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Helix files clinical trial application for L-DOS47 in Canada to treat solid tumors

Canada-based biopharmaceutical firm Helix BioPharma has submitted a clinical trial application (CTA) with Health Canada for approval to start a Phase I clinical trial with L-DOS47, the company's first immunoconjugate-based drug candidate.

The trial is a Phase I, open label, dose escalation study of immunoconjugate L-DOS47 in combination with vinorelbine in patients with metastatic or advanced solid tumors.

Helix president and chief executive officer Robert Verhagen said acidic pH microenvironment may limit the effectiveness of weakly basic cytotoxic drugs employed in the treatment of solid tumors.

"The possibility of combining L-DOS47 with a weakly basic agent like vinorelbine may improve therapeutic outcomes for cancer patients," Verhagen said.

L-DOS47 is being developed based upon the company’s new DOS47 technology, which is designed to use an new approach to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.

Currently, L-DOS47 is being clinically assessed as a treatment for certain patients with non-small cell lung cancer.

At present, the company has a European Phase I/II L-DOS47 monotherapy clinical trial ongoing in Poland and has recently received approval from the US Food and Drug administration for a Phase I clinical trial of L-DOS47 in combination with pemetrexed/carboplatin.