Capture Tumor-Derived Exosomes Underlying Several Forms of Cancer
Upwards of 90% of all cancer-related deaths are attributed to metastasis. The spread of cancer from a primary site of origin to other organs or areas of the body. The mechanism of how tumors metastasize to distant sites in the body has long been one of cancer's greatest mysteries. That mystery was recently solved when circulating particles known as tumor-derived exosomes were discovered to be the seeds that promote the spread and growth of cancer metastasis.
Aethlon initiated its tumor-derived exosome research at a time when the medical community believed exosomes were merely cellular debris with no biological function. Today, a therapeutic to address tumor-derived exosomes represents a significant unmet need in cancer care. Aethlon has demonstrated that the affinity mechanism of the Hemopurifier® can capture tumor-derived exosomes and exosomal particles underlying several forms of cancer, including breast, ovarian and metastatic melanoma.
Our extended tumor-derived exosome research
Beyond their role in metastasis, researchers have also published mounting evidence that tumor-derived exosomes contribute to tumorigenesis (the formation of cancer), cancer progression, angiogenesis (creation of blood vessels to fuel tumor growth), immune evasion, and resistance to radiation and chemotherapeutic drugs. Recent discoveries also reveal that exosomes may contribute to bacterial and viral pathogenesis, the progression of Alzheimer and Parkinson’s diseases, the spread of prion proteins, and numerous inflammatory conditions.
Status of clinical studies
We have recently launched in Australia and in India safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solidtumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo®(nivolumab). The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial in each country is safety.
Royal Adelaide Hospital in Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia have received training on the device and are now open for patient enrollment. The first patient was enrolled on October 29, 2024 at Royal Adelaide Hosptial and completed screening activities confirming their eligibility on November 8, 2024.
We have also trained a third hospital in Australia but have not yet received ethics committee approval for that institution and have not yet begun patient enrollment.
We have received ethics committee approval from Medanta Medicity Hospital in Gurugram, India for a similar nine to 18-patient, safety, feasibility and dose-finding trial. We are completing the necessary logistical steps before they can open for patient enrollment.
North American Science Associates, LLC ("NAMSA"), a world leading medical technology contract research organization ("CRO") offering global end-to-end development services is overseeing our clinical trials of the Hemopurifier for patients in Australia. We also have engaged Qualtran LLC as the CRO for our clinical trial in India.