Helix BioPharma Files European Clinical Trial Application for a Phase I/II Study of its Lung Cancer Drug Candidate L-DOS47

Helix BioPharma Corp., a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer, has announced that it has filed a clinical trial application with the Central Register of Clinical Trials at the Polish Ministry of Health seeking approval to perform its planned Phase I/II clinical safety, tolerability and preliminary efficacy study of its lung cancer drug candidate L-DOS47.

L-DOS47 is Helix's first therapeutic immunoconjugate drug candidate under development based upon the Company's novel DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic, non-small cell lung cancer.

"The proposed Phase I/II clinical study will employ a sophisticated design, intended to allow Helix to study the effects of L-DOS47 both as a stand-alone therapy and in combination chemotherapy or radiation therapy regimens, within specific parameters," said John Docherty, President of Helix BioPharma Corp.

Docherty continued: "Based on the local alkalizing properties of L-DOS47, we believe it may function synergistically with other cancer therapies that are known to be compromised by tumor acidity. We are very much looking forward to the prospect of beginning to assess the synergistic capabilities of L-DOS47 and its stand-alone effects in NSCLC patients in this study, pending regulatory approvals."

The CTA review process in Poland typically requires 60 days, during which the reviewers will decide if an applicant is permitted to proceed with its proposed clinical trial. Additional information may be requested from the applicant, which could extend the review period.