Gil Roth10.15.13
Helix BioPharma has completed the interim review of its ongoing Phase I/II study of L-DOS47 in Poland. The review was not a formal analysis of data, but a review of safety and clinical parameters collected during the study to date.
Enrollment has completed for the first four dosing cohorts. Each cohort enrolled and dosed three patients. Dose levels were increased at each new cohort following a review of safety data from the previous cohort by the Trial Steering Committee.
All 12 patients treated met study entry criteria and were histologically confirmed non-squamous Non-small Cell Lung Cancer (NSCLC) late stage patients refractory to previous treatments with approved lines of chemotherapy. L-DOS47 was well tolerated for all patients treated within all cohorts. None of the treatment-related adverse events reported to date has met the definition of a dose-limiting toxicity. No infusion or anaphylactic reactions have been reported. Adverse events reported to date are those normally expected for the population under study.
A review of available pharmacokinetic (PK) and immunogenicity data showed that these data so far are consistent with trends seen within pre-clinical animal studies of L-DOS47. A formal PK analysis will be conducted pending the collection of all PK data at the completion of the study.
Helix plans to complete the enrollment of the Phase I component of this study by the summer 2014. L-DOS47 is Helix's first immunoconjugate-based drug candidate in development based upon the company's DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.
Enrollment has completed for the first four dosing cohorts. Each cohort enrolled and dosed three patients. Dose levels were increased at each new cohort following a review of safety data from the previous cohort by the Trial Steering Committee.
All 12 patients treated met study entry criteria and were histologically confirmed non-squamous Non-small Cell Lung Cancer (NSCLC) late stage patients refractory to previous treatments with approved lines of chemotherapy. L-DOS47 was well tolerated for all patients treated within all cohorts. None of the treatment-related adverse events reported to date has met the definition of a dose-limiting toxicity. No infusion or anaphylactic reactions have been reported. Adverse events reported to date are those normally expected for the population under study.
A review of available pharmacokinetic (PK) and immunogenicity data showed that these data so far are consistent with trends seen within pre-clinical animal studies of L-DOS47. A formal PK analysis will be conducted pending the collection of all PK data at the completion of the study.
Helix plans to complete the enrollment of the Phase I component of this study by the summer 2014. L-DOS47 is Helix's first immunoconjugate-based drug candidate in development based upon the company's DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.