AEMD: Hemopurifier Hemopurifier To Be Studied in a Variety of Solid Tumors

By M. Marin

NASDAQ:AEMD

READ THE FULL AEMD RESEARCH REPORT

Studying the Hemopurifier in a range of cancers

Aethlon Medical’s (NASDAQ:AEMD) provided a business update. AEMD has been working to launch a blanket oncology trial to study the impact of the Hemopurifier on a variety of cancerous tumors. The company’s goal is to build its database in oncology to help with the development of the Hemopurifier as an oncology treatment. The company is fairly advanced in the selection of a new CRO (contract research organization) to supervise the planned oncology study in the U.S. and in Australia (see below). The results of such a trial, if positive, could have broad commercial and economic implications for AEMD, in our view.

Given the Hemopurifier’s demonstrated ability to remove exosomes, management believes the device can be used to affect improved outcomes in a number of cancers and will be studied in conjunction with a checkpoint inhibitor such as Keytruda. Keytruda has been used to treat 25+ different types of cancer. The company expects the Hemopurifier, in conjunction with an inhibitor, can help improve overall patient outcomes and demonstrate proof of concept about the device’s benefits in treating solid tumors.

The company’s earlier trial focused exclusively on the head & neck cancer is being discontinued. Reflecting a lack of patient enrollment by the University of Pittsburgh Medical Center (UPMC) in that safety trial, the company and UPMC decided to terminate it.

Financial funding to move trials forward

The company’s actions are intended to maximize its potential to receiving regulatory approval and funding to advance clinical research and accelerate time to market.

▪ AEMD had $19.6M of cash at the end of 2Q FY 2023 (which equates to about $1 per share).

▪ The company expects to realize cost savings of up to $5M by discontinuing the U.S. COVID study.

▪ AEMD intends to allocate the funds to advancing the oncology & potentially other studies.

Regarding the U.S. COVID-19 study, the company recently decided to terminate the agreement with its CRO due to a scarcity of COVID patients in intensive care units eligible for enrollment. AEMD will discontinue COVID clinical trial activity in the U.S., although its Investigational Device Exemption (IDE) related to severe viral infections remains open. The company expects the decision to discontinue this study to result in cost savings of up to $5 million in the next year. AEMD intends to allocate these funds to advancing the blanket oncology study.

Australia: Positive Market For Conducting Clinical Research

The company launched a wholly owned subsidiary in Australia during the quarter. This subsidiary is designated to conduct clinical research, seek regulatory approval, and commercialize the Hemopurifier in Australia, beginning with an initial focus on the oncology market. The company expects a new CRO will supervise planned oncology studies in the U.S. and Australia.

Aethlon believes Australia offers several advantage for conducting clinical trials, including R&D tax incentives offered by the government. This program enables companies to receive a tax rebate of up to 43.5% on clinical trial related R&D costs. AEMD expects this program can help it reduce costs, lower risk, and accelerate time to market. The company’s believes Australia provides a competitive research environment; management’s comments indicate that data generated in Australia has generally been accepted by the FDA.

India

AEMD’s COVID-19 trial site in India is open. AEMD will shift cartridges to India to use in the COVID-19 study there at Medanta Medicity Hospital, a multi-specialty hospital in Delhi, India. The venue has enrolled one patient in the COVID-19 trial and continues to screen patients actively. The company intends to enroll additional COVID-19 patients. Moreover, the CRO, Qualtran LLC, has identified other potential sites for the trial and is determining the feasibility of adding additional venues.

Separately, AEMD is also considering launching an oncology trial in India. Regulatory authorities in India have accepted a manufacturing change (see below) and the company plans to ship new cartridges to India for use in the company’s clinical trials there.

The addition of a second supplier for Galanthus nivalis agglutinin (GNA) that AEMD uses in the resin of the Hemopurifier is pending FDA approval of a supplement to the company’s IDE. The FDA has requested additional data, which might take several months to obtain. Although AEMD believes the FDA has mandated unexpectedly high testing requirements for a product in the safety and feasibility stage of development and is engaging the FDA's ombudsman, it is uncertain at this point that the company can help shorten its development timelines.

Future uses of the Hemopurifier include treatment of COVID-19, Monkeypox & other infectious diseases

The Hemopurifier’s effectiveness has already been demonstrated in humans in single patient emergency use cases in COVID-19 and in in vitro analysis. AEMD intends to continue to demonstrate the effectiveness of the Hemopurifier in a broad range of viruses and conditions, including COVID-19 and various variants and Monkeypox, via in vitro methods and single patient emergency uses when warranted. The company has engaged a key testing lab in Columbus, Ohio, Battelle, to perform an in vitro study to examine the binding of the current Monkeypox strain to a miniature version of the Hemopurifier.

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