Helix BioPharma Corp., a biopharmaceutical company developing drug candidates for the treatment of cancer, has completed patient enrolment in the fourth cohort in its ongoing phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 and will perform an interim review of data collected for all subjects enrolled to date. The interim review will focus on safety, tolerability and other clinical parameters of the company’s lead clinical candidate, L-DOS47 for the treatment of non-small cell lung cancer.
The presentation is expected to occur in October 2013 to the Trial Steering Committee, after the opening of enrollment into the 5th cohort.
“We are currently dosing patients in our fourth cohort”, said Rob Verhagen, chief executive officer of Helix. “The L-DOS47 dose levels used on patients in the fourth cohort represent the first dose which we believe to be within the range of theoretical minimum effective dose. Based on animal studies, the human equivalent theoretical minimum effective dose was calculated at 0.40 to 1.55 micrograms/kg, and the fourth cohort began doses of 0.46 micrograms/kg. This interim data review will allow the Company to better understand the performance of our lead drug candidate L-DOS47 and in turn help us develop next steps in our clinical development path of this important candidate.”
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 micro-environmental 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 non-small cell lung cancer (NSCLC) in Helix’s ongoing phase I/II clinical safety, tolerability and preliminary efficacy study of LDOS47 in Poland.
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.