On June 15, 2023 The Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS) and US Medical Innovations, LLC (USMI) reported significant positive results from the first FDA Phase I IDE (#G190165) clinical trial for cancer using Canady Helios TM Cold Plasma (CHCP) combined with standard surgical resections at the 2023 American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (May 31-June 4, 2023) (Press release, JCRI-ABTS, JUN 15, 2023, View Source [SID1234632765]). Safety was the primary endpoint; secondary endpoints were the effect on local regional recurrence (LRR), cancer cell death, preservation of surrounding healthy tissue, and patient survival. (ClinicalTrials.gov identifier: NCT04267575)
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Cancer remains a significant global health challenge, with over 1.9 million new cases and 608,570 cancer-related fatalities in the United States in 2021. Advances in chemotherapy, radiation, surgery, immunotherapy, and molecular targeted therapy regimes have improved survival, but solid tumor resections still have a risk of LRR and a poor five-year survival rate. Surgery is the primary treatment for most solid tumors, but complete removal of cancerous tissue (R0), microscopic tumor cells (R1) or visible tumor (R2) is challenging which can lead to LRR in 5% to 65% of cases.
USMI’s Canady Helios Cold Plasma (CHCP) system, a non-thermal (26-30°C) and non-contact Cold Atmospheric Plasma (CAP) jet, offers a promising solution. The three-dimensional bioelectric Plasma Treated Electromagnetic Field (PTEF) created by CHCP causes a biophysical phenomenon known as Irreversible Electroporation (IRE), that increases cancer cell membrane permeability to CAP species such as Reactive Oxygen Species (ROS) and Reactive Nitrogen Species (RNS). This process results in cancer cell death while sparing the noncancerous tissue. The JCRI-ABTS research laboratory discovered and patented the process by which CHCP-treated cancer cells undergo histone mRNA oxidation and degradation, leading to the activation of DNA damage response genes and cell death (link)1. Standard CHCP treatment dosages for 32 cancer cell lines including breast, sarcoma, glioblastoma, melanoma, ovarian, prostate, colorectal, and lung cancers. have been developed in the JCRI-ABTS laboratory.
The Clinical Trial was a multi-center, open-label, prospective, and controlled study conducted between March 2020 – April 2021 at Rush University Medical Center (RUMC) in Chicago, IL, USA, and Sheba Medical Center (SMC) in Tel HaShomer, Israel. Molecular biological studies were performed at JCRI-ABTS. Twenty patients ranging from 26-85 years of age undergoing surgery for advanced stage 4 or recurrent solid tumors were enrolled. Patients with preoperative treatments such as neoadjuvant chemotherapy, immunotherapy, radiation, and previous surgery were eligible.
Characteristics of Patients
Characteristic
No.
%
No. of Patients
20
Sheba Medical Center
5
25
Rush Medical Center
15
75
Age
Median
59.5
Range
26-85
Female
10
50
Male
10
50
Ethnicity
White
18
90
African American
1
5
Other
1
5
ECOG1 Performance Status
<2
20
100
Cancer types (all metastatic)
Adenoid Cystic Carcinoma
1
5
Anal
1
5
Angiosarcoma
1
5
Breast
1
5
Cholangiocarcinoma
1
5
Chordoma
1
5
Colon
2
10
Melanoma
1
5
Mesothelioma
1
5
Non-Small Cell Lung*
3
15
Ovarian
1
5
Renal
1
5
Sarcoma**
4
20
Squamous Cell Carcinoma
1
5
1 ECOG – Eastern Cooperative Oncology Group
* Two Carcinomas and 1 Adenocarcinoma
** Desmoplastic small round cell sarcoma, myxofibrosarcoma, pleomorphic sarcoma, and pleomorphic spindle cell sarcoma
Overall response rates (ORR) at 26 months for R0 and R0 with Microscopic Positive Margins (R0-MPM) patients were 69% (95% CI, 19-40%) and 100% (95% CI, 100 – 100.0%), respectively. ORR was defined as no recurrence from the time of CHCP treatment to LRR in R0 resected patients. ORR was evaluated by postoperative T2 weighted MRI, PET or CT scans.
Overall Survival (OS) for R0 (n=7), R0-MPM (n=5), R1 (n=6), and R2 (n=2) patients at 28 months were 86%, 40%, 67%, and 0%, respectively. The cumulative OS rate was 24% at 31 months (n=20, 95% CI, 5.3 – 100.0). OS was defined as the duration from the intraoperative CHCP treatment to death.
CHCP treatment did not affect intraoperative physiological vital signs (blood pressure, pulse, O2 saturation, end tidal CO2, and temperature, p > 0.05). No systemic toxicities or device-related adverse events were observed. Overall, CHCP treatment combined with surgery is safe, selective towards microscopic tumor cells at the margin, and demonstrates exceptionally low LRR in R0 and R0-MPM patients.
Time
(Months)
Number at
Risk
Deaths
Survival Rate
Standard
Error
Lower 95% CI
Upper 95% CI
0
20
0
100%
0.00
1.00
1.00
5
18
2
90%
0.07
0.78
1.00
10
16
3
75%
0.10
0.58
0.97
15
15
0
75%
0.10
0.58
0.97
20
15
1
70%
0.10
0.53
0.93
25
8
0
70%
0.10
0.53
0.93
30
3
2
48%
0.15
0.26
0.88
31
2
1
24%
0.19
0.05
1.00
OS analysis for CAP-treated patients (n=20). P=0.0058.
Jerome Canady, MD., FACS., Surgical Oncologist, and CEO stated, "One inherent problem of excising any solid tumor tissue is ensuring complete surgical removal of the tumor and the microscopic tumor cells at the margins, which reduces the chance of local regional recurrence. To date, there are no treatments on the market that ensure the complete eradication of microscopic tumor cells at the surgical margin without damaging the surrounding healthy tissue. CHCP treatment with surgery shows immense promise in controlling local recurrence and improving survival in patients with advanced solid tumors. The treatment selectively kills microscopic tumor cells at the surgical margin. CHCP treatment is non-invasive, administered for 5 – 7 minutes intraoperatively, and has no side effects. It seamlessly integrates into existing treatment protocols without disruption."
Professor of Surgery Giacomo Basadonna MD., Ph.D., FACS Department of Surgery University of Massachusetts School of Medicine Worcester and co-author of the study stated, "The results of this clinical investigation are truly remarkable and offer renewed hope to cancer patients with advanced disease. The data from the trial combined with the amount of mechanistic information collected over many years, clearly show that Canady Helios Cold Plasma treatment causes cancer cells to die within a brief period leaving normal tissue untouched. The current trial shows that treating the surrounding tissue following tumorectomy prevents local recurrence and increases overall survival. Although this trial was conducted in patients with severe disease for regulatory reasons, the results open the door to treating the tumor bed and the adjacent tissue following removal of primary malignancies and truly guarantee cancer-free surgical margins."
These groundbreaking results highlight the safety, selectivity, and significant reduction of local regional recurrence achieved through the combination of CHCP treatment and surgery. USMI’s Canady Helios Cold Plasma system opens a new and promising avenue for addressing the challenges of eradicating microscopic residual cancer cells following surgical tumor resection without damaging surrounding healthy tissue.
JCRI-ABTS and USMI thank the participating patients and their families, prior compassionate use patients, surgical teams performing these advanced surgical procedures, and allowance by SMC and RUMC.
USMI’s FDA Phase 2 Multi-Center Clinical Trial is expected to take place in Q/4 2023.
The accompanying report for this Phase 1 Clinical Trial has been submitted to a peer review journal. The Abstract can be viewed on the ASCO (Free ASCO Whitepaper) website at View Source
Reference data1 JCRI Discovers the Mechanism using Canady Helios Cold Plasma to Induce Cell Death in Breast Cancer
For more information about the CHCP clinical trial and USMI’s innovative medical technologies, please visit ClinicalTrials.gov identifier: NCT04267575.