Helix BioPharma Corp. (TSX, NYSE Amex, FSE: HBP) today announced that it has completed its definitive GLP, rodent and primate, repeat-dose toxicology studies with L-DOS47. These studies demonstrated a good safety profile in an expanded number of rodent and primate test animals, building upon Helix's positive findings from its preliminary non-GLP toxicology studies.
The Company plans to conduct a Phase I study in the U.S. in patients with refractory solid tumors and a Phase I/II, multi-arm safety and preliminary efficacy study in patients with stage III/IV non-small cell lung cancer in Poland. It intends to use the findings from its GLP toxicology studies to complete the necessary protocol designs and other supportive documentation, as final steps in preparing its U.S. Phase I IND and its Polish Phase I/II CTA dossiers. As a result of some delays in completing its GLP toxicology studies, Helix now expects these IND/CTA submissions to be made in its second rather than its first quarter of fiscal 2011.
"We are very pleased to reach this important clinic-enabling milestone in our L-DOS47 development program," said John Docherty, Helix president and COO. "Having completed these studies, Helix believes it now has a sufficient preclinical pharmacology and toxicology database to support human clinical testing with this important new drug candidate. Helix is committed to completing these submissions as soon as possible, as it is no longer waiting for any further preclinical study findings before doing so."
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