Helix BioPharma Corp. Completes Data Review of First Four Cohorts of Its Phase I/II Clinical Study for Lung Cancer Drug Candidate L-DOS47

AURORA, ON--(Marketwired - Oct 15, 2013) - Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced it has completed its interim review of the Company's ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland (the "LDOS002 Study"). This review was not a formal analysis of data, but a review of safety and clinical parameters collected during the study to date.

Enrollment has completed for the first four dosing cohorts. Each cohort enrolled and dosed three patients. Dose levels were increased at each new cohort following a review of safety data from the previous cohort by the Trial Steering Committee. The Cohort 4 dose level of 0.46 micrograms/kg patient body weight is at the lower level of the theoretically calculated minimum effective dose as determined from animal modeling.

All 12 patients treated met study entry criteria and were histologically confirmed non-squamous Non-small Cell Lung Cancer (NSCLC) late stage (Stage IIIb (n=5) or Stage IV (n=7)) patients refractory to previous treatments with approved lines of chemotherapy.

Patients enrolled in the study received a 30 minute intravenous infusion of L-DOS47 weekly for two weeks followed by one weeks' rest (one treatment cycle is 3 weeks). Cycles with L-DOS47 continued until the patient experienced disease progression, unacceptable toxicity, withdrew consent, or completed four treatment cycles and did not wish to continue with additional cycles, whichever occurred first. After four cycles, patients could continue to receive L-DOS47 for as long as there was sustained clinical benefit and it was well tolerated, in the discretion of the treating investigator and in consultation with the medical monitor.

L-DOS47 was well tolerated for all patients treated within all cohorts. None of the treatment-related adverse events reported to date has met the definition of a dose-limiting toxicity. No infusion or anaphylactic reactions have been reported. Adverse events reported to date are those normally expected for the population under study.

A review of available pharmacokinetic (PK) and immunogenicity data showed that these data so far are consistent with trends seen within pre-clinical animal studies of L-DOS47. A formal PK analysis will be conducted pending the collection of all PK data at the completion of the study.