A Diagnostics & Imaging Week

Aethlon Medical (San Diego) reported that its Hemopurifier, a device developed to treat drug- and vaccine-resistant pathogens, was presented as a candidate treatment for drug resistant HIV patients at The AIDS Institute's Treatment Horizons Forum held in conjunction with the XVI International AIDS Conference.

Aethlon said that the Hemopurifier, if commercialized, would represent the first medical device enlisted as a treatment for HIV/AIDS.

James Joyce, CEO and chairman of Aethlon, presented the device at the meeting, and the company said that he has accepted a second invitation from The AIDS Institute to present at the AIDS Global Village located in the Metro Toronto Convention Centre, host site of the AIDS conference.

The presentation by Joyce highlighted that the Hemopurifier:

• has been developed to address the treatment of drug- and vaccine-resistant pathogens, including HIV.

• is a medical device designed to mimic the natural immune response of clearing infectious viruses and toxins before the occurrence of cell and organ infection.

Aethlon said that human in vitro blood studies have documented a rapid capture of circulating HIV and gp120, a toxic surface protein known to deplete the immune T-cells required to fight off infection.

Aethlon researchers said they have immobilized affinity agents within the Hemopurifier that have been verified by the National Cancer Institute (NCI) and the National Institutes of Health (NIH; both Bethesda, Maryland) to have activity against all strains of HIV. By targeting the clearance of all HIV strains, including untreatable sub-species, the Hemopurifier provides treatment hope for the large and growing population of multiple drug resistant (MDR) patients.

Joyce emphasized that the Hemopurifier is not a suitable treatment option for individuals still able to suppress viral load with antiretroviral (ARV) drug regimens.

The company reported that a recent human safety study in health-compromised individuals documented the application of 24 Hemopurifier treatments, each lasting four hours, without any material adverse events. The study, performed at The Apollo Hospital (Delhi, India), enrolled patients with both kidney failure requiring dialysis, and advanced liver disease as a result of hepatitis-C (HCV) infection. Aethlon also documented a significant capture of HCV (about 2 billion copies +/- 8.4%) in tested Hemopurifier cartridges.

Aethlon said it plans to continue testing of the Hemopurifier in India, and that it has initiated discussions with the National Aids Research Institute (NARI), a government agency overseeing the 7.5 million HIV-infected patients in India, regarding a potential study to treat infected individuals in that country.

The company also confirmed it has filed a pre-investigational device exemption meeting submission with the FDA to review a plan to test the Hemopurifier as a broad-spectrum countermeasure against drug and vaccine resistant bioweapon threats, and pandemic influenza.

The Treatment Horizons Forum provides the medical, scientific and HIV-infected community the opportunity to learn about promising new developments in HIV/AIDS research.

In other news from the conference:

• Chembio Diagnostics (Medford, New York) is featuring at the conference a new alternative procedure for performing its HIV 1/2 STAT-PAK Dipstick rapid test.

Larry Siebert, CEO of Chembio, said, "There is greater recognition of how vital rapid testing is to achieving the goals of the conference; prevention, treatment and worldwide care. The ability to know one's status within 15 minutes of utilizing a rapid HIV diagnostic test is powerful information. The increasing awareness that treatment is available is encouraging more and more people to get tested worldwide."

Chembio has three rapid HIV tests, two of which received FDA approval in May. HIV 1/2 STAT-PAK Dipstick is a lower-cost version that is used in donor-funded programs; it is the only rapid HIV test offered through the Clinton Foundation's HIV/AIDS Initiative (CHAI) that is manufactured by a company with FDA-approved rapid HIV tests.

The company said that the test can be performed with two flexible testing procedures: The new procedure allows one to place the test strip on a flat laminate card and run the test like a standard cassette test, but without the cost and weight of cassette components. Customers can still choose to use the original tube procedure that has been provided for the dipstick. These two testing procedures allow customers the convenience of choosing the method best suited to their testing environment, according to the company.

• Calypte Biomedical (Lake Oswego, Oregon), a test maker for the professional point-of-care and over-the-counter (OTC) segments of the market primarily for the detection of antibodies to HIV, presented an abstract entitled "Initial evaluations of a novel rapid test for HIV-1/2 antibodies in blood or oral fluid," Abstract: CDB0076, on its research to develop a new HIV 1/2 rapid test format for use on whole blood and plasma and oral fluid specimens at the conference.

The data contained in the abstract relates to the company's second-generation rapid testing platform Aware2 prototype, currently being developed as an HIV screening test. The platform is based on technology licensed from Ani Biotech Oy of Finland and allows the company to enter new markets, including the U.S., where its current Aware line of rapid tests is not available.

The company said preliminary results of an internally conducted study for the Aware2 HIV-1/2 rapid blood test's sensitivity equals or exceeds that of most FDA approved EIA tests.

The company's current Aware HIV-1/2 rapid blood and oral fluid tests also exceed most FDA-approved EIA tests, according to the company. The study demonstrated "excellent" concordance for matched blood- based and oral fluid specimens with the Aware2 HIV-1/2 prototype test. These findings are the first step in what the company hopes will result in a formal submission to the FDA for its Aware2 HIV-1/2 rapid blood and saliva tests.

Dr. Ron Mink, Calypte's chief scientific officer, said, "The data we have assembled are very encouraging, in terms of pre-clinical performance characteristics. The test is easy to use and versatile, demonstrated by its ability to detect antibodies to HIV in either oral fluid or blood. The visualizing agent is not part of the test strip, which differentiates it from lateral flow HIV tests currently available and appears to improve sensitivity."

Roger Gale, Calypte's chairman and CEO, said, "As Dr. Mink noted, the initial results are encouraging. This format is quite sensitive. The Aware2 line is an important opportunity for us. An FDA advisory panel has recently supported the development of a process to bring a HIV OTC test to the U.S. market and the Aware2 platform is particularly suitable for OTC applications."

Gale added, "Calypte is uniquely poised to deliver to the U.S. OTC markets rapid tests for HIV and other diseases of public health interest. We plan to use the Aware2 platform to develop a line of diagnostic tests for STDs, with the initial test expected to be syphilis. Initial feasibility research is under way in collaboration with the Centers for Disease Control and Prevention [Atlanta]."