Since 2001 Aethlon Medical (San Diego) has bannered its Hemopurifier as potentially the first device that could be used to treat HIV infection. Now, seven years later, the company is on the brink of turning that potential into reality as it plans to initiate the first-in-man clinical study of the device to treat HIV.
The Aethlon Hemopurifier is created to provide real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. According to the company, the Hemopurifier holds promise to extend the lives of AIDS patients by removing HIV strains that cause drug failure and reducing the presence of viral proteins that kill off immune cells. The clinical study was approved by the Institutional Ethics Committee at the Jattinder Gambhir Hospital (J.G. Hospital; Punjab, India) and is expected to begin in September.
"The Hemopurifier provides a unique strategy to prolong the lives of AIDS patients who are increasingly becoming resistant to their drug regimens," James Joyce, Aethlon's CEO/chairman, said. "In the absence of a curative vaccine, the largest void in HIV care remains a method to slow the proliferation of drug resistant strains produced by the constantly mutating AIDS virus. Clinical validation that the Hemopurifier can fill this void would also establish the opportunity to enhance and extend the benefit of both established and candidate drug therapies."
The J.G. Hospital study will evaluate the treatment effectiveness of the Hemopurifier during single-use treatments lasting up to four hours as well as sustained benefit resulting from intermittent treatments administered thrice weekly during extended treatment periods.
"This is a very crucial study for us ... we believe we have developed methodologies that will allow real-time therapeutic filtration methods to transcend from dialysis into the disease and cancer world," Joyce told Medical Device Daily.
Aethlon introduced the Hemopurifier device seven years ago at the 7th annual National Blood Product Safety Conference in Washington (Medical Device Daily, Feb. 9, 2001). The system is a hollow-fiber dialysis cartridge that reduces viral load through the direct physical removal of the HIV in circulation. It is designed for use within an established infrastructure of dialysis machines in hospitals and clinics worldwide.
"What we're trying to do is mimic the natural immune response of clearing infectious viruses and toxins before cells and organs can be infected," Joyce said.
Aethlon says its Hemopurifier provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the treatment of drug and vaccine-resistant viruses. Additionally, the device holds promise in cancer care, as research studies have verified the Hemopurifier is able to capture immunosuppressive particles secreted by tumors, Aethlon noted.
If successful, the first-in-man study would provide Aethlon with an early commercialization opportunity in India, Joyce said, where there are an estimated 5.7 million people living with HIV/AIDS, giving India as an individual country the highest predominance of HIV.
"There is obviously a very significant opportunity both to help people, but at the same time to enroll patients at a level that will allow us to show clinical benefit," Joyce said.
He said it is difficult in the U.S. to find large populations of HIV/AIDS patients who are not already on drug therapy.
"So India certainly offers an opportunity to treat people that are progressing in the disease but who have not yet experienced the use of drug protocols," Joyce said. "We look at this as an opportunity to demonstrate performance without taking into account the use of drugs ... to see what this can do on its own."
The next step for the company, Joyce said, will be the transition to initiating human studies in the U.S. He said Aethlon has an IDE application on file with FDA related to a safety study that looks very similar to studies the company has been running overseas in India.
Aethlon also reported that two candidates remain to be enrolled and treated to complete human safety studies currently being conducted at the Fortis Hospital (Delhi, India). Completion of the study is anticipated, but not required to occur, in advance of the HIV treatment studies to be conducted at the J.G. Hospital. Aethlon previously demonstrated treatment safety of the Hemopurifier in a 24-treatment study conducted at the Apollo Hospital (also Delhi).
The Hemopurifier is designed to act both as a stand-alone therapeutic, and as an adjunct treatment to enhance clinical benefit of established therapies.
Earlier this month the company said that the Hemopurifier has proven effective in capturing the reconstructed Spanish Flu of 1918 (1918rv). During in vitro testing, high concentrations of 1918rv were rapidly depleted from cell culture fluid when circulated through the device. The Hemopurifier also has demonstrated effectiveness in capturing H5NI avian influenza (bird flu), the company said (MDD, June 4, 2008).
Aethlon is conducting studies to support the use of the Hemopurifier as a broad-spectrum treatment countermeasure against bioterror threats, including Smallpox, and Ebola, Marburg, and Lassa hemorrhagic fever. Regulatory and commercialization initiatives in the U.S. are presently focused on bioterror threats, while international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious disease conditions including HIV and hepatitis C. The company said it has submitted an IDE to FDA to advance Hemopurifier as a broad-spectrum treatment countermeasure against category "A" bioterror threats.