Medical Company Secures Ethics Committee Approval For Major Cancer Trial
Aethlon Medical Receives Ethics Committee Approval for Hemopurifier® Cancer Trial.
Disclaimer: This article is intended for informational purposes only and does not contain any commercial or promotional content. The information provided is based on publicly available sources as of June 2024.
Aethlon Medical, Inc. (Nasdaq: AEMD), a pioneering medical therapeutic company dedicated to developing advanced treatments for cancer and life-threatening infectious diseases, has reached a milestone in its quest to improve cancer therapy outcomes. On June 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for Aethlon's safety, feasibility, and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors. These patients have shown stable or progressive disease during anti-PD-1 monotherapy treatment, including therapies such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The approval is valid for a period of three years, until June 13, 2027. This pivotal trial will be conducted by Professor Michael Brown and his experienced team at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.
Addressing the Challenge of Anti-PD-1 Therapy Resistance
The necessity of this trial arises from a critical challenge in current cancer treatment protocols. Despite the efficacy of anti-PD-1 therapies like pembrolizumab and nivolumab, only about 30% of patients receiving these treatments experience lasting clinical responses. This limited efficacy has been partly attributed to the role of extracellular vesicles (EVs) produced by tumors, which are implicated in both the spread of cancers and the development of resistance to anti-PD-1 therapies. The Aethlon Hemopurifier® is designed to address this issue by binding and removing EVs from the bloodstream, potentially improving response rates to these immune checkpoint inhibitors.
In preclinical studies, the Hemopurifier® has demonstrated its capability to reduce the number of exosomes—nano-sized vesicles released by cells, including cancer cells—from the plasma of cancer patient samples. This reduction could potentially diminish the immunosuppressive effects exerted by these exosomes, thereby enhancing the efficacy of anti-PD-1 therapies.
Dr. Steven LaRosa, Chief Medical Officer of Aethlon Medical, expressed the significance of the HREC approval, stating, "The approval from the Human Research Ethics Committee at Central Adelaide Local Health Network marks a significant milestone for Aethlon, as they deemed that our clinical study meets the requirements of Australia's National Statement on Ethical Conduct in Human Research." He added, "We look forward to working closely with Prof. Brown and his staff, and with our Contract Research Organizations, NAMSA and ReSQ Clinical Research. The next steps include submission to the Therapeutic Goods Administration (TGA), the national health regulatory agency of Australia, obtaining approval from the CALHN Research Governance Committee, and conducting a site initiation visit to facilitate patient enrollment. Following this Ethics Board approval, we plan to submit to the Ethics Committees at two additional sites in Australia and one in India."
Clinical Trial Design
The upcoming clinical trial aims to enroll approximately 18 patients and will focus primarily on safety, feasibility, and dose-finding. The trial will meticulously monitor any adverse events and clinically significant changes in lab tests of Hemopurifier®-treated patients with solid tumors who exhibit stable or progressive disease at different treatment intervals. The study includes a two-month run-in period of PD-1 antibody monotherapy (Keytruda® or Opdivo®). Patients who do not respond to this initial therapy will be eligible to enter the Hemopurifier® phase, where sequential cohorts will receive one, two, or three Hemopurifier® treatments during a one-week period. Apart from ensuring the safety of the Hemopurifier®, the study aims to determine the optimal number of treatments required to decrease the concentration of EVs in the bloodstream. Researchers will assess whether these changes in EV concentrations can enhance the body's natural ability to mount an immune response against tumor cells.
The Hemopurifier® is a clinical-stage immunotherapeutic device developed by Aethlon Medical. It is designed to combat cancer and life-threatening viral infections and is also intended for use in organ transplantation. By targeting and removing harmful substances from the bloodstream, such as EVs and viral particles, the Hemopurifier® aims to improve patient outcomes and extend survival rates. The successful completion of this trial could pave the way for new therapeutic strategies that significantly enhance the efficacy of existing cancer treatments. By addressing the challenge of EV-mediated resistance, the Hemopurifier® has the potential to improve the clinical responses of a broader patient population undergoing anti-PD-1 therapy. This trial not only represents a crucial step for Aethlon Medical but also holds promise for advancing cancer treatment modalities globally.
Aethlon Medical's receipt of ethics approval for its Hemopurifier® cancer trial marks a pivotal moment in the company's ongoing efforts to revolutionize cancer therapy. With the clinical trial set to commence under the guidance of Prof. Michael Brown and his team at the Royal Adelaide Hospital, the medical community eagerly anticipates the results that could transform the landscape of cancer treatment. The trial’s design, focused on safety and efficacy, aims to address the pressing issue of anti-PD-1 therapy resistance, offering hope for improved outcomes for patients with solid tumors.
Disclaimer: This article is intended for informational purposes only and does not contain any commercial or promotional content. The information provided is based on publicly available sources as of June 2024.
Real-time information is available daily at https://stockregion.net