A Medical Device Daily

Aethlon Medical (San Diego) reported that its Hemopurifier, a medical 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 ongoing this week in Toronto.

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

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 XVI International 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 afflicted 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.

In other news from the conference:

• Chembio Diagnostics (Medford, New York) is featuring 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.

• The Female Health Company (FHC; Chicago) at the meeting reported receiving notice from the World Health Organization (WHO; Geneva) that after a “stringent technical review” regarding design, product characteristics, quality control and manufacturing technology, the Female Condom 2 is, in principle, being manufactured to at least the same standard as the polyurethane female condom FC1.

In addition, the design and physical characteristics of FC2, supported by the clinical data, suggest that the two devices are functionally equivalent when used correctly. therefore, WHO said that the FC2 is acceptable for bulk procurement by United Nations agencies, subject to standard quality assurance measures.

The completion of WHO's review coincides with the conference in Toronto, which has as its theme the feminization of AIDS and focusing on strengthening women's rights, curbing gender discrimination and violence against women and empowering women to use prevention methods and negotiate safer sex with their husbands and partners.

“FHC appreciates the strong leadership that WHO, UNAIDS, UNFPA and other UN agencies have taken to help countries develop national distribution plans and create health education programs that teach women how to use the female condom and talk about it with their husbands and partners,” said Mary Ann Leeper, spokeswoman for FHC. “As the only available woman-initiated form of prevention against HIV, the female condom can provide millions of women with an essential tool to negotiate safer sex. The Female Health Company is committed to working with these agencies, national governments, and international [non-governmental organizations] to create cost-efficient bulk buying partnerships that will reduce the cost of the female condom significantly increasing the possibility of broader access to women.”

Women comprise about half of all people living with HIV worldwide, the company said. In sub-Saharan Africa — where the impact of the global HIV/AIDS pandemic is most intense — 74% of young people living with HIV are women.

Experts say the number of women with HIV is growing in part because women are twice as likely as men to contract HIV from an infected partner during unprotected heterosexual intercourse. In addition, women's susceptibility to HIV is compounded by gender inequality, limiting their ability to negotiate safer sex with husbands/partners.

“We need to use the tools that are available to women to prevent further feminization of the HIV pandemic, and the female condom is one such tool in the fight to save lives,” said Dr. Musimbi Kanyoro, general secretary of the World YWCA, an organization supporting programs for women in 122 countries.

FHC owns certain worldwide rights to FC Female Condom, including patents which have been issued in the U.S., the UK, Japan, France, Italy, Germany, Spain, China, Canada, New Zealand, South Korea and Australia.

It says that the Female Condom is the only product controlled by a woman that protects against sexually transmitted diseases, including HIV/AIDS and unintended pregnancy.