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 supported Iovance in the trial that
led to the approval of AMTAGVI™, the first cell therapy to treat
solid tumors
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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SOURCE Calyx