Aethlon Medical, Inc., a company developing medical technology to treat cancer and life-threatening infectious diseases, announced that it has entered into an agreement with NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end development services to oversee the company's clinical trials investigating the Hemopurifier, Aethlon's immunotherapeutic device, for oncology indications.
Pursuant to the agreement, NAMSA will manage Aethlon's study of the Hemopurifier for patients in the United States and Australia with various types of cancer tumours. It is anticipated the initial clinical trials will begin in Australia.
"Aethlon is committed to progressing the clinical development of the Hemopurifier," said Charles J. Fisher, M.D., chief executive officer of Aethlon Medical. "NAMSA is a world class organization with significant experience managing clinical studies. Aethlon plans to move quickly to leverage this experience to advance our trials with the Hemopurifier in cancer patients."
"We are extremely pleased that Aethlon selected NAMSA as their strategic outsourcing partner for their clinical research programme," stated Dr Christophe Berthoux, NAMSA CEO. "NAMSA's mission is to deliver best-in-class global MedTech solutions, and with increasing demand to find trusted outsourcing partners to accelerate efficient clinical development of life-changing medical products, we are well positioned to work collaboratively with Aethlon," Dr. Berthoux concluded.
The Hemopurifier is a US Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease.
The Hemopurifier also holds an FDA Breakthrough Device designation and an open IDE application related to the treatment of life-threatening viruses that are not addressed with approved therapies.
Aethlon Medical is a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases.
Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world's leading MedTech Contract Research Organization (CRO) offering global end-to-end development services
