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Strategia begins Phase I/IIa trial of anti-cancer agent to treat advanced hematologic malignancies

Strategia Therapeutics has initiated a Phase I/IIa clinical trial of anti-cancer agent E6201 to treat patients with advanced hematologic malignancies.

The anti-cancer agent is designed to treat relapsed or refractory acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

The trial is being conducted at the University of Texas MD Anderson Cancer Center with Gautam Borthakur as the principal investigator.

Discovered by Eisai, E6201is a dual-inhibitor of FMS-like tyrosine kinase 3 (FLT-3) and mitogen-activated protein (enzyme) kinase (MEK).

Strategia head of Drug Development Dr Linda Paradiso said: "We have in-licensed E6201 from Eisai Co., Ltd. and they have been an excellent collaborative partner."

Activation of FLT3 is observed in patients with AML carrying either internal tandem duplication (ITD) or point (D835) mutations in the FLT3 gene, and E6201 has showed activity against both mutations.

Borthakur noted: "This drug may be important for patients with advanced hematologic malignancies who have failed conventional therapeutics, including single-agent FLT3 inhibitors.

"By inhibition of both the FLT3 and MEK pathways we hope to provide more durable clinical benefit than through inhibition of one pathway alone.

"This study will build on our preclinical evidence, and further this important clinical research at our institution."

The company said that Ras/Raf signaling pathway signals through the downstream signal transducers MEK1 and extracellular signal-related kinases (ERK) and activation of this pathway is seen in AML cells of patients failing FLT3 inhibitor therapy.

According to the preclinical studies conducted by Dr Borthakur indicate inhibition of both pathways is important to durable responses.