The Food and Drug Administration (FDA) has completed its review and cleared the Lorus Therapeutics Inc.'s Investigational New Drug (IND) application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukaemia (AML), high-risk myelodysplastic syndromes (MDS), lymphomas and multiple myeloma.

Clearance of the IND allows Lorus to initiate a phase 1b, multi-centre, 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 programme 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.

Lorus is a clinical-stage biotechnology company with a commitment to discovering and developing targeted therapies addressing unmet medical needs in oncology.