AURORA, ON--(Marketwired - Jan 21, 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 opening of patient screening in the second dosing cohort of its ongoing U.S. study of L-DOS47 in combination treatment with pemetrexed/carboplatin (“LDOS001").
The Safety Review Committee (“SRC”) reviewed safety data from the first dosing cohort and recommended that Helix begin enrollment of patients into the second dosing cohort of study LDOS001. Patients enrolled in the second dosing cohort will receive the next L-DOS47 dose level which is 0.78 micrograms of L-DOS47 per kilogram of patient body weight.
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 the United States and Poland and, as a treatment for certain patients with non-small cell lung cancer (“NSCLC”).
LDOS001 is a Phase I, open-label, dose escalation study being conducted in the United States at three centers: The University of Texas, M.D. Anderson Cancer Centre, Penn State Milton S. Hershey Medical Center; and University Hospitals Case Medical Center. 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.
LDOS002 is an open-label Phase I/II clinical study being conducted in Poland 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. Patients are being enrolled in the fifteenth dosing cohort at a dose of 10.19 micrograms of L-DOS47 per kilogram of patient body weight.
