Coralville-based Viewpoint Molecular Targeting Inc., a radiopharmaceutical company developing precision alpha-particle oncology therapeutics and complementary diagnostic imaging agents, has announced it has launched patient enrollment and screening in a Phase 1 imaging study evaluating the company’s VMT01 program for the treatment of metastatic melanoma.
Melanoma is a cancer of the skin and the most aggressive form of skin cancer. While a disease that is identified early (when confined to the outer layers of the skin) can be cured by surgery, melanoma that migrates to distant sites in the body (metastatic melanoma) is difficult to treat, company officials said in a news release. Despite the introduction of new treatments for metastatic melanoma, according to the American Cancer Society, the five-year survival is approximately 25%.
The current VMT01 Phase 1 imaging study is being conducted at the Mayo Clinic in Rochester, Minn., and a future therapy study is planned, officials said. Provisional results for the imaging study are targeted for the fourth quarter of 2021. Following the results of the imaging trial, the company plans to initiate a multisite Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.
“The start of the VMT01 imaging study represents a significant milestone for the company,” said Frances L. Johnson, MD, chief executive officer and co-founder of Viewpoint Molecular Targeting. “The study tests Viewpoint’s investigational imaging agents in subjects with advanced melanoma to accelerate therapeutic drug development and enable image-guided treatment. We are pleased to be working alongside Mayo Clinic to advance this novel theranostic approach to radiopharmaceutical therapy against metastatic melanoma. Based on the extremely encouraging preclinical data seen to date, we believe that our targeted alpha-particle therapies have the potential to significantly enhance treatment responses in metastatic melanoma.”
The Phase 1 first-in-human, crossover design study of Positron Emission Tomography (PET) and Single-Photon Emission Computerized Tomography (SPECT) scanning will include approximately 10 patients with Stage III/IV unresectable melanoma. The study is focusing on safety and biodistribution, with secondary targets of molecular target validation and image quality.
Viewpoint’s VMT01 program is intended to address an unmet clinical need with the use of a new imaging agent to guide Viewpoint’s radiopharmaceutical therapy against metastatic melanoma, often referred to as “theranostics.” Using information guided by the low-risk medical imaging scan, a treatment plan utilizing the VMT01 program is designed to deliver the power of alpha-particle radiation specifically to melanoma tumors, while minimizing risk to unaffected organs and tissues.
