Canada-based, clinical stage, biopharmaceutical company Helix BioPharma has dosed its first patient in the Phase ll component of study, LDOS002, evaluating the drug L-DOS47 to treat non-squamous, non-small cell lung cancer (NSCLC).
NSCLC is a type of epithelial lung cancer, which, along with small cell lung cancer (SCLC), is considered as the leading cause of cancer-related mortality in the US.
LDOS002 is an open-label Phase I/II clinical trial that will involve 45 patients 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 NSCLC.
Five Polish centres, including the Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, the Military Medical Institute, the National Tuberculosis and Lung Diseases Research Institute, the Mazovian Centre of Pulmonary Diseases and Tuberculosis in Otwock and the Department of Oncology, Poznan University of Medical Science, are undertaking the study.
Helix's L-DOS47 is claimed being the first immunoconjugate based drug based on the company's DOS47 platform technology, which is intended to be used as an approach to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.
The Phase I open-label, dose escalation study, LDOS001, has recently reported positive, recording a 37% decrease in the sum of the diameters of target lesions identified at baseline after administering the patient with four cycles of L-DOS47 in combination with pemetrexed / carboplatin, and an additional four cycles of L-DOS47 alone before the progression of their disease.
Image: An FNA specimen displaying squamous cell carcinoma. Photo: courtesy of Nephron.