Lorus says results of GTI-2040 trial demonstrate strong response in myeloid leukemia patients

By E. Janene Geiss

Philadelphia, Dec. 12 - Lorus Therapeutics Inc. said Monday that results of the clinical trial of GTI-2040 in acute myeloid leukemia demonstrated complete responses in 44% of patients under 60.

The trial combined GTI-2040 with cytarabine in patients with recurrent or refractory acute myeloid leukemia. These patients have few remaining treatment options and without novel therapies are candidates for bone marrow transplants, according to a company news release.

Patients in this trial had either failed to respond to prior therapy or had rapidly relapsed. Such patients usually have a very low expectation of complete response of approximately 10% to 20% on salvage therapies such as high-dose cytarabine, officials said.

Notably, officials said complete responses in the clinical trial directly correlated with down regulation of the R2 intracellular target of GTI-2040, and this was statistically significant with a P value less than 0.05. Down regulation of the R2 target demonstrates drug specificity and provides strong evidence for an antisense mechanism of action.

It was further demonstrated that intracellular levels of GTI-2040 were achieved in the target tissue, accumulating to higher levels in leukemic CD34+ blasts in the bone marrow, which correlated with more target down regulation, officials said.

The study showed that GTI-2040 was well-tolerated when combined with high-dose cytarabine. Toxicities for the combination were comparable to those expected for cytarabine alone and were non dose-limiting, officials said.

"In addition to confirming the feasibility and safety of combining GTI-2040 with high-dose cytarabine without compromising tolerability, this study has provided important evidence for clinical activity associated with target down regulation in an important group of patients 60 years of age or younger," principal investigator Guido Marcucci said in the release. "This is the kind of evidence we strive for to support further development of a targeted compound."

This study is being sponsored by the Cancer Therapy Evaluation Program of the National Cancer Institute under a Clinical Trials Agreement between the program and Lorus.

The program also is sponsoring five other clinical trials with GTI-2040 in different cancer indications under the Clinical Trials Agreement.

The data were presented at the American Society of Hematology annual meeting in Atlanta.

Lorus is a Toronto, Ont., biopharmaceutical company specializing in the development and commercialization of pharmaceutical products and technologies for the management of cancer.

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