Lorus Therapeutics Inc. Receives FDA Clearance Of IND To Initiate LOR-253 Clinical Program In Patients With AML, MDS And Other Blood Cancers
TORONTO, July 28, 2014 /PRNewswire/ - 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.
About Lorus
Lorus is a clinical-stage biotechnology company with a commitment to discovering and developing targeted therapies addressing unmet medical needs in oncology. We aim to develop therapeutics focused on novel cellular targets on the leading edge of cancer research coupled to companion diagnostics to identify the optimal patient population for our products. Our pipeline of cancer drug candidates includes small molecule products and immunotherapies providing additive or synergistic efficacy without leading to overlapping toxicities with existing anti-cancer regimens, facilitating the adoption of combination therapies. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR.
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SOURCE Lorus Therapeutics Inc.