TAKOMA PARK, Md.--(BUSINESS WIRE)--Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS) and US Medical Innovations, LLC (USMI) announced today that Jerome Canady MD, Chief Science Officer at JCRI-ABTS and a Surgical Oncologist at Holy Cross Hospitals Silver Spring/Germantown, MD will present the results of a Two-year follow up, “Phase I Clinical Trial of Canady Helios Cold Atmospheric Plasma (CHCP) Treatment for Patients with Advanced Stage IV Metastatic and Recurrent Solid Tumors: A Novel Potential 4th Treatment Arm for Cancer” at The Biannual Conference of the Israeli Society of Surgical Oncology (ISSO), May 11-13, 2022 in Haifa, Israel.
Dr. Canady stated, “Metastatic and recurrent Stage IV solid tumors have a poor overall survival (OS) despite the advancement of surgery, chemotherapy, radiation, and immunotherapy. The CHCP Trial was a Phase I, multiple-center, open labelled, prospective controlled trial which enrolled eligible subjects undergoing surgery and intra-operative CHCP treatment. Between March 2020 to April 2021, twenty (20) patients were recruited from Rush University Medical Center Chicago, Illinois and Sheba Medical Center Tel HaShomer, Israel. Patients received intra-operative CHCP treatment at the operative site after the tumor was removed. The primary end point was safety, and the secondary end point was to demonstrate ablation and slowing down tumor growth in cancer patients without damaging surrounding normal biological tissue."
Patients from 26 to 85 years of age (mean age 59) were enrolled in the study. Physiological data was recorded throughout surgery (i.e. blood pressure, pulse, body temperature, End Tidal CO2, and oxygen saturation which demonstrated no significant changes (p > 0.05) during the intra-operative CHCP treatment period). There were no adverse events related to CHCP.
As of May 12, 2022, four patients died of their disease at 3, 4, 8 and 10 months. Kaplan-Meier survival analysis showed that interim OS rate at 26 months was 80.0% (95% confidence interval [CI], 64.3 – 99.6%). Median survival was 14.5 months. Histology of the surgical margins revealed cancer cell death and no damage to normal tissue. Ex vivo culture confirmed reduction of cancer cell growth.
CHCP treatment in combination with surgery for high-risk stage IV solid tumors is safe, induces tumor death and slows down tumor growth in vitro, ex vivo and in cancer patients without damaging non-cancerous tissue. CHCP is potentially a 4th Treatment Arm for Solid Tumor Cancers. (ClinicalTrials.gov identifier: NCT04267575.)
The FDA Phase One Clinical trial was completed April 15, 2021, at Rush University Medical Center (Chicago, IL) and Sheba Medical Center-Tel HaShomer (Ramat Gan, Israel). The Principal Investigators were Professor Steven Gitelis, M.D., and Professor Aviram Nissan, M.D. respectively.
JCRI-ABTS is a state-of-the-art BSL 2 Translational Molecular Research Institute focusing on Plasma Oncotherapeutics (a new cancer treatment modality) using Cold Atmospheric Plasma to investigate and selectively treat cancer without damaging normal tissue.
USMI is a private U.S. biomedical device company and wholly owned subsidiary of US Patent Innovations, LLC. USMI’s focus is developing advanced innovative affordable plasma and robotic electrosurgical devices and striving to develop innovative devices in the field of plasma technology for the eradication of cancer.