FDA clears Lorus' LOR-253 IND application for treatment of hematologic malignancies

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.


Lorus Therapeutics Inc.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
GLP-1 drugs found to lower cancer risk in diabetes patients