Helix BioPharma has secured all necessary regulatory and ethics approvals to dose the first patient in its LDOS003 trial, due to be held in Ukraine.
LDOS003 is a Phase IIb, open-label, randomised study that aims to determine the possible chemo-enhancing properties of L-DOS47 inpatients with metastatic lung adenocarcinoma.
The trial is designed to enrol male and female patients less than 18 years old.
The first part of the trial is a dose escalation stage where patients will receive eight doses of L-DOS47 over four cycles.
On the first and eigth days of each cycle, L-DOS47 will be administered 24 hours before vinorelbine/cisplatin as an intravenous (IV) infusion.
Following the achievement of the maximum tolerated dose of L-DOS47 as an adjunct to vinorelbine/cisplatin, the trial will enrol patients for the second part that includes a randomised treatment period.
Patients in this part will be randomly assigned to receive L-DOS47 in combination with vinorelbine/cisplatin or vinorelbine/cisplatin alone.
Enrolment for the LDOS003 trial is expected to begin next month.
Helix BioPharma CEO Heman Chao said: “L-DOS47 has been postulated to reduce tumour acidity and therefore enhances the effect of chemotherapeutics such as vinorelbine.
“LDOS003 is an important trial to explore this potential benefit to patients. Strategically this is an important development for Helix as we are looking to establish L-DOS47 as a unique combination with chemotherapeutics in cancer treatment.”
Helix is awaiting regulatory approvals to conduct the LDOS003 trial in sites across Poland.
In addition, the company is enrolling patients for its LDOS001 trial, a dose escalation study of L-DOS47 with pemetrexed and carboplatin for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer.