Lorus Therapeutics Announces Positive Result In Its Phase II Clinical Study Of LOR-2040 In Acute Myeloid Leukemia (AML)

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Blood / Hematology;  Cancer / Oncology
Article Date: 01 Dec 2009 - 0:00 PDT

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Lorus Therapeutics Inc. (TSX:LOR) ("Lorus" or the "Corporation"), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, announced that its Phase II clinical trial in refractory and relapsed AML with LOR-2040 in combination with cytarabine has been successfully completed to the end-of-stage assessment time point, with favorable results.

The Steering Committee review required at this stage determined that the Phase II efficacy and safety results fulfilled the protocol criteria for continued patient enrolment and are consistent with the promising Phase Ib clinical findings, previously reported by Lorus. It was further agreed that based on the strength of the Phase Ib and II clinical data in a total of 48 patients treated in this indication, expansion to a definitive comparative trial is the most appropriate next step to support registration. On this basis Lorus is proceeding with protocol development for the expanded development program.

The clinical study was conducted at 6 major US centres under the overall direction of Dr. Rebecca Klisovic (Principal Investigator) and Dr. Guido Marcucci at Ohio State University as the protocol co-chairs in collaboration with Lorus. Prominent external reviewers were Dr. Elihu Estey, a leading authority on AML, and Dr. Don Berry, a leader in adaptive statistical trial design.

Twenty-five patients have been treated in the Phase II clinical trial and evaluated alone and together with the results from the prior Phase Ib trial to assess the most appropriate development path for LOR-2040 in this AML population. The Phase II results will be further analyzed for full peer review presentation and publication, and will be disclosed in more detail at that time.

It is notable that the current preliminary evaluation found the response rate to be twice that expected from a risk-matched historical control, and that this is consistent with a further similar analysis of the findings from the prior Phase Ib clinical study. Such risk-based analyses are important to predict the effect in the typically more varied refractory and relapsed AML population expected in a larger comparative trial.

"This is an important milestone for Lorus since it provides an early opportunity to accelerate the clinical development of LOR-2040 in this hard to treat refractory and relapsed AML population", commented Dr. Aiping Young, Lorus' President & CEO. "The comparative clinical trial plan is consistent with the requirements for market registration and with our fastest to approval development strategy."

AML patients who fail or rapidly relapse following initial induction therapy represent a difficult treatment challenge with no currently approved treatment for most patients. The treatment approach to tolerably combine with high dose cytarabine represents a strategy to intensify treatment and benefit without having to combine 3 or 4 drugs, as in other recent treatment approaches, which can be dose limiting for each combination agent.

About LOR-2040

LOR-2040 (formerly GTI-2040) is an antisense drug that specifically targets the R2 component of ribonucleotide reductase, which is required for DNA synthesis and cell proliferation. Through downregulation of R2, LOR-2040 has demonstrated strong antitumor and antimetastatic activity in a variety of tumor types in both in vivo and in vitro models and has been studied in multiple Phase I/II clinical trials. R2 has been described as a malignant determinant that is elevated in a wide range of tumors, which can cooperate with a variety of cellular cancer causing genes known as oncogenes to enhance tumor growth and metastatic potential.

Source
Lorus Therapeutics Inc.

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