Helix BioPharma Corp., has announced that it has received approval for its investigational new drug ("IND") application from the United States Food and Drug Administration ("FDA") to perform its planned U.S. Phase I clinical safety and tolerability study of its lung cancer drug candidate L-DOS47.
L-DOS47 is the Company's first therapeutic immunoconjugate drug candidate under development based upon its novel DOS47 platform 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 ("NSCLC").
The FDA has completed its review of the IND and concluded that it is acceptable for Helix to proceed with the study, contingent on Helix providing an amended version of the clinical protocol beforehand, reflecting several minor changes that FDA stipulated during the course of the IND review.
"Receiving FDA approval to perform this study is a major milestone for Helix," said John Docherty, president of Helix BioPharma Corp. "We are very pleased that in granting this approval the FDA considers that L-DOS47 merits entry into the human clinical stage of its development."
The Company will now proceed with its remaining pre-study logistical preparations, including preparation and filing with the FDA of the required clinical protocol amendment, with a view to commencing clinical site initiation and patient recruitment activities late spring to early summer of this year.