28 November 2018 - - US-based oncology research and development company 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 company said.

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 US 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 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.

Spirita Oncology is an integrated oncology research and development company with experience in developing, managing and optimising global pharmaceutical drug development programs from late discovery, translational research and clinical development through market authorization and post-marketing life-cycle management.