AEMD: New CRO to Help Advance Studies; Expanded Team to Facilitate Efforts

·3 min read

By M. Marin



New CRO to facilitate study of the Hemopurifier® in a range of cancers

To advance its medical device, the HemoPurifier®, through clinical studies towards potential regulatory approval and commercialization, Aethlon Medical’s (NASDAQ:AEMD) has launched several recent initiatives. Among other steps, the company has:

▪ Embarked on launching a blanket oncology study in Australia

▪ Appointed a CRO to oversee this and other studies

▪ Hired a new Chief Scientific Officer

▪ Formed a materials transfer agreement to study the HemoPurifier in “Long COVID-19”

… new study design expected to facilitate trial enrollment…

AEMD is launching a blanket oncology trial to study the impact of the Hemopurifier on a variety of cancerous tumors. By shifting its focus from studying the Hemopurifier in only head-and-neck cancer (an earlier study at the University of Pittsburgh Medical Center that focused exclusively on head & neck cancer was terminated, reflecting a lack of patient enrollment, in part due to COVID-19), the company believes it has improved prospects for patient enrollments and for building a database to support regulatory approval. The company expects multiple medical centers to participate in the study, which expands the opportunities for patient enrollment. Moreover, the company has also expanded the opportunities for patient enrollment by including patients with a variety of solid tumors. If the study shows the Hemopurifier to be beneficial in multiple cancer types, the company believes the data will support the broad utility of the device.

Australia The company created a wholly owned subsidiary in Australia to conduct clinical research, seek regulatory approval, and commercialize the Hemopurifier in Australia. Aethlon believes Australia offers several advantages 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 believes Australia provides a competitive research environment; importantly, management’s comments indicate that data generated in Australia has generally been accepted by the FDA.

… also demonstrate broad potential utility of Hemopurifier …

The company’s goal is to build its database in oncology to help with the development of the Hemopurifier as an oncology treatment. AEMD is optimistic that the results of the study will support the utility of the Hemopurifier for a range of oncology indications. Thus, depending on the results of the study, the study could have broad commercial and economic implications for AEMD, in our view.

The company has selected a new CRO (contract research organization) to supervise the planned oncology study in Australia and in the U.S. AEMD recently contracted with NAMSA, LLC, a prominent MedTech CRO that operates globally. The new oncology clinical trial is planned to be a safety, feasibility and dose finding trial in solid tumors failing anti-PD-1 antibodies.

… & potentially contribute to meaningful improvements in patient outcomes …

According to the NIH (National Institutes of Health), “The percentage of patients estimated to respond to checkpoint inhibitor drugs was 0.14% in 2011 and increased to 12.46% in 2018.” AEMD places the percentage higher at this point, at an estimated roughly 30%. That means that the majority of patients do not respond to checkpoint inhibitors. The company’s hypothesis is that using the Hemopurifier to remove exosomes, in conjunction with treatment of checkpoint inhibitors, can increase the percent of patients who can benefit from combined treatment.

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.

… & maximize R&D spending …

By focusing clinical efforts in Australia, as well as India and subsequently the U.S., the company expects to realize cost savings and maximize its R&D spending. The company’s plan is to maximize its R&D spending and benefit from attractive economic incentives the Australian government provides for clinical development efforts and the generally lower cost of clinical development efforts in India.

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