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Trials of novel therapy device expanded to include dengue
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Aethlon Medical Inc. has entered into an agreement with Qualtran that would expand human clinical studies of its investigational therapy device to include patients with dengue infection, according to a press release.
The Hemopurifier (Aethlon Medical Inc.) is a broad-spectrum therapy that utilizes plasma membrane technology to capture and remove circulating viruses. It was developed as post-exposure treatment to help patients overcome illness from viral pathogens and augment drug therapy. Currently, there are no approved therapies or vaccines for dengue.
Qualtran, a contract research organization, has agreed to establish multiple dengue treatment sites, as well as recruit experts to establish a consensus on treatment protocols for dengue infection in advance of the 2015 outbreak season. Qualtran previously managed clinical studies of the investigational therapy in patients with HIV and hepatitis C virus infection in hospitals located in India.
Data from the dengue treatment study will be incorporated into a humanitarian device submission, which provides an alternative pathway for obtaining marketing approval from the FDA for medical devices used to treat conditions that affect fewer than 4,000 individuals in the United States each year.
Aethlon is also initiating an FDA-approved study of the device in individuals infected with HCV. According to the company, in vitro studies have demonstrated the device’s ability to capture a range of pathogens, including Ebola hemorrhagic virus, dengue virus, Lassa hemorrhagic virus, influenza A(H5N1) virus, the reconstructed 1918 influenza virus (r1918), influenza A(H1N1)pdm09, West Nile virus and monkeypox. Besides treating viral infections, the Hemopurifier was developed to target tumor-secreted exomes that promote cancer progression.
According to WHO, between 50 million and 100 million people are affected by dengue each year, and 2.5 billion people — more than 40% of the global population — are at risk for infection.