Helix BioPharma Corp. Completes Data Review of First Four Cohorts of Its Phase I/II Clinical Study for Lung Cancer Drug Candidate L-DOS47 - Seite 2

Radiological assessments for all patients were performed prior to the first dose to establish a baseline, and every 6 weeks thereafter to evaluate disease progression as defined by RECIST criteria (v1.1). The RECIST criteria are unified, easily applicable criteria for measuring tumour response in Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). Patients assigned a status of Progressive Disease following an assessment were withdrawn from the study. Patients assigned a status of Stable Disease or better were allowed to continue.

At least one patient in each of the four cohorts dosed had a radiological assessment of Stable Disease. Duration of treatment increased with each dose escalation up to Cohort 3 and dosing in Cohort 4 remains ongoing. One patient in Cohort 3 was dosed for 6 cycles without disease progression. None of the patients treated to date have had a partial or complete response as defined by RECIST v1.1 definition.

"We sincerely thank all of the Investigators who participated in this review. Their contribution to this process and their commitment to this ongoing study is invaluable, and this review will help us greatly in designing further studies for the continued development of this important drug candidate for Helix", stated Rob Verhagen, CEO of Helix BioPharma Corp. With no safety concerns to date and with enrollment on target, we expect to complete the enrollment of the Phase I component of this study by the summer 2014."

L-DOS47 is Helix's first immunoconjugate-based drug candidate in development based upon the Company's novel DOS47 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. L-DOS47 is currently being clinically evaluated as a treatment for certain patients with NSCLC.

About the Clinical Study

The Phase I/II clinical study is an open-label 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 commenced with a starting dose of 0.12 micrograms of L-DOS47 per kilogram of patient body weight in the first patient cohort.