Helix BioPharma Corp. Announces Regulatory Approval to Dose Patients in a Phase II Randomized Study of L-DOS47 with Vinorelbine and Cisplatin

(Richmond Hill, Ontario) – Helix BioPharma Corp. (TSX:HBP) (FRANKFURT:HBP) (“Helix” or the “Company”), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, today announced that all necessary regulatory and ethics approvals have been received to dose the first patient in its LDOS003 trial in Ukraine. Regulatory approvals for sites
in Poland are pending. LDOS003 is a Phase IIb, open-label, randomized study in male and female patients aged ≥ 18 years old with metastatic lung adenocarcinoma. This study is designed to determine the possible chemo enhancing properties of L-DOS47. The possibility of combining L-DOS47 with a weakly basic agent like vinorelbine may improve therapeutic outcomes for cancer patients.