approved the dosing of patients up to Cohort 16. This allows the Trial Steering Committee to recommend dose escalation of 7.66 µg/kg for Cohort 14, 10.19 µg/kg for Cohort 15 and 13.55 µg/kg for Cohort 16, assuming there are no safety issues. It is the Company's intention not to dose beyond Cohort 16. Rather, Helix will move into the Phase II portion of the study as soon as Maximum Tolerated Dose ("MTD") is observed or when Cohort 16 is completed.

"I am pleased to see that we are nearing the completion of Phase I portion of LDOS002." said Gary Littlejohn, Interim CEO of Helix. "We are actively planning for Phase II and looking forward to opening that portion of the study."

About L-DOS47

L-DOS47 is Helix's first immunoconjugate based drug candidate in development based on the Company's novel DOS47 platform 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.

About L-DOS47 clinical development

L-DOS47 is currently being clinically evaluated in two clinical studies, in Poland and in the United States, as a treatment for certain patients with non-small cell lung cancer ("NSCLC").

LDOS002 is an open-label Phase I/II clinical study being conducted in Poland 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 fourteenth cohort will receive the next L-DOS47 dose level as planned in the study protocol, which is 7.66 micrograms of L DOS47 per kilogram of patient body weight.

LDOS001 is a Phase I, open-label, dose escalation study being conducted in the United States at three centers: The University of Texas, M.D. Anderson Cancer Centre, Penn State Milton S. Hershey Medical Center, and University Hospitals Case Medical Center. 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.

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, the intention of the Company not to enrol patients in the Phase I portion of LDOS002 beyond Cohort 16, the intention to commence Phase II of LDOS002 following MTD being observed or the reaching of Cohort 16, whichever occurs first, which may be identified by words including, without limitation, "will", "intend", "planning" and other similar expressions, are intended to provide information about management's current plans and expectations regarding the conduct of the clinical study 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, 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 (v) 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.

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