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news.Canada-based Helix BioPharma has opened patient screening for the 15th dose level cohort in its ongoing phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland (LDOS002).
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L-DOS47 is the company’s first immunoconjugate based drug candidate in development based on its DOS47 platform technology designed to use a new approach to amend the microenvironmental conditions of cancer cells in a method that leads to their destruction.
After completing the safety review of cohort 14, the trial steering committee recommended that Helix begin enrollment of patients into the cohort of LDOS002.
Earlier, the Central Ethics Committee and the Polish Competent Authority had approved the dosing up to cohort 16, based on safety information provided by the company.
Following this, the trial steering committee recommended dose escalation of 10.19 µg/kg for cohort 15 and 13.55 µg/kg for cohort 16 assuming there are no safety issues.
The company will move into phase II portion of the study as soon as maximum tolerated dose (MTD) is observed or after concluding cohort 16.
At present, L-DOS47 is being clinically evaluated in two clinical studies as a treatment for certain patients with non-small cell lung cancer (NSCLC), in Poland as well as in the US.
The open-label phase I/II clinical study LDOS002 is being conducted in the country in order to assess the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47 in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb/IV NSCLC.