Helix Announces Initiation of First Clinical Site for US Study

AURORA, ON--(Marketwired - Dec 22, 2014) -  Helix BioPharma (TSX: HBP) (FRANKFURT: HBP) announced today that its United States Phase I study of L-DOS47 in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous non-small cell lung cancer ("LDOS001") has been initiated at The University of Texas MD Anderson Cancer Center in Houston, Texas. Helix also anticipates the participation of two additional sites in the United States. Helix anticipates that the first patient will be enrolled in the LDOS001 study in the first quarter of 2015.

LDOS001 is a Phase I, open label, dose escalation study of the company's lead product L-DOS47. 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. Other exploratory objectives include the evaluation of the L-DOS47 pharmacokinetics and immunogenicity.

Update of European Phase I/II clinical study

On September 30^th, 2014, the company announced that it completed its interim data review of the first eight cohorts of the Company's ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland ("LDOS002"). The review included all available data, including patient demographics, safety assessments, pharmacokinetics, immunogenicity and radiological tumor assessments. The following observations were made:

• Adverse events reported are those expected for the investigational product and population under study;
• No dose limiting toxicities reported;
• Stable disease observed in radiological assessments of 12 of 24 (50%) of patients treated;
• Two patients completed 6 cycles of treatment; and
• Pharmacokinetic and safety data supports continued dose escalation.

To-date, a total of 33 patients have been dosed in the LDSO002 study, with patients currently being dosed in the 10^th dosing cohort at a dose level of 2.45 µg/kg. A Trial Steering Committee Meeting is anticipated in January 2015 to review safety data and determine if continued dose escalation is warranted.