SOURCE: Helix BioPharma Corp.

Helix BioPharma Corp.

April 28, 2016 07:30 ET

First Patient Enrolled in Phase II Study of L-DOS47 in Non-Small Cell Lung Cancer

AURORA, ON--(Marketwired - Apr 28, 2016) - Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP) ("Helix" or the "Company"), a clinical stage biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced that the first patient has been enrolled in the Phase II component of study LDOS002.

"We continue to build on the clinical experience that was gained from the Phase I component of the study," said Mr. Steve Demas, Helix's newly appointed Chief Medical Officer. Up to forty-five (45) patients will be enrolled in the Phase II open-label, non-randomized study designed to make a preliminary assessment of efficacy of L-DOS47 in patients with non-squamous non-small cell lung cancer ("NSCLC").

"We would like to thank the investigative sites for their continued commitment to the study," said Dr. Sven Rohmann, Chief Executive Officer of Helix.

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 NSCLC.

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 is being conducted at five Polish centers: the Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology, the Military Medical Institute, the National Tuberculosis and Lung Diseases Research Institute, the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and the Department of Oncology, Poznan University of Medical Science.

On September 8th, 2015, the company presented results from the ongoing LDOS002 study at the 16th World Conference on Lung Cancer held in Denver, Colorado. Results from patients enrolled in the first twelve dosing cohorts included:

  • L-DOS47 was well tolerated at dose levels studied to-date;
  • Twenty-one (21) of the 40 patients enrolled (52%) had an overall response of 'stable disease' after completion of two cycles of L-DOS47;
  • Eleven (11) of the 21 patients had a response of 'stable disease' after completing four cycles of L-DOS47;
  • One (1) patient in the 9th dosing cohort (1.84µg/kg) was dosed for 10 cycles (approximately 7 months) without disease progression.

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.

On March 3rd, 2016, the company reported on the progress of study LDOS001. A patient in the first dosing cohort received four cycles of L-DOS47 in combination with pemetrexed/carboplatin and an additional four cycles of L-DOS47 alone before progression of their disease. The best response reported for this patient was a 37% decrease in the sum of the diameters of target lesions identified at baseline.

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. 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 and the potential generation of valuable information by such further enrollment of patients, which may be identified by words including, without limitation, "will", "may", "anticipated", 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, that Helix's planned U.S. Phase I clinical trial for L-DOS47 proceeds in a manner and on the timelines anticipated by Helix, 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; 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. These cautionary statements qualify all such 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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