Monkey study could lead to ‘functional’ HIV cure

Data was so dramatic: Fauci ‘Psilocybin shows very impressive results’

CHICAGO, Dec 1, (RTRS): Dr Anthony Fauci doesn’t get too excited about the results of animal studies, and he doesn’t make house calls.

But when a drug already taken by thousands of people for intestinal conditions appeared to control the monkey version of HIV, it got the attention of the director of the National Institutes of Allergy and Infectious Diseases.

Fauci hopped on a plane to Cambridge, Mass, to personally tell Japan’s Takeda Pharmaceutical Co’s US representatives that their drug may offer a dramatic advance in the fight against AIDS.

Takeda’s drug suppressed the the virus to undetectable levels in eight monkeys, some for two years. The findings raise hopes for a socalled “functional cure” - a treatment that puts the disease in sustained remission.

“The data was so dramatic,” said Fauci, who has made AIDS research his life’s work.

The drug is one of several promising ideas heading into early-stage human trials, all seeking to help patients control the virus that causes AIDS for extended periods without daily antiretroviral therapy (ART).

The studies build on research propelled by the case of Timothy Ray Brown, the so-called “Berlin patient,” whose HIV was eradicated through an elaborate stem cell transplant in 2007.

“There has been this explosion of discovery,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition. “There are completely new ideas that were impossible to conceive even a few years ago.”

Suppresses

HIV once meant certain death. But, for more than half of the 36.7 million HIV patients around the world, ART transformed it into a chronic disease.

Taken daily, ART suppresses the virus. But keeping up a daily medication regimen is diffiAd26/MVA NEW YORK, Dec 1, (AP): The psychedelic drug in “magic mushrooms” can quickly and effectively help treat anxiety and depression in cancer patients, an effect that may last for months, two small studies show.

It worked for Dinah Bazer, who endured a terrifying hallucination that rid her of the fear that her ovarian cancer would return. And for Estalyn Walcoff, who says the drug experience led her to begin a comforting spiritual journey.

The work released Thursday is preliminary and experts say more definitive research must be done on the effects of the substance, called psilocybin (sih-loh-SY’bihn).

But the record so far shows “very impressive results,” said Dr. Craig Blinderman, who directs the adult palliative care service at the Columbia University Medical Center/ New York-Presbyterian Hospital. He didn’t participate in the work.

Psilocybin, also called shrooms, purple passion and little smoke, comes from certain kinds of mushrooms. It is illegal in the US, and if the federal government approves

cult. The drugs are expensive and toxic, causing nausea, fatigue and nerve problems in the shortterm, and insulin resistance and other problems over time.

Only about a third of US patients take ART consistently enough to push the virus down to undetectable levels.

“We’re going to need other approaches,” said Dr Nelson Michael, director of the US Military

the treatment, it would be administered in clinics by specially trained staff, experts say.

Nobody should try it on their own, which would be risky, said the leaders of the two studies, Dr. Stephen Ross of New York University and Roland Griffiths of Johns Hopkins University in Baltimore.

Psychedelic drugs have looked promising in the past for treating distress in cancer patients. But studies of medical use of psychedelics stopped in the early 1970s after a regulatory crackdown on the drugs, following their widespread recreational use. It has slowly resumed in recent years.

Griffiths said it’s not clear whether psilocybin would work outside of cancer patients, although he suspects it might work in people facing other terminal conditions. Plans are also underway to study it in depression that resists standard treatment, he said.

The new studies, published in the Journal of Psychotherapy, are small. The NYU project, which also included psychotherapy, covered just 29 patients. The Hopkins study

HIV Research Program at the Walter Reed Army Institute.

Much work has focused on the discovery of rare antibodies made by HIV patients that can neutralize several different forms of the virus. One trial involving an antibody called PGT121 licensed by Gilead Sciences Inc reduced the virus to undetectable levels in 16 of 18 monkeys; the effect lasted for four months in three

had 51.

Bazer, who lives in New York, was diagnosed with ovarian cancer in 2010, when she was 63. Treatment was successful, but then she became anxious about it coming back.

“I just began to be filled with a terrible dread,” she said in an interview. “You’re waiting for the other shoe to drop . ... (The anxiety) was ruining my life.”

She swallowed a capsule of psilocybin in 2012 in the company of two staff members trained to guide her through the several hours that the drug would affect her brain. As she listened to music through headphones, her eyes covered with a sleep mask, the drug went to work.

“Suddenly I was in a dark, terrifying place, lost in space, lost in time,” she recalled. “I had no bearings and I was really, really terrified.”

Then she felt deep love for her family and friends, and sensed their love for her. “It felt like I was bathed in God’s love ... I’m still an atheist, by the way, but that really seemed to be the only way to describe it.”

of them.

At Walter Reed, Michael is taking a different tack, testing whether a vaccine - being developed to prevent HIV infection - can fight off the virus in infected individuals.

Last month, Michael and researchers at Harvard’s Beth Israel Deaconess Medical Center published the results of a monkey test of Johnson & Johnson’s HIV vaccine candidate called and Gilead’s experimental drug GS-986.

On its own, the vaccine had a modest effect. But it was even more effective when it was given with GS-986, a so-called TLR-7 agonist that “kicks the immune system up to a higher gear,” Michael said.

All nine monkeys that got both treatments showed significantly reduced viral loads. In three, the combination therapy has kept the virus at bay for at least six months.

Human trials could begin within months, said Dr Paul Stoffels, J&J’s chief scientific officer.

“If the cure is there, the industry will find a way to get there very quickly,” Stoffels said.

Focused

Fauci’s visit was a first for Takeda, a company focused on treatments for cancer, gastroenterology and the central nervous system, said Dr Michael Shetzline, who heads clinical science for Takeda in Cambridge.

“The excitement was just clear,” Shetzline said. “It was like, ‘Wow.’”

Takeda does not study HIV. But its researchers understood the basic science surrounding its drug Entyvio, an antibody engineered to attack a specific protein.

The drug, known generically as vedolizumab, is approved in more than 50 countries for ulcerative colitis and Crohn’s disease, which occur when the immune system attacks the intestines.

“Entyvio is a cell trafficking molecule that affects immune responses,” Shetzline said. “In this instance, the GI tract is what is harboring this HIV cell population that needs to be cleared - at least that is what the monkey study implies.”

Takeda is providing the drug and supporting the study. Shetzline cautioned that it’s only a pilot.