Lorus Therapeutics Inc. (TSX: LOR) today announced that the Food and Drug Administration (FDA) completed its review and cleared the company's Investigational New Drug (IND) application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), lymphomas and multiple myeloma.
Clearance of the IND allows Lorus to initiate a Phase 1b, multi-center, open-label, clinical study of LOR-253 in patients with relapsed or refractory hematologic malignancies. The Phase 1b trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamic responses and efficacy of LOR-253 as a single agent. The trial is expected to enroll 45-60 patients as part of a dose-escalation program and two separate disease-specific single-agent expansion cohorts.
LOR-253 is the only clinical-stage compound known to induce the KLF4 gene. The suppression of KLF4 has been reported as a key transforming event in AML and high-risk MDS, and Lorus believes that LOR-253 may represent a targeted therapeutic solution for a very difficult-to-treat cancer.