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Wednesday, December 1, 2010

VIRxSYS Announces ’Functional Cure’ for AIDS

By Annie Brown -

A functional cure for AIDS may be available for purchase in the next 5 to 7 years, according to Riku Rautsola, who heads VIRxSYS, a biotechnology company based in Gaithersburg, Md. At a recent American Public Health Association (APHA) 138th Annual Meeting & Exposition, Rautsola presented information on therapeutic and preventative HIV vaccines being developed by VIRxSYS. I spoke with Rautsola about this groundbreaking development, and its significance for people living with HIV/AIDS, the gay male community, and the world.

At the recent APHA Annual Meeting & Exposition, Rautsola presented his company’s vaccine at special session to discuss issues related to HIV. On Nov. 10, Rautsola announced that his company was on the verge of a vaccine that would not only improve the health and extend the lives of people infected with HIV, but also potentially lower the presence of the virus in bodily fluids so low that HIV transmission could be dramatically reduced.

For groups like the National Institute of Health (NIH) and the Center for Disease Control (CDC), preventing HIV transmission is a primary concern. So it is no surprise that Rautsola’s vaccine was of particular interest. His company, VIRxSYS is one of 15 biotechnology companies currently developing a therapeutic vaccine for HIV; that is, the vaccine should be given to people already infected with HIV.

"In matters of public health, there are always two issues," Rautsola noted, "the individual and the forward transmission. Various vaccines in development shown signs that they may reduce incidents of HIV developing into AIDS, and there are signs that some of these therapeutic vaccines suppress the virus enough that the individual would have such a low viral load that there is a very low chance of transmission."

’Therapeutic’ v. ’Preventative’ Cure
VIRxSYS is attempting to use genetic technologies to create a functional cure for AIDS. The company’s work diverges from the more commonly funded projects of finding a preventative HIV vaccine. Rautsola believes that developing a therapeutic cure should be given priority over the creation of a preventative cure.

"A therapeutic vaccine could provide a functional cure," he said. "A functional cure enables the individual to control the replication of the virus in their body, while also preventing transmission. For many people in resource-deprived environments, a cure for AIDS would be something that would potentially eradicate the disease. However, a preventative vaccine does not help the 36 million individuals who already have the HIV infection.

"HIV/AIDS is one of the smartest viruses on our planet," he added. "Preventative vaccines have been in development for 20 years and nothing has worked so far. They have proven to be difficult and expensive to develop. Some scientists have proposed that there may not be a preventative vaccine for HIV/AIDS. In order for the preventative vaccine to work, you would need a large number of neutralizing antibodies.

"How," he asked, "do we get it to a sufficient number in the very specific points of entry for the HIV virus in a mucosal tissue? It seems to be insurmountable. It might take up to 30 or 40 more years. My view is that therapeutic vaccines could function as a potential starting point for developing a preventative vaccine as well."

Despite a positive reception from the public health community --not only doctors and scientists, but also educators, social workers, government workers and activists -- there are still many social, political, and scientific obstacles to overcome before a therapeutic vaccine can be available to the public. For example, there is a decreasing urgency surrounding the issue of HIV/AIDS due to improving treatment options antiretroviral drugs.

"I think a sense of urgency has somewhat disappeared from the issue of HIV/AIDS because HIV is generally not a terminal illness, at least in the developed world," Rautsola said. "Sometimes it seems that there is even a sense of casualness about it. People have become complacent about it. They think, ’If I get the infection, then OK, I have a drug to deal with it.’ But there are consequences to the drug therapies, even though it is not lethal as it was in the 1980s."

The currently available treatment options are more toxic and less efficacious in the fight against HIV/AIDS than therapeutic vaccines that are being developed by VIRxSYS. "Immunotherapy is different from anti-retroviral chemicals," Rautsola noted. "These pills are harmful for the body in the long-term. With a vaccine, the body itself may be able to deal with the virus. An already infected individual gets the vaccine and, with that, those infected individuals can control the infection so well that their bodies do not deteriorate into AIDS."

There are also social and political barriers to the distribution and impact of therapeutic vaccines such as continued discrimination, marginalized and uneducated communities, and lack of government funding.

Rautsola pointed out that HIV/AIDS is actually a growing problem for the heterosexual community, especially women of color and women in developing countries, although it remains at high risk in the gay world as well. The scientific community has more recently focused on the increasing rates of infection among American women and women living in Sub-Saharan Africa.
He also pointed out alarming rates of infection among Hispanic-American and African-American women. "Females in many societies have very little protection from misuse by men," he said. "Basically, females are being blamed by society as the transmitter of the disease, even though it is more often men that are causing its spread."

Rautsola helped form an organization called Call to Action that advocates the distribution of Nevirapine to African mothers and their children, which slows mother-to-child transmission to only 10 percent. "Through this program, we saved 11 million babies," he noted. "Today, we are dealing with a problem of almost half a continent being wiped out in its societal and economic progress."

A therapeutic vaccine could directly impact these communities by lowering the incidence of transmission within high-risk communities such as gay men and women of color. However, before this vaccine can save lives, a therapeutic vaccine must make it past clinical testing.

The vaccine in development by VIRxSYS has already been successfully tested on primates, now it must be tested on humans within ethical guidelines and also be approved by the U.S. Food and Drug Administration, which might prove problematic due to fears that the vaccine could cause dangerous, even cancerous, mutations.

VIRxSYS’ vaccine grew out of HIV cell therapy. The company is now ending pre-clinical and primate trials. "We believe we have a functional cure for the disease," Rautsola said. Some 40 percent of the vaccinated and tested primates became undetectable in their viral load, their immune systems were improved, and even the rest of the vaccinated primate group survived. All but one of the animals that did not get the vaccine died.

Getting Government Approval
The next step is human testing. If VIRxSYS can show similar results in a small population, there will be a second trial. If this is successful, the FDA could give conditional approval, which often happens with AIDS drugs because there is such a need for them.

Even if VIRxSYS or one of the other 15 companies can develop a functional cure for AIDS, government support and availability will impact people living with HIV/AIDS. As a founder of Accelerating Access -- five pharmaceutical companies formed to help provide access to drugs -- he knows first hand the problem. Accelerating Access helped reduce prices by 90 percent in developing countries, which was even lower than the generic drugs.

Of the total 36 million HIV infected individuals, 11 million should be on treatment, but only close to 4 million receive antiretroviral retreatment. "The issue today is not pricing anymore," Rautsola said. "The logistics are not there, because antiretroviral drugs are complicated to apply and use. This is not a sustainable solution. Seven to 10 years from today we will have to have a therapeutic vaccine. The logistic implication is more favorable. A person can get one vaccine regimen, possibly with periodic booster shots, which is more affordable and easier to achieve compliance."

Rautsola is also faced with the problem of receiving enough funding to continue his studies therapeutic vaccine research, as the majority of funds now go towards developing preventative vaccines. Most of the funding comes from government sources to cover the cost of HIV/AIDS, much of which is being paid by US taxpayers. Rautsola believes that "we should be looking more towards a therapeutic vaccine because that is the lower-hanging fruit."

"We are doing as much lobbying as we can in the Congress and the White House. Mr. Crowley [President Obama’s director HIV/AIDS Strategy] has shown a high interest in therapeutic vaccines. Also, NIH is doing a lot of work in AIDS, and we are working with them and other groups to raise awareness and other groups to raise awareness and achieve funding. It is about information and complications. HIV is not very high interest item for the capital market because there is a perception in society at large that the disease is ’curable’ with the current drugs."

Annie Brown grew up in Washington, DC and at present, does most of her journalism and activism work in Virginia. She has worked for independent publications in both the United States and India. Annie is currently a writer and sexual health educator in Richmond, Virginia.

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