Calyx, a leading technology-enabled provider of Medical Imaging services and IRT/RTSM announced its role in supporting the imaging-based endpoint for the pivotal trial that supported the FDA’s groundbreaking approval of Iovance Biotherapeutic’s AMTAGVI™.
LONDON and BOSTON, May 6, 2024 /PRNewswire/ -- Calyx, a leading technology-enabled provider of Medical Imaging services and IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management) today announced its role in supporting the imaging-based endpoint for the pivotal trial that supported the FDA’s groundbreaking approval of Iovance Biotherapeutic’s AMTAGVI™ (lifileucel). Indicated for the treatment of adult patients with unresectable or metastatic melanoma who have relapsed on other front-line therapy, AMTAGVI is the first cell therapy approved to treat solid tumors, which account for 90% of all cancers.
Calyx Medical Imaging contributed to the design and implementation of the imaging components of the accelerated Phase II clinical trial, enabling 60 investigative sites to capture patient images via CT, MRI, PET, and skin photography in compliance with the protocol. Because image review in cell therapy requires thoughtful and strategic scientific implementation, Calyx’s oncology imaging experts designed an image review methodology that enabled uniform and consistent evaluation by Calyx’s independent readers.
“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,” said David Herron, CEO of Calyx Medical Imaging. “We are honored to have played a role in this important development program and look forward to continuing our collaboration with the Iovance team.”
For more information on Calyx’s experience in oncology trial imaging, visit Oncology Imaging Services| Calyx.
About Calyx
Calyx is a leading global technology-enabled service provider for Medical Imaging and IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management) for drug developers and the global clinical research community. Calyx’s market-leading service, scientific knowledge, expertise, and technology offering help speed up the delivery of life-saving treatments to millions of patients around the world by accelerating and improving clinical trial outcomes.
With operations in six countries, the company provides 24/7 services to most of the world’s leading pharma and biotech companies.
For more information go to Calyx.ai and follow us on LinkedIn, Twitter, and Facebook.
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