Spirita Oncology, LLC Initiates a Phase 1 Clinical Trial of the Anti-Cancer Agent E6201 in Patients with Central Nervous System Metastases from BRAF+ or MEK-Mutated Metastatic Melanoma
Spirita Oncology, LLC, has initiated a Phase 1 clinical trial of anti-cancer agent E6201 in patients with central nervous system metastases from BRAF- or MEK-mutated metastatic melanoma. The trial is being carried out at the University of Arizona Cancer Center with Hani Babiker, M.D., as Principal Investigator.
There are approximately 47,000 new cases of metastatic melanoma in the U.S. each year, with approximately 10,000 deaths. More than 15,000 of these patients develop brain metastases. The median overall survival for patients with brain metastases is 4 months. Approximately 50% of patients harbor BRAF- or MEK-mutated melanoma, with limited treatment options are available. Targeted therapies and immune checkpoint inhibitors have improved overall survival for metastatic melanoma patients with brain metastases. However, responses are usually of short duration and new agents that effectively penetrate the blood brain barrier are needed.
E6201 is an ATP-competitive MEK1 inhibitor that has demonstrated preclinical activity in BRAF V600E mutant melanoma cell lines. E6201 has shown excellent brain distribution characteristics and minimal CNS efflux by transporters at the blood brain barrier. A Phase 1 trial (NCT00794781) evaluating E6201 in 55 patients with advanced solid tumors demonstrated activity in metastatic melanoma patients, including two patients with brain metastases, one of whom maintains an exceptional ongoing durable response lasting for almost 9 years.
The University of Arizona Cancer Center is one of only 45 National Cancer Institute designated Comprehensive Cancer Centers in the nation. That designation is reserved for centers focusing on patient care as well as basic and clinical research, prevention, education, outreach and training. The Cancer Center is a leader in research on women’s cancers (breast, ovarian), men’s cancers (prostate), gastrointestinal cancers (colon, pancreas and liver), lymphoma and skin cancers and is home to one of the largest Cancer Prevention and Control Programs.
“We participated in the E6201 Phase 1 trial in which exceptional responses were seen in patients with metastatic melanoma brain metastases, and we are very excited to be collaborating with Spirita Oncology on this important clinical trial for patients who harbor BRAF- or MEK-mutated metastatic melanoma with brain metastases,” said Hani Babiker, M.D. “We look forward to furthering this important clinical research at our institution.”
“E6201 is a potent MEK1 inhibitor. By utilizing a targeted drug against BRAF- or MEK-mutated melanoma CNS metastases with excellent brain penetration and retention, we hope to provide a more effective therapeutic, alone and in combination, than achieved with the currently available targeted agents and immunotherapies,” said Dr. Linda Paradiso, Chief Development Officer for Spirita Oncology. “We in-licensed E6201 from Eisai Pharmaceuticals and they have been an excellent collaborative partner. Both companies are fully committed to deliver breakthrough therapies using innovative approaches to achieve industry benchmark-beating timelines, quality, and financial investments for important novel anti-cancer agents”.
About Spirita Oncology, LLC:
Spirita Oncology is an integrated oncology research and development company with experience in developing, managing and optimizing global pharmaceutical drug development programs from late discovery, translational research and clinical development through market authorization and post-marketing life-cycle management.
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