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news.Canada-based biopharmaceutical firm Helix BioPharma has started enrolling patients for the eighth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy trial of its drug candidate L-DOS47 in Poland for the treatment of lung cancer.
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The initiation follows completion of the first treatment cycle in the three patients enrolled in the seventh dose level cohort, in which L-DOS47 therapy was well tolerated as reviewed by the Trial Steering Committee.
The company plans to start and submit to Polish regulatory authorities for approval a protocol amendment that would continue dose escalation for the Phase I component of the study beyond Cohort 8 in the event the maximum tolerated dose (MTD) is not reached in Cohort 8.
As previously disclosed, the planned enrollment in the trial depends on how many dose levels are required to reach MTD.
The company originally estimated that MTD would be reached after enrolling eight cohorts of three patients each; however, none of the treatment related adverse events reported to date have met the definition of a dose-limiting toxicity.
Helix president and chief executive officer Robert Verhagen said the company is pleased to see this safety profile for L-DOS47, and its application to continue dose escalation, if approved, will provide them with the ability to gather the best possible information for further continued development of its lead candidate.
"Higher doses evaluated in this study can potentially provide greater insight into its use in future safety and efficacy studies," Verhagen said.
"The company will provide a more detailed update on the status of the first seven patient cohorts by the end of the second calendar quarter of 2014."
The Phase I/II trial is designed to evaluate 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.
The trial started with a starting dose of 0.12 micrograms of L-DOS47 per kilogram of patient body weight in the first patient cohort.
Patients to be enrolled in the eighth group of the trial will be given the next L-DOS47 dose level as planned in the trial protocol, which is 1.38 micrograms of L-DOS47 per kilogram of patient body weight.