AURORA, ON--(Marketwired - Apr 7, 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 eighth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland. This follows completion of the first treatment cycle in the three patients enrolled in the seventh dose level cohort, in which L-DOS47 therapy was well tolerated as reviewed by the Trial Steering Committee.
Helix intends to initiate and submit to Polish regulatory authorities for approval a protocol amendment that would continue dose escalation for the Phase I component of the study beyond Cohort 8 in the event the maximum tolerated dose ("MTD") is not reached in Cohort 8.
As previously disclosed, the planned enrolment in the study depends on how many dose levels are required to reach MTD. Helix originally estimated that MTD would be reached after enrolling eight cohorts of three patients each; however, none of the treatment related adverse events reported to date have met the definition of a dose-limiting toxicity.
"We are pleased to see this safety profile for L-DOS47, and our application to continue dose escalation, if approved, will provide us with the ability to gather the best possible information for further continued development of our lead candidate. Higher doses evaluated in this study can potentially provide greater insight into its use in future safety and efficacy studies," said Robert Verhagen, President and Chief Executive Officer of Helix. "The company will provide a more detailed update on the status of the first seven patient cohorts by the end of the second calendar quarter of 2014."
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").
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. 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 eighth cohort will receive the next L-DOS47 dose level as planned in the study protocol, which is 1.38 micrograms of L-DOS47 per kilogram of patient body weight.
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, the anticipated approval of the protocol amendment to permit the enrollment of patients beyond Cohort 8 of such study, the potential generation of valuable information by such further enrollment of patients and the anticipated timing for the delivery of an update on the status of the first seven patient cohorts, which may be identified by words including, without limitation, "will", "may", "estimated", "intends", 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) 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; (v) the potential that Polish regulatory bodies may not accept Helix's proposed protocol amendment to permit the enrollment of patients beyond Cohort 8 in a timely fashion or at all; 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 Polish regulatory bodies will accept Helix's proposed protocol amendment to permit the enrollment of patients beyond Cohort 8 on the timelines anticipated by Helix, and 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.