Aethlon Medical Announces Contract with NAMSA to Advance Hemopurifier Clinical Programs in Cancer

Rhea-AI Summary

Aethlon Medical, Inc. (Nasdaq: AEMD) announced a strategic agreement with NAMSA, a leading MedTech Contract Research Organization, to oversee clinical trials for its Hemopurifier device targeting cancer treatments. The trials will begin in Australia and include patients with various cancer tumors. Aethlon aims to expedite the clinical development of the Hemopurifier, which has shown promise in removing harmful exosomes and viruses from blood. The device is designated by the FDA as a Breakthrough Device for advanced or metastatic cancer therapies. This partnership is expected to enhance the efficiency and effectiveness of Aethlon's clinical research efforts.

Positive

• Strategic partnership with NAMSA to manage clinical trials for the Hemopurifier.
• Initial clinical trials anticipated to commence in Australia.
• FDA Breakthrough Device designation for the Hemopurifier, indicating potential market advantage.

Negative

• None.

SAN DIEGO, Jan. 30, 2023 /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 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 tumors. 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 program," 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.

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases. The Hemopurifier is Aethlon's clinical stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and harmful exosomes from blood, utilizing a proprietary lectin-based technology.  This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases.

The Hemopurifier is a U.S. 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.

Additional information can be found at www.AethlonMedical.com.

ABOUT NAMSA

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. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients' products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry's premier, trusted partner for successful development and commercialization outcomes. Web: namsa.com.

Forward Looking Statements

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," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such 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 upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's dependence upon NAMSA to manage its clinical trials under the Master Services Agreement between the parties, the Company's ability to enroll patients in and successfully its complete trials in cancer patients in Australia and the U.S., the Company's ability to successfully complete development of its Hemopurifier, and other potential risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2022, and in the Company's other filings 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 may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
917-513-5303

NAMSA Media Contact
Leah Davidson, MA, MBA
Sr. Manager, Global Marketing Communications
Email: ldavidson@namsa.com

View original content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-contract-with-namsa-to-advance-hemopurifier-clinical-programs-in-cancer-301732638.html

SOURCE Aethlon Medical, Inc.

FAQ

What is Aethlon Medical's recent partnership with NAMSA about?

Aethlon Medical has partnered with NAMSA to manage clinical trials for its Hemopurifier device targeting cancer treatments.

When will the Hemopurifier clinical trials begin?

The initial clinical trials for the Hemopurifier are expected to begin in Australia.

What is the significance of the FDA Breakthrough Device designation for Aethlon Medical?

The FDA Breakthrough Device designation for the Hemopurifier indicates it has potential advantages over existing treatments for advanced or metastatic cancer.

What types of cancer are the Hemopurifier trials targeting?

The trials will involve patients with various types of cancer tumors.

How does the Hemopurifier work in treating cancer?

The Hemopurifier is designed to remove harmful exosomes and viruses from the blood, potentially improving outcomes in cancer treatment.