Aethlon Receives Clearance From Drug Controller General of India For Potential Phase 1 Trial of its Hemopurifier® in Oncology
Aethlon Medical, Inc. has recently received clearance from the Drug Controller General of India (DCGI) to conduct a phase 1 trial of its Hemopurifier® in patients with solid tumors. This trial will focus on patients who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.
The Hemopurifier® is a clinical stage immunotherapeutic device developed by Aethlon Medical. It has shown promising results in removing life-threatening viruses and harmful exosomes from blood, making it a potential treatment option for cancer and life-threatening viral infections.
The phase 1 trial in India will be a safety study involving nine to 18 patients with solid tumors. The primary objective of the trial is to assess the safety and feasibility of the Hemopurifier® in patients who have not responded to or cannot tolerate standard of care therapy. The trial will also evaluate the effects of Hemopurifier® treatment on the immune response to cancer.
Charles J. Fisher, Jr., M.D., Chief Executive Officer of Aethlon Medical, expressed his excitement about receiving clearance for the trial, stating that it is an important step in evaluating the Hemopurifier® as a treatment option in multiple tumor types. He also mentioned that the company plans to initiate a similar oncology clinical trial in Australia.
Aethlon Medical is focused on developing innovative medical therapies, and the Hemopurifier® is a significant part of their portfolio. The device has received Breakthrough Device designations from the U.S. Food and Drug Administration (FDA) for the treatment of advanced or metastatic cancer and for the treatment of life-threatening viruses that have no approved therapies.
The company is working closely with North American Science Associates, LLC (NAMSA), a contract research organization, to initiate the clinical trial in Australia. These planned trials will provide valuable insights for future efficacy trials with the Hemopurifier® in oncology.
Aethlon Medical’s dedication to developing groundbreaking therapies for cancer and life-threatening viral infections is commendable. The clearance from the DCGI to conduct the phase 1 trial in India is a significant milestone for the company. With the potential to improve patient outcomes and address unmet medical needs, the Hemopurifier® holds promise as a valuable addition to the field of immunotherapy.
For more information about Aethlon Medical and the Hemopurifier®, please visit their website at www.AethlonMedical.com.