SAN DIEGO, September 30, 2021 / PRNewswire / – Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious diseases, today announced that it has entered into an agreement with PPD, Inc. ( Nasdaq: PPD), a leading global contract research organization (CRO), for PPD to oversee the company’s clinical studies of the hemopurifier, Aethlon’s therapeutic blood filtration system, for the indications of Infectious diseases.
Under the agreement, PPD will manage Aethlon’s ongoing hemopurifier study for patients with severe COVID-19 (NCT04595903). PPD and Aethlon may also agree to include additional studies as part of their agreement.
“Aethlon is committed to advancing the clinical development of the hemopurifier,” said Charles J. Fisher, MD, CEO of Aethlon Medical. “PPD is a world-class organization with significant experience in conducting clinical studies. Aethlon plans to act quickly to leverage this experience to advance our hemopurifier studies in COVID-19 patients. “
About Aethlon and the Hemopurifier®
Aethlon Medical is a biotechnology company developing Hemopurifier, a therapeutic blood filtration system indicated for infectious diseases and cancer, as an advanced technology. In human studies, the Hemopurifier has been shown to remove potentially fatal viruses and harmful exosomes from the blood using proprietary lectin-based technology. This action has applications in cancer, where exosomes can promote immune suppression and metastasis, and in potentially fatal infectious diseases.
The hemopurifier is a revolutionary device designated by the United States Food and Drug Administration (FDA), indicated for the treatment of people with advanced or metastatic cancer who do not respond or tolerate standard therapy, and with types of cancer in which exosomes have been shown to participate in the development or severity of the disease. As part of an Investigational Device Exemption (IDE) request, the FDA approved a single-site open-label early feasibility study (EFS) to evaluate the hemopurifier to reduce cancer-associated exosomes prior to administration of the standard of care pembrolizumab (KEYTRUDA®) in patients with recurrent and / or metastatic squamous cell carcinoma of the head and neck. The EFS is conducted at University of Pittsburgh Hillman Cancer Center Medical Center.
Hemopurifier also holds an FDA Breakthrough Device designation and an open IDE application related to the treatment of life-threatening viruses that are not treated with approved therapies. A recent amendment to the IDE allowed Aethlon to implement a new EFS protocol to treat up to 40 COVID-19 patients at up to 20 clinical sites in the United States. SARS-CoV-2 spike protein and removal of SARS-CoV-2 virus from the circulation of a human patient.
Additional information is available at www.AethlonMedical.com.
PPD is a leading global contract research organization providing comprehensive and integrated drug development, laboratory and lifecycle management services. Our customers and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With more than 30,000 professionals worldwide, PPD has conducted clinical trials in more than 100 countries to help clients provide life-changing therapies to improve their health. We apply innovative technologies, therapeutic expertise and a strong commitment to quality to bend the cost and time curve of drug development and optimize value. For more information, visit www.ppd.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may”, “believe”, “anticipate”, “expect”, “intend”, “plan”, “plan”, “” “will”, “projects” , “Estimate”, “potentially” or similar expressions constitute forward-looking statements. These forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based on Aethlon’s current expectations and involve assumptions which may never materialize or may prove to be inaccurate. Factors that may contribute to such differences include, but are not limited to, the Company’s reliance on PPD to manage its clinical trials under the framework service agreement between the parties, the ability of the Company to Company to enroll patients and complete its trials in COVID-19 patients and in its head and neck cancer trials, the Company’s ability to successfully treat patients in any route of emergency use, the Company’s ability to complete the development of its hemopurifier and other potential risks. The above list of risks and uncertainties is illustrative, but not exhaustive. Additional factors that could cause results to differ materially from those anticipated in the forward-looking statements can be found under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended. March 31, 2021, and in other documents filed by the Company with the Securities and Exchange Commission, including its quarterly reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as required by law, the Company does not intend, nor assume any obligation, to update this information to reflect future events or circumstances.
Company details :
Aethlon Medical, Inc.
Tony russo, Ph.D.
Russo Partners, LLC
SA Noonan Communications, LLC
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SOURCE Aethlon Medical, Inc.