On April 30, 2019 Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immunooncology company developing innovative drug candidates for the prevention and treatment of cancer, has reported that the Trial Steering Committee ("TSC") reviewed safety data from the first dosing cohort of the Company’s LDOS003 study. No serious adverse events or dose limiting toxicities were observed (Press release, Helix BioPharma, APR 30, 2019, View Source [SID1234536460]). TSC recommended that Helix begin enrollment of patients into the second dosing cohort.
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LDOS003 is a Phase II, open-label, randomized study of immunoconjugate L-DOS47 in combination with vinorelbine and cisplatin as compared to vinorelbine and cisplatin alone in patients with lung adenocarcinoma. The study is divided into two parts. In part I, the maximum tolerated dose of L-DOS47, when given in combination with vinorelbine/cisplatin, will be determined. Cohorts of 3 patients will be recruited into three dosing cohorts (6, 9 and 12 µg/kg). All patients at a given dose level must complete the first treatment cycle (3-week period) before escalation in subsequent patients can proceed. In part II, after the maximum tolerated dose of L-DOS47 in combination with vinorelbine/cisplatin has been determined, a further 118 patients will be randomized (1:1) to receive L-DOS47 in combination with vinorelbine/cisplatin, or vinorelbine/cisplatin alone.
"We are very encouraged that the first dosing cohort of this L-DOS47 phase II study in combination with chemotherapy has been completed" said Heman Chao, Helix’s Chief Executive Officer. "We look forward to receiving more data as we advance the L-DOS47 development program."
About L-DOS47 clinical development
L-DOS47 is currently being clinically evaluated in three clinical studies, in the United States, Poland and Ukraine 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 the 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. Patient enrollment is active for this study.
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. Patient enrollment has completed for this study.
LDOS003 is a phase II, open-Label, randomized study of L-DOS47 in combination with vinorelbine/cisplatin as compared to vinorelbine/cisplatin alone in patients with Lung adenocarcinoma. The 2 primary objectives of the study include safety, tolerability and efficacy of L-DOS47 in this combination treatment. Patient enrollment is about to commence for this study.