Calyx Medical Imaging Aids Revolutionary Melanoma Treatment Approval

May 6, 2024 -- Calyx, a prominent provider of Medical Imaging services and IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management), has announced its significant role in the pivotal trial that led to the FDA's groundbreaking approval of Iovance Biotherapeutic's AMTAGVI™. This new treatment is designed for adult patients with unresectable or metastatic melanoma who have not responded to other frontline therapies. AMTAGVI™ is notable as the first cell therapy approved for the treatment of solid tumors, which comprise 90% of all cancers.

Calyx was instrumental in supporting Iovance during the trial phase that resulted in the approval of AMTAGVI™. The company's Medical Imaging division played a crucial role in designing and implementing the imaging components for the accelerated Phase II clinical trial. This effort enabled 60 investigative sites to capture patient images using CT, MRI, PET, and skin photography, all in strict adherence to the trial protocol. Given the complexity of image review in cell therapy, which necessitates careful scientific implementation, the oncology imaging experts at Calyx developed an image review methodology. This methodology enabled consistent and uniform evaluation by the company's independent readers.

David Herron, CEO of Calyx Medical Imaging, expressed the significance of Iovance's work: "The work that Iovance is doing is extremely important, not only to melanoma patients and their loved ones but also to the broader oncology research community. We are honored to have played a role in this important development program and look forward to continuing our collaboration with the Iovance team."

About Calyx

Calyx is recognized globally as a key technology-enabled service provider specializing in Medical Imaging and IRT/RTSM for drug developers and the international clinical research community. The company's cutting-edge services, scientific expertise, and technological advancements are designed to accelerate and enhance the outcomes of clinical trials, thereby expediting the delivery of life-saving treatments to millions of patients worldwide.

Operating in six countries, Calyx offers around-the-clock services to many of the world's leading pharmaceutical and biotech companies. The company’s comprehensive service offering and scientific acumen have established it as a leader in the field, significantly contributing to the progress of global clinical research and drug development.

In summary, Calyx's involvement was pivotal in the trial that led to the FDA's approval of AMTAGVI™, marking a significant milestone in the treatment of melanoma and potentially other solid tumors. As the first cell therapy approved for solid tumors, AMTAGVI™ represents a major advancement in oncology, offering new hope to patients who have exhausted other treatment options. Calyx's expertise in medical imaging and clinical trial support was crucial in achieving this breakthrough, exemplifying the company's role in advancing medical research and treatment.

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