Helix BioPharma announced that the FDA approved an amendment to their phase I study, protocol LDOS001, to accelerate the dose escalation phase of the study.
Helix BioPharma (TSX:HBP) announced that the US Food and Drug Administration (FDA) approved an amendment to their phase I study, protocol LDOS001, to accelerate the dose escalation phase of the study.
As quoted in the press release:
In order to maximize the number of patients receiving a potentially active dose of L-DOS47, the study will implement an accelerated dose design up to 6µg/kg followed by a standard 3+3 design for the final two dosing cohorts, 9 and 12 µg/kg, respectively.
“This was a significant achievement in the advancement of the study,” said Steve Demas, Chief Operating Officer of Helix. “We will be able to move more rapidly through the escalation phase to doses of L-DOS47 that exhibited the best patient responses in the Phase I monotherapy study (“LDOS002″), recently completed in Poland. We are also planning on opening additional centers to further accelerate the completion of the study.”