The number of med-tech companies that could possibly rival the patience of Aethlon Medical (San Diego) might be few and far between. Since 2001, the company has held its hopes on its Hemopurifier being used to treat HIV Infection.

Most recently, the company began inching towards turning that hope into cold, hard reality when it reported that it planned to initiate a first-in-man clinical study of the device (Medical Device Daily, June 25, 2008). The company said it initiated the study in September.

The device is said by Aethlon to have the potential to extend the lives of HIV patients by removing HIV strains that cause drug failure and reducing the presence of viral proteind that kill off immune cells.

The HIV treatment studies are being conducted at Jattinder Gambhir Hospital (J.G. Hospital; Punjab, India) and Bhvani Hospital (Bihar, India).

According to Aethlon, up to six HIV-infected patients will be administered daily Hemopurifier treatment for a period of up to nine consecutive days.

"Right now we're in the process of looking at the data for four different patients who might be eligible for the process," Jim Joyce, chairman/CEO of Aethlon, told Medical Device Daily. "We expect to treat the first patient in the next few weeks.

"Based on our recent hepatitis C treatment observations, I am increasingly confident that our Hemopurifier will demonstrate similar effectiveness in HIV studies," he said. "If correct, the Hemopurifier will advance HIV care by offering a treatment option that extends life for patients no longer responsive to drug therapy, and enhances the benefit of drug regimens by inhibiting the proliferation of HIV strains that cause drug resistance."

The device provides a mechanism which to mimic the natural immune response of clearing infectious viruses and toxins before cells and organs can get infected.

The goal of Hemopurifier treatment is to inhibit viral replication through the rapid clearance of all strains of infectious HIV, and to augment the immune response by eliminating circulating gp120, a protein that sheds from the surface of HIV to kill-off immune cells necessary to fight infection.

The company said the study is expected to be completed in 1Q09.

"If studies go well we would expect commercialization in India in 2009, with commercialization in the U.S. and [Europe] in late 2010 and early 2011," Joyce said.

On Sept. 17, Aethlon disclosed preliminary data resulting from hepatitis C (HCV)-infected patients being treated with the Hemopurifier (a separate matter, yet related). The HCV-treated patients were among end-stage renal disease patients enrolled in human safety studies being conducted at the Fortis Hospital (Delhi, India). In the HCV studies, an average viral load reduction of 82% was observed in patients after just three Hemopurifier treatments.

The study data documented that two of three patients infected with HCV responded with measurable viral load reductions during the course of three 4-hour Hemopurifier treatments.

The three treatments were administered during scheduled dialysis therapy every other day over the span of five days. The third patient showed both increases and decreases in viral load during the course of treatment, but demonstrated significant overall reduction of viral load in follow-on tests. Given the small sample size, viral load data was averaged for all three patients. Average initial HCV viral load was 3.13 x 108 viral units per ml of blood. After completion of three Hemopurifier treatments, viral load was reduced an average 57%.

The stepwise drop in HCV viral load averaged 36% per treatment. Follow-on testing indicated that HCV viral load was 60% lower than initial viral load values when measured three days after final Hemopurifier treatment, and at seven days post-treatment, viral load declined to 82% below starting viral load values.

None of the patients were being treated with antiviral drug therapy. Viral load measurements were performed with real-time quantitative polymerase chain reaction (RT-PCR). Control samples were measured in duplicate while treatment samples were generally measured in triplicate.

The company first introduced the device seven years ago during the annual National Blood Safety Conference in Washington (MDD, Feb. 9, 2001). The device is a hollow-fiber dialysis cartridge and can reduce the viral load through the direct physical removal of the HIV in circulation.

Since the device's inception, Aethlon has retooled it and filed for patents to seek its improvement. One such modification stems from the filing for a provisional patent submission titled, "Method and Apparatus for Increasing Contaminant Clearance Rates during Extracorporeal Fluid Treatment," with the U.S. Patent and Trademark Office (MDD, March 8, 2007).

The patent describes technical improvements to the Aethlon Hemopurifier that increase the rate of capture of undesirable blood contaminants including viruses, toxins and immunosuppressive particles associated with cancer.

The company said the device also holds promise in cancer care, as research studies have verified the Hemopurifier is able to capture immunosuppressive particles secreted by tumors.

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