The Trial Steering Committee (TSC) has recommended Helix BioPharma (Helix), a clinical stage biopharmaceutical company, to begin a Phase II portion of LDOS002 study.
LDOS002 is an open-label Phase I/II clinical trial that is designed to assess 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 non-small cell lung cancer (NSCLC).
Currently, the study is being conducted at five centres in Poland, the Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Military Medical Institute, National Tuberculosis and Lung Diseases Research Institute, Mazovian Centre of Pulmonary Diseases and Tuberculosis in Otwock and Department of Oncology, Poznan University of Medical Science.
Helix chief medical officer Steve Demas said: "We have now determined the Phase II dose and monotherapy regimen of L-DOS47 for patients that have limited treatment options in our LDOS002 study."
A maximum of 45 patients will be enrolled in the Phase II open-label, non-randomised study, which is designed to make a preliminary assessment of efficacy of L-DOS47 in patients with NSCLC.
Currently under development, L-DOS47 is Helix's first immunoconjugate based drug and is based on the company's DOS47 platform technology, which is designed to use a new approach to amend the microenvironmental conditions of cancer cells in a manner that leads to their destruction.
L-DOS47 is now being clinically evaluated in two clinical studies in Poland and in the US, as a treatment for certain patients with NSCLC.
Last September, Helix reported results from the ongoing LDOS002 study, and results from patients enrolled in the first 12 dosing cohorts showed that L-DOS47 was well tolerated at dose levels studied until that period.
21 out of the 40 patients enrolled in the study had an overall response of 'stable disease' after completion of two cycles of L-DOS47, whilst 11 of the 21 patients had a response of 'stable disease' after completing four cycles of L-DOS47.
It is reported that one patient in the ninth dosing cohort was dosed for ten cycles, which includes around seven months, without disease progression.
Helix is conducting the LDOS001, a Phase I, open-label, dose escalation study, at three centres in the US: University of Texas, M.D. Anderson Cancer Centre, Penn State Milton S. Hershey Medical Centre and University Hospitals Case Medical Centre.
The primary objective of the study is to identify the safety and tolerability of L-DOS47 in combination treatment with pemetrexed / carboplatin.