TAKOMA PARK, Md.--(BUSINESS WIRE)--The Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI) and US Medical Innovations, LLC (USMI) announced today that the full results from its successful FDA Phase 1 Clinical Trial has just been published in the scientific journal “Cancers”, a MDPI Publication.
Despite advancements in surgery, chemotherapy, immunotherapy, and targeted therapies, local regional recurrence (LRR) of malignant solid tumors following surgical removal remains a significant issue. It is estimated that 65% of solid tumor resections result in residual microscopic tumor cells at the surgical margin, which contributes to LRR and poor survival rates.
The results collected from the clinical trial combined with the JCRI in-vitro and clinical research data generated over the last 10 years, demonstrated that the Canady Helios™ Cold Plasma (CHCP) combined with complete surgical resection of the tumor, causes cancer cell death at the surgical margin, without harming non-cancerous tissue. The recent trial reveals that treating the surgical margin following a tumorectomy significantly reduced local recurrence and increased overall survival. CHCP opens a new and promising treatment for addressing the challenges of eradicating microscopic residual cancer cells following surgical tumor resection.
Jerome Canady, M.D., FACS, CEO stated, “We are very pleased to have our results published in the peer reviewed journal 'Cancers'. The results showed R0 (resected tumor with clean margins) patients and R0-MPM (microscopic positive margins) patients, had a 69% and 100% overall response rate (no recurrence from the time of CHCP treatment to LRR in R0 resected patients) respectively. Local recurrence-free survival rate was 80% over 26 months for R0-MPM patients. To date, there are no clinical treatments that ensure the complete eradication of microscopic tumor cells at the surgical margin without damaging the surrounding healthy tissue. USMI is the first to achieve these promising results and look forward to starting multi-site FDA Phase 2 Clinical Trials later this year.”
Dr. Taisen Zhuang, Chief Technology Officer discusses the novel technology, "The Canady Helios™ Cold Plasma Generator applies a non-contact, non-thermal (26-30°C) plasma beam to the target zone called the Plasma Treatment Electrical Field™ (PTEF™). The PTEF, a bioelectric electromagnetic field, creates a phenomenon in the cancer cells called Irreversible Electroporation (openings in the cancer cell’s membrane). The PTEF also contains electrically charged particles, reactive oxygen species (ROS) and reactive nitrogen species (RNS) that permeate the cell’s membrane leading to apoptosis (cell death).”
Dr. Saravana Murthy, VP of Research at JCRI, explains the patented translational molecular effect, "During the growth phase of cells, the messenger molecules (mRNAs) responsible for producing Histone Proteins are closely controlled to maintain cell division, stability, and survival. The CHCP treatment takes advantage of this regulation to target rapidly dividing cancer cells without harming normal cells, as cancer cells tend to undergo this growth phase more often. By affecting the Histone RNA, CHCP causes cell death in microscopic cancerous cells at the surgical margins while sparing normal healthy cells."
Dr Canady continued, “We would like to thank the patients, their families, previous compassionate-use patients, principal investigators Professor Steven Gitelis, M.D., Professor Aviram Nissan, M.D. as well as the surgical teams at Rush University Medical Center in Chicago, IL, USA, and Sheba Medical Center in Tel HaShomer, Israel who performed these advanced high-risk surgical procedures.”
For more information about the CHCP clinical trial and USMI's innovative medical technologies, please visit ClinicalTrials.gov identifier: NCT04267575.
The Paper can be found on the MDPI website at www.mdpi.com
About JCRI-ABTS
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.
About US Medical Innovations
US Medical Innovations, LLC (USMI), based out of Takoma Park, MD, is a privately held FDA registered life science and biomedical device company. USMI is dedicated to expanding the boundaries of plasma medicine by pioneering new technologies for the development of state-of-the-art medical devices that advance patient outcomes and improve human lives.
