Helix BioPharma Files IND for a U.S. Phase I Clinical Study of L-DOS47
News Jan 09, 2011
L-DOS47 is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.
L-DOS47 is the Company's first therapeutic immunoconjugate drug candidate under development based upon its 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 (NSCLC).
"This is a significant milestone for Helix. We are seeking approval to commence the much anticipated human clinical testing stage of development for this important new drug candidate," said John Docherty, president of Helix BioPharma Corp. "Having previously completed a pre-IND meeting with the FDA to identify its requirements for this IND filing, we are hoping that the review and approval process will proceed successfully."
The IND review process typically requires 30 days, during which the FDA will decide if an applicant is permitted to proceed with its proposed clinical trial.