TIGeR-PaC Phase III trial reaches first patient in Europe, with overall enrollment exceeding 20 percent worldwide
Los Altos, Calif., Boston, Durham, N.C.– Jan. 13, 2020 – RenovoRx, Inc., an innovator in targeted cancer therapy, and Parexel Biotech, a division of Parexel, one of the world’s leading global clinical research organizations (CROs) focused on accelerating the development and delivery of innovative new therapies to improve world health, today announced the TIGeR-PaC Phase III clinical trial of Trans-Arterial Micro-Perfusion (TAMPTM) has reached its first patient enrolled in Europe. Overall trial enrollment is on schedule and is exceeding 20 percent worldwide.
The trial’s goal is to determine whether delivering gemcitabine chemotherapy directly to the tumor intra-arterially via a proprietary FDA cleared device, RenovoCath, can reduce the chance of cancer spreading and extend survival while improving quality of life for pancreatic cancer patients. The study, which currently has over 30 sites active or in process in Belgium and the United States, is expected to ultimately involve approximately 200 participants in 40 sites across the US and Europe. Parexel Biotech is assisting with the management of the European arm of the TIGeR-PaC Trial, which began in March 2019.
“The number of pancreatic cancer cases is increasing globally. Although advances in cancer treatments continue to grow, there is still a great need for more treatment options for patients with pancreatic cancer,” said Ramtin Agah, MD, Founder and Chief Medical Officer, RenovoRx.
Shaun Bagai, Chief Executive Officer, RenovoRx, added, “We partnered with Parexel Biotech to test and refine this novel approach because of their expertise in oncology trials. We’re pleased with the joint progress that we are making in improving outcomes for pancreatic cancer patients.”
Parexel Biotech provides tailored product development services to help biotech companies meet clinical development timelines, optimize product and pipeline value and navigate complex regulatory and reimbursement landscapes. The team provides life science companies strategic guidance based on years of industry experience combined with clinical and commercial services delivered through lean operational structures that are personalized to their needs and therapeutic specialty.
“In Phase II and III clinical trials, challenges in site activation and patient recruitment can lead to significant long-term delays,” said Sy Pretorius, MD, Executive Vice President and Chief Medical & Scientific Officer, Parexel. “Our biotech team understands the importance of meeting these milestones, and is committed to innovative, patient-centric approaches to optimize study start-up and accelerate market access to treatments for patients who need them most.”
The randomized TIGeR-PaC trial is enrolling newly diagnosed, locally-advanced pancreatic cancer patients in the United States and Europe. To learn more, visit https://renovorx.com/clinical-trial/.
Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.
Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.
About RenovoRx, Inc.
RenovoRx, headquartered in Silicon Valley, California, is developing innovative solutions for targeted delivery of fluids, including diagnostic and therapeutic agents such as chemotherapy, to specific sites in the body. Delivering these concentrated agents through the Trans-Arterial Micro-Perfusion (TAMP) procedure with RenovoCath safely and without transmission to non-targeted areas, is the focus of RenovoRx technology. Learn more by visiting the RenovoRx website or following us on Facebook, LinkedIn and Twitter.
RenovoRx and RenovoCath are registered trademarks of RenovoRx, Inc.