The Central Register of Clinical Trials at the Polish Ministry of Health has approved Helix BioPharma for conducting its intended Phase I/II clinical trial to evaluate the tolerability, safety and efficacy of its experimental drug L-DOS47 to treat lung cancer.
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Based on company’s DOS47 technology, L-DOS47 is intended to function by leveraging a natural process in the body called the urea cycle to produce an anti-cancer effect.
Th planned Phase I/II clinical trial is an open-label trial to investigate the ascending doses of L-DOS47 as a monotherapy, or as a combined drug with chemotherapy or radiotherapy, in patients who are suffering from inoperable, locally advanced, recurrent or metastatic, non-squamous, stage III/IV NSCLC.
Helix president John Docherty said the planned Phase I/II clinical study will employ a multi-arm design, intended to allow Helix to study the safety and preliminary efficacy of L-DOS47, both as a stand-alone therapy and in various combination chemotherapy or radiation therapy regimens.
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