ExThera Medical Celebrates Successful Completion of Trial
ExThera Medical is thrilled to announce the successful conclusion of its Phase I OSCAR I Trial at the OU Health Stephenson Cancer Center. This trial focuses on examining how effective the ONCObind Procedure Hemoperfusion Filter is in removing Circulating Tumor Cells (CTCs) from patients fighting metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
Key Highlights from the Trial
The objective of the OSCAR study is to evaluate the early safety and effectiveness of the ONCObind Procedure. A total of five patients with PDAC have undergone the procedure so far. They've reported no safety issues and have shown promising results. Following this, ExThera has sent data to the FDA for review, hoping to receive approval to advance to the next phase of the feasibility trial (OSCAR II) and to broaden the study to include patients with Metastatic Colorectal Cancer (MCRC) in addition to those with metastatic PDAC.
Encouraging Patient Outcomes
Dr. Bob Ward, Chairman and President of ExThera Medical, expressed his contentment with how well the ONCObind Procedure was received by patients. Notably, there was a significant reduction in sedimentation rates, along with an improved appetite, suggesting a positive response to the treatment.
Collaboration for Future Research
Sanja Ilic, Chief Regulatory Officer for ExThera, commended the collaborative efforts with the team at Stephenson Cancer Center. She looks forward to continuing their partnership on future studies, not only focused on pancreatic cancer but also potentially extending into colorectal cancer.
Understanding the ONCObind Procedure
The ONCObind Procedure signifies a promising step forward in cancer treatment technology. It employs ExThera’s proprietary Onco-Seraph platform, an extracorporeal blood filtration system engineered to effectively eliminate CTCs from patients' bloodstreams. CTCs contribute to the spread of cancer and play a key role in its progression.
How the Technology Works
Utilizing the ONCObind Procedure along with the Seraph® 100 Microbind® Affinity Blood Filter, this therapy captures and removes these dangerous cells, potentially leading to better outcomes for patients with metastatic conditions. The effectiveness of this innovative technology has been backed by various studies, which show a trend toward improved clinical results in severely ill patients.
ExThera’s Dedication to Healthcare Innovations
ExThera is committed to creating groundbreaking medical solutions, particularly for serious health issues like sepsis and COVID-19. Their products are designed to meet urgent healthcare needs, whether in hospitals, clinics, or emergency settings.
About ExThera Medical Corporation
Founded with the goal of advancing blood filtration technology, ExThera Medical Corporation specializes in developing and commercializing cutting-edge medical devices. Their standout product, the Seraph® 100 Microbind® Affinity Blood Filter, shows potential for removing a variety of pathogens from the bloodstream. Supported by a growing collection of evidence highlighting its effectiveness, ExThera’s technology is making an impact in the fight against infections for patients from all walks of life.
A Global Presence
The Seraph® 100 has received CE Mark certification and is readily available throughout the EU, showcasing ExThera's global influence. In the United States, the FDA has granted Emergency Use Authorization (EUA) specifically for its application in treating COVID-19 patients, highlighting the device's significance in addressing critical health emergencies.
Frequently Asked Questions
What is the main aim of the OSCAR I Trial?
The OSCAR I Trial aims to evaluate the safety and efficacy of the ONCObind Procedure Hemoperfusion Filter in removing Circulating Tumor Cells from patients with metastatic PDAC.
How many patients participated in the OSCAR I Trial?
A total of five patients with metastatic PDAC completed the ONCObind Procedure during the trial.
What were the outcomes reported from the trial?
Participants reported no safety concerns, along with rapid reductions in sedimentation rates and improvements in appetite.
What is the Seraph® 100 Microbind® Affinity Blood Filter?
This is an investigational blood filter device designed to remove a range of pathogens from the bloodstream, contributing to improved patient outcomes.
Is ExThera’s technology available worldwide?
Yes, the Seraph® 100 is available in the EU under CE Mark and has received EUA from the FDA for use in the U.S. for COVID-19 treatment.
