Helix BioPharma has started patient enrolment in the second dosing cohort of its US-based Phase I trial (LDOS001) to evaluate its first immunoconjugate-based drug candidate, L-DOS47.
L-DOS47 is being tested in combination with pemetrexed / carboplatin as a treatment for certain patients with non-small cell lung cancer (NSCLC).
US-based Helix is a biopharmaceutical firm that develops new drug candidates for the prevention and treatment of cancer.
The Safety Review Committee (SRC) recommended that the company start enroling a new patients, after reviewing safety data from the trial’s first dosing cohort.
Patients enroled in the second cohort will receive the next L-DOS47 dose level, which is 0.78 micrograms of L-DOS47 per kg of patient body weight.
L-DOS47 is being developed based on the company’s new DOS47 platform technology, which is designed to modify the microenvironmental conditions of, and eventually eliminate, cancer cells.
The Phase I LDOS001 trial is being carried out in the US at three centres: The University of Texas, M.D. Anderson Cancer Centre, Penn State Milton S. Hershey Medical Center; and University Hospitals Case Medical Center.
The trial’s primary objective is to determine the safety and tolerability of L-DOS47 in combination treatment with pemetrexed / carboplatin.
LDOS002 is an open-label Phase I / II trial being conducted in Poland to evaluate the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47.
The treatment is initially being tested as a monotherapy, in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb / IV NSCLC.