Helix BioPharma receives FDA approval for lung cancer drug US Phase I trial
Helix BioPharma, a US based biopharmaceutical company focused on cancer therapy, has received the US Food and Drug Administration’s (FDA) approval to perform its planned US Phase I clinical safety and tolerability study for its investigational new lung cancer drug candidate L-DOS47.
L-DOS47, Helix's first therapeutic immunoconjugate drug candidate under development based upon its novel DOS47 platform technology, is designed to modify the microenvironmental conditions of cancer cells so that they get destroyed.
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).
Helix BioPharma president John Docherty said receiving FDA approval to perform this study was a major milestone for the company.
The company will now proceed with its remaining pre-study logistical preparations with a view to commence clinical site initiation, and patient recruitment activities late spring to early summer this year.
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