ACT announces receipt of Phase II NIH grant to support device development and first-in-human clinical trial for implantable iontophoresis chemotherapy delivery device for direct infusion of gemcitabine into pancreatic adenocarcinoma

Raleigh, NC, August 22nd, 2019 – Advanced Chemotherapy Technologies, Inc. (www.advancedchemotech.com), a combination drug-device company focused on developing iontophoresis drug delivery devices, today announced receipt of a $771,376 grant from the National Cancer Institute of the National Institutes of Health (NIH), to complete implantable iontophoresis chemotherapy delivery device development, and conduct a first-in-human clinical trial.

“We appreciate the NIH’s continued recognition and support of our novel pancreatic cancer device research. This award will accelerate progress on our clinical device build, packaging and sterilization validation of this life saving device, as well as preparation and initiation of our upcoming first-in-human clinical trial” said Tony Voiers President and CEO of ACT.

Every day, an estimated 150 Americans will be diagnosed with pancreatic cancer, and about 120 people will die from the disease. One of the major challenges of pancreatic cancer that contributes to its poor survival rates is the development of resistance to standard chemotherapy. Heterogeneity of the tumor, the dense fibroblastic stroma, and the aggressive biology of the tumor all contribute to chemoresistance. Furthermore, as the aggressive tumor grows into adjacent tissues, it can invade the liver or the stomach, and more often invades local vasculature, rendering the tumor inoperable. As surgical resection is currently the gold standard for treatment, a locally advanced tumor that is non-resectable leaves patients in a state where only palliative care may be offered. ACT is developing a technology that will convert patients with locally advanced non-resectable disease into candidates for surgical resection, by shrinking the tumor away from these vital structures, improving quality of life and extending survival.

The device was developed at the UNC School of Medicine by collaborating scientists Jen Jen Yeh, M.D., Joseph DeSimone, Ph.D. and then M.D./Ph.D. student James Byrne. Yeh is associate professor and vice chair of research in the Department of Surgery. DeSimone is a chancellor’s eminent professor of chemistry at UNC and the William R. Kenan Jr. Distinguished Professor of Chemical Engineering at N.C. State University and of Chemistry at UNC. DeSimone is also co-founder and CEO of Carbon3D. Byrne is now a Clinical Fellow in Radiation Oncology at Massachusetts General Hospital. ACT holds exclusive rights to the patented technology.

About ACT

ACT is a biotechnology company developing implantable devices to infuse chemotherapy drugs directly into affected organs, targeting difficult-to-reach tumors while largely sparing surrounding tissues, organs and blood vessels. Our first device, about the size of a quarter, will be implanted in the pancreas with electrical leads running to the abdomen. The device uses a process called iontophoresis that drives the chemotherapy into the tumor using electrical currents that pass through the drug solution into the tissue. The desmoplastic stroma that is a barrier to systemic chemotherapy because of poor diffusion from the blood vessels can now be opened through a process known as reversible electroporation, permitting the chemotherapy to pass into the tumor. This approach for more precise drug delivery is designed to shrink tumors enough for surgeons to remove them.While not always curative, that improvement could extend those patients’ life expectancy. ACT is headquartered in Raleigh, NC. For more information about ACT, visit www.advancedchemotech.com or email info@advancedchemotech.com.

NIH Award Disclaimer: Research reported in this press release was supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA224460. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.