TORONTO, ONTARIO–(Marketwired – July 25, 2017) – Helix BioPharma Corp. (TSX:HBP)(FRANKFURT:HBP) (“Helix” or the “Company”), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, today announced the opening of patient screening in the third dosing cohort of its ongoing U.S. study of L-DOS47 in combination treatment with pemetrexed/carboplatin (“LDOS001”).
“We are encouraged that L-DOS47 continues to be safe and well tolerated by patients”, said Heman Chao, Helix’s Chief Executive Officer”.
The Safety Review Committee (“SRC”) reviewed safety data from the second dosing cohort and recommended that Helix begin enrollment of patients into the third dosing cohort of study LDOS001. Patients enrolled in the third dosing cohort will receive the next L-DOS47 dose level which is 1.50 micrograms of L-DOS47 per kilogram of patient body weight.
About L-DOS47
L-DOS47 is an 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 the United States and Poland and, as a treatment for certain patients with non-small cell lung cancer (“NSCLC”).
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.
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, as a monotherapy, in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb/IV NSCLC.
About Helix BioPharma Corp.
Helix BioPharma Corp. is an immuno-oncology 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. Helix is currently listed on the TSX and FSE under the symbol “HBP”.
Cautionary Statements
This news release may contain forward-looking statements and information (collectively, “forward-looking statements”) within the meaning of applicable Canadian securities laws including, without limitation, those relating to Helix’s operations and strategy and its research and development activities. These statements generally can be identified by forward looking words such as “ongoing”, “encouraged”, “continues”, “will” or “modify”, or the negative thereof or similar variations.
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. Factors that could cause actual results or events to differ materially from the forward-looking statements include, without limitation, risks inherent in Helix’s research and development activities and 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, estimates or assumptions have been applied in making forward-looking statements including, without limitation, the safety and efficacy of the Company’s drug product candidates; that sufficient financing will be obtained in a timely manner to allow the Company to continue operations and implement its clinical trials in the manner and on the timelines anticipated; the timely provision of services and supplies or other performance of contracts by third parties; future costs; the absence of any material changes in business strategy or plans; the timely receipt of required regulatory approvals and strategic partner support and that the factors described in the Helix Risk Factors will not cause the Company’s actual results or events to differ materially from the forward-looking statements. These cautionary statements qualify all such forward-looking statements.
Forward-looking statements and information are based on the beliefs, assumptions, opinions, plans and expectations of Helix’s management on the date of this news release, and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions, plans or expectations, or other circumstances change, except as required by law.
