US-based biopharmaceutical firm Helix BioPharma has opened patient screening for the ninth dose level group in its ongoing Phase I/II trial of L-DOS47 in Poland (LDOS002).
The open-label Phase I/II clinical trial is designed to assess 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 opening of patient screening follows completion of the first treatment cycle in the three patients enrolled in the eighth dose level group, in which L-DOS47 therapy was well tolerated, as reviewed by the Trial Steering Committee.
Helix president and chief executive officer Robert Verhagen said: "With the continued dose escalation, now in the ninth dose level cohort for our Polish study, and the recent US Food and Drug Administration approval of the LDOS001 Phase I study, the company will have taken an important step in the development of L-DOS47."
L-DOS47 is the company’s first immunoconjugate-based drug candidate being developed based on a new DOS47 technology, which is designed to use an innovative approach to modify the microenvironmental conditions of cancer cells.
L-DOS47 is currently being clinically assessed as a treatment for certain patients with non-small cell lung cancer (NSCLC).
According to the company, patients to be enrolled in the ninth group will receive the next L-DOS47 dose level as planned in the trial protocol, which is 1.84mcg of L-DOS47 a kilogram of patient body weight.
Approved in the US, LDOS001 is an open-label Phase I dose escalation trial of L-DOS47, in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous NSCLC.