Aethlon Medical Advances Hemopurifier® Cancer Trial Efforts
Aethlon Medical Receives Ethics Committee Approval
Aethlon Medical has achieved a significant milestone by securing full ethics approval from the Medanta Institutional Ethics Committee. This approval pertains to a critical clinical study involving the Hemopurifier®, aimed at assessing its safety, feasibility, and optimal dosage in cancer patients who have solid tumors and have not responded to established treatments using anti-PD-1 antibodies.
Details of the Clinical Trial
The authorization for the clinical trial represents a vital step in Aethlon’s strategy to explore the Hemopurifier as a potential therapeutic option for various tumor types. These specific tumors often produce exosomes that can contribute to immune suppression and cancer spread, complicating treatment outcomes. The study protocol has garnered enthusiasm from the medical community, especially as it aims to recruit patients soon.
Clinical Trial Objectives
Designed as a safety and feasibility study, researchers will focus on how well the Hemopurifier performs in reducing levels of cancer-associated exosomes in the blood. Improvements in these levels might correlate with better outcomes when combined with traditional therapies such as Keytruda® or Opdivo®, which some patients struggle to benefit from.
Key Participants in the Study
The trial is backed by a knowledgeable team led by Dr. Ashok K. Vaid at Medanta Medicity Hospital and Dr. Puneet Sodhi from the Department of Nephrology, who boasts extensive experience with Hemopurifier treatments. Their collaborative effort underscores Aethlon's commitment to advancing cancer treatment through innovative technology.
The Hemopurifier® Technology Explained
At the heart of Aethlon Medical’s approach is the Hemopurifier®, an immunotherapeutic device engineered to filter harmful exosomes from the blood. This technology employs proprietary lectin-based mechanisms, designed specifically to combat the challenges posed by these vesicles in cancer patients. By targeting these exosomes, the Hemopurifier® could potentially enhance the therapeutic responses in patients receiving conventional cancer treatments.
Potential Impact on Cancer Treatment
Currently, only about 30% of patients treated with pembrolizumab or nivolumab experience significant and lasting responses. The incorporation of the Hemopurifier into the treatment regimen could improve these outcomes by reducing the factors that lead to treatment resistance. Preclinical studies have shown promise in this area, with a reduction in exosome levels observed in the laboratory.
Trial Design and Monitoring
During this trial, approximately 9 to 18 patients will be monitored closely for safety and any adverse effects. The structure of the trial allows for detailed analysis after initial treatments, facilitating adjustments that could optimize patient outcomes. The insights gained are expected to inform future studies and regulatory submissions moving forward.
About Aethlon Medical
Aethlon Medical is dedicated to pioneering treatments that address critical health challenges associated with cancer and severe infections. Its flagship device, the Hemopurifier®, has garnered attention for its innovative application in various therapeutic contexts. This device is not only aimed at cancer treatment but also shows potential in tackling life-threatening viral infections, showcasing the versatility and essential role of this technology in medicine.
Frequently Asked Questions
What is the purpose of the Hemopurifier® trial?
The trial seeks to evaluate the safety, feasibility, and appropriate dosing of the Hemopurifier® in cancer patients who are not responding to traditional anti-PD-1 treatments.
Who is leading the clinical trial?
Dr. Ashok K. Vaid at Medanta Medicity Hospital will lead the trial, supported by Dr. Puneet Sodhi, who has significant experience with Hemopurifier treatments.
Why are exosomes a concern in cancer therapy?
Exosomes can contribute to immune suppression and facilitate cancer progression, making them a key target for therapies aimed at enhancing treatment effectiveness.
What are the next steps after receiving ethics approval?
The next steps involve recruiting eligible patients for the trial and commencing treatment protocols as outlined in the study design.
Is the Hemopurifier® recognized by regulatory bodies?
Yes, the Hemopurifier® has been designated as a Breakthrough Device by the U.S. FDA and has an open Investigational Device Exemption (IDE) application.
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