Canadian biopharmaceutical firm Helix BioPharma has initiated patient enrolment for the tenth dose level group in its ongoing Phase I/II clinical trial (LDOS002) of L-DOS47 in Poland to treat certain patients with non-small cell lung cancer (NSCLC).
The company is developing L-DOS47, its first immunoconjugate-based drug candidate, based on its new DOS47 technology that uses a new approach to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.
The open-label Phase I/II 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.
In the first patient group of the trial, patients were given a dose of 0.12 micrograms (µg) of L-DOS47/kg of patient body weight.
Patients participating in the tenth group of the trial will receive the next dose level of 2.45µg of L-DOS47/kg of their body weight.
Helix president and chief executive officer Robert Verhagen said: "We continue to be pleased with the safety of our lead candidate as we continue planning for additional trials in North America to complement this important study.
"We continue to review the data from the first eight dosing cohorts and we expect to provide an update by the end of September."
In the US, the company has received approval to conduct the open-label Phase I dose escalation trial (LDOS001) of L-DOS47.
Currently, L-DOS47 is being evaluated in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous NSCLC.