Helix BioPharma Corp. Reports on Advancement of Its Lung Cancer Drug Candidate L-DOS47

AURORA, ON--(Marketwired - Mar 3, 2016) - Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced the Trial Steering Committee has completed a review of safety data and recommended the opening of patient screening for the sixteenth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland ("LDOS002").

If there are no dose limiting toxicities reported at the sixteenth dose level (13.55 µg/kg), Helix will have determined the Phase II dose of L-DOS47 and will immediately move into the next study phase of the LDOS002 study in Poland. The primary objective of the Phase II study is to make a preliminary assessment of efficacy of L-DOS47 in patients with non-squamous non-small cell lung cancer.

"We are encouraged by the progress we've made to-date," said Dr. Zbigniew Markowski, Helix's Chief Executive Officer. "We look forward to initiating the LDOS002 Phase II study in Poland."

Enrolment in the second dosing cohort of the U.S. study LDOS001 is now closed. Following collection of safety data, the Safety Review Committee will meet to decide on the escalation of L-DOS47 to the third dosing cohort (1.04 µg/kg). There have been no dose limiting toxicities reported to-date and L-DOS47 continues to be well tolerated by patients. 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 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 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 under the direction of Dr. Dariusz Kowalski at The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology as the overall coordinating investigator, together with four other principal investigators: Prof. Cezary Szczylik, MD, PhD at the Military Medical Institute, Prof. Elzbieta Wiatr, MD, PhD at the National Tuberculosis and Lung Diseases Research Institute, Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and Prof. Rodryg Ramlau, MD, PhD at the Department of Oncology, Poznan University of Medical Science.