Tag Archives: Clinical trial

Fighting Fire with Fire.. How HIV is Used to Cure Cancer!

When all conventional forms of treatment were exhausted, Emma Whitehead, 6, was entered into a clinical trial where she was injected with a disabled form of the HIV virus to reprogram her immune system and genetically kill cancer cells.

The result, as seen in the video, exceeded all expectations. Emma is now in remission and her progress is being tracked everyday.

If you never thought you’d see the day when you’d appreciate HIV . . .

Researchers at the University of Pennsylvania were looking for a way to stop tumor cell growth, or actively kill the tumor cells. They had several patients (adults with chronic lymphocytic leukenia) and kids with acute lymphoblastic leukemia. These patients had failed all previous standard chemotherapy treatments and would all have probably died in less than a 1 month.

Researchers at Penn had developed a technique to modify the patients’ own T-cells to turn them into what they called “serial killer” cells. These serial killer T-cells could each kill approximately 1000 tumor cells that had the CD-19 antigen on them. This antigen is found on the malignant lymphocytes in these leukemia patients.

To produce the serial killers, researchers needed to modify the patients’ own T-cells by genetically engineering them to produce an antibody-like protein that would sic them on the tumor cells. To do that, the researchers needed to get at the T-cells’ genes. They found that the best way to get this process to work was to use HIV.

The HIV naturally seeks out T-cells and binds to them, then injects its own genetic material, functionally taking over the cell. Forcing it to produce millions of copies of HIV before the cell dies. The researchers modified the HIV so that it could no longer cause the infected cells to produce HIV. But it was programmed to cause them to produce the protein that would make them highly specific serial killers.

The researchers removed T-cells from each patient, cultured them, added the specially programmed HIV. They let the HIV inject and modify the cells, removed them and infused them into the patients. The results? The modified T-cells were very effective. In one case, the modified T-cells destroyed an estimated two POUNDS of tumor.

12 patients who participated in this small trial (10 adults and 2 children). Nine patients responded and all are still alive, some after almost three years. They show no evidence of any remaining leukemic cells and are generally doing well.

The research received additional grant funding and is continuing. The possibility exists that, using modified HIV, other tumor antigens can be successfully targeted and similarly destroyed.

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HIV research offers hope

Issue 89 - Scaling up treatment guidelines in resource limited settings

Immediate treatment of HIV can slow the progression of the virus, a study undertaken by researchers from the University of Oxford, Imperial College London and the Medical Research Council’s Clinical Trials Unit has shown.

Antiretroviral medication taken during the early stages of infection, over a 48-week period, delays damage to the immune system and can defer the need for long-term treatment.

An estimated 34 million people suffer from HIV worldwide. The virus weakens the immune system, leaving the body vulnerable to infection. In its early stages it often goes unnoticed; left unchecked, it can result in individuals being in danger of life-threatening illnesses.

The study, which took place over five years, took the form of a randomised controlled trial of antiretroviral treatment on 366 adults from Australia, Brazil, Ireland, Italy, South Africa, Spain, Uganda and the UK. It comprised mostly of heterosexual women and gay men and was funded by the Wellcome Trust.

At present, it is unusual for antiretroviral medication to be given to HIV patients in the early stages of infection. The trial randomly allocated the volunteers, who had been diagnosed with HIV no more than six months earlier, medication for 48 weeks, 12 weeks or not at all.

On average, the study found that those receiving no medication required a lifelong course of treatment 157 weeks after infection. Those receiving 12 weeks of antiretroviral medication took an average of 184 weeks before receiving lifelong treatment. Participants on the 48 week course began long-term treatment on average 222 weeks after infection.

Moreover, those receiving medication for 48 weeks had higher CD4 T-cell counts, which can reduce susceptibility to secondary infections such as tuberculosis. Adults on this course recorded lower levels of HIV in the blood, which could help reduce the risk of infection for sexual partners.

Dr Sarah Fidler, leader of the study from Imperial College London said: “These results are very promising and suggest that a year-long course of treatment for people recently infected with HIV may have some benefit on both the immune system as well as helping control the virus.”

Concerns over how cost-effective such treatment would be have been raised by some who do not deem the findings to be tremendously significant. Professor Gita Ramjee, who led the study in South Africa, commented: “We now need to weigh up whether the benefits offered by early intervention are outweighed by the strategic and financial challenges such a change in policy would incur, particularly in resource-poor settings such as Africa, although this may be where the most benefits are seen in terms of TB rates.”

Students at Oxford University have expressed interest in this new study. Fergus Chadwick, a Biologist, said: “It is really fascinating to see how theory that has been outlined in our lectures is being applied in the real world with such promising results.”

Original Article by Elizabeth Pugh at Oxfordstudent.com

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Farewell Spencer

spencercox

Spencer Cox, one of the world’s most prominent AIDS activists and a highly respected “citizen scientist” has passed away.

Spencer Cox, the pivotal AIDS activist who co-founded ACT-UP and TAG (Treatment Action Group) and was featured in David France’s recent documentary How to Survive a Plague, has died at Columbia Presbyterian of AIDS related causes, France writes in a note:

 As a very young man fresh from Bennington, where he studied Theater and English Literature, he arrived in NYC after finishing just 3 years. He was diagnosed with HIV soon thereafter. By 1989, at age 20, he had become spokesman for ACT UP during its zenith through the early 90s. A member of its renowned Treatment & Data committee, and later co-founder of TAG (the Treatment Action Group), he schooled himself in the basic science of AIDS and became something of an expert, a “citizen scientist” whose ideas were sought by working scientists. In the end, Spencer wrote the drug trial protocol which TAG proposed for testing the promising protease inhibitor drugs in 1995. Adopted by industry, it helped develop rapid and reliable answers about the power of those drugs, and led to their quick approval by the FDA.

Even before ACT UP, he began work for amfAR (Foundation for AIDS Research), first as a college intern, eventually going on staff as assistant to Director of Public Affairs, responsible for communications and policy).  He left there to co-found the Community Research Initiative on AIDS (now the AIDS Community Research Initiative of America, ACRIA) with Dr. Joseph Sonnabend and Marisa Cardinale (Marisa Cardinale <marisacard@aol.com>). At ACRIA, he ran public affairs and edited all publications.

From 1994 to 1999, he was Director of the HIV Project for TAG, where he did his ground breaking work in drug trials designs. He designed the drug trial adopted in part by Abbott as they were developing Norvir, the first Protease Inhibitor to head into human trials. It had an “open standard-of-care arm,” allowing people on the control arm to take any other anti-AIDS drugs their doctors prescribed, versus the arm taking any other anti-AIDS drugs plus Norvir. It was this study that showed a 50% drop in mortality in 6 months. Norvir was approved in late 1995. Though the results were positive, the proposal sharply divided the community, many of whom thought it was cruel to withhold Norvir on the control arm. Spencer defended himself in a controversial BARON’S coverstory that made him, briefly, the most-hated AIDS activist in America. Ultimately he was vindicated.

Writing for Poz in 2006, Cox wrote:

“Some of my friends lived for almost 20 years through a flood of death, illness, fear and sadness. And when effective treatment came along and the dying slowed—at least in much of the developed world—everyone assumed that things had gotten better, that we didn’t need to think about it anymore.  But I don’t think that’s true. I think those of us who were in the middle of it were deeply affected by what we experienced and that it affects the choices we make today. I wonder if that’s not partly why the depression rate among gay men is about three times higher than among straight men.

“Because of my memories of those times, I try to appreciate life and the people special to me. But I can also see that I have to fight off an ongoing fear that things could go suddenly, terribly wrong, that the worst-case scenario is also the most likely.”

“What I learned from that is that miracles are possible. Miracles happen, and I wouldn’t trade that for anything. I wouldn’t trade that information for anything. I don’t know what’s going to happen. I don’t know what’d going to happen day to day. I don’t know what’s going to happen next year. I just now, you keep going. You keep evolving and you keep progressing, you keep hoping until you die. Which is going to happen someday. You live your life as meaningful as you can make it. You live it and don’t be afraid of who is going to like you or are you being appropriate. You worry about being kind. You worry about being generous. And if it’s not about that what the hell’s it about?”

Farewell Spencer, and thank you for all your hard and contribution

Spencer

Spencer Cox
1968 – 2012

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Information about the effort and influence surrounding HIV/AIDS prominent activists is available here.

Cuba Will Start Clinical Human Trials of a Vaccine Against HIV This Year.

The announcement was confirmed by the director of clinical research of Cuba’s genetic engineering and biotechnology centre, Dr Verena Muizo, at the International Biotech Conference-Havana 2012.

“In terms of the vaccine against the human immunodeficiency virus (HIV), it should start soon,” he said.

“We hope in the second quarter of this year, or in the third. It is a clinical study of individuals infected with the human immunodeficiency virus, but it is a phase one study, for safety, and to start to try this possible vaccine.

Dr Muizo said the vaccine, known as TERAVAC-VIH-1, would start as a small study in just a few patients.  “The clinical study that we are going to do is going to be done with a small number of patients, 30.

“These are individuals that have not reached the Aids stage but are instead in the seropositive stage without reaching the clinical Aids stage.”
A seropositive patient tests positive for HIV antibodies, but still has an immune system strong enough to fight off opportunistic infections that can cause complications with patients with full-blown Aids. (sic)

The researchers working on the HIV vaccine, though hopeful, were quick to point out that the investigation is still in the early phases and they will not know for many years whether the vaccine is effective or not.

“The vaccine is starting its clinical evaluation and we hope it works.
“But really, we need a lot more time to really be able to show its effectiveness as a product,” Dr Muizo added.

In December last year a group of Canadian scientists won approval to start testing an experimental vaccine on humans. Developed by researchers from the University of Western Ontario, it received a green light from the US Food and Drug Administration.

Original article via Sky News

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This 90 Percent Successful Vaccine May Be Our Best Chance to Eradicate HIV/AIDS

Dr Esteban

Spanish researchers have completed the first human trial of a new vaccine against HIV. It has been successful in 90% of the HIV-free volunteers during phase I testing. This vaccine brings great hope to eradicate HIV forever.

The team lead by Dr Mariano Esteban, a researcher at the Spanish National Research Council‘s Biotechnology National Centre, has been working on this method since 1999. They are using an attenuated virus called the MVA-B, a variation of the Modified Ankara Vaccinia, which was previously used to eradicate smallpox. The Modified Ankara Vaccinia also forms the base of other vaccines. The B refers to the HIV-B, the most common HIV subtype in Europe.

Dr Esteban’s team inserted the HIV genes Gag, Pol, Nef and Env in MVA’s genetic sequence. In 2008, they tried the resulting HIV nuke on mice and monkeys. It was a complete success.

SUCCESSFUL HUMAN TEST

The first human test results were published in Vaccine and Journal of Virology. In the experiment, scientists injected the vaccine in 24 of 30 HIV-free volunteers. Six volunteers were treated with a placebo vaccine—they didn’t experience any effect. But 90% of the treated subjects developed a very strong immunological response against the HIV virus. 85% kept the immunological reaction for at least one year, which is really good news.

According to their results, there were no significant secondary effects in any of the patients, which was one of the major objectives of to be tested in this clinical trial.

Despite the success, Dr Esteban is cautious:

“The treatment has only been tested on 30 volunteers and, while the vaccine provokes a powerful response in most of the cases, it’s still to soon if the resulting defense would be effective against an actual HIV infection”.

The team will now start another phase I trial, injecting the vaccine in HIV-infected people. The objective of this trial is to test the therapeutical effect of the vaccine in these patients.

According to Dr Esteban, “in principle, the immunological profile of MVA-B satisfies the requirements for a promising vaccine against the HIV, like the creation of antibodies and the activation of key cells in the defense against the virus.” Sadly, it is still far away from commercialization: they need to test this on phase II and III trials, injecting vaccinated volunteers with the actual HIV virus on a larger scale.

Hopefully, one day, this vaccine will nail the HIV nemesis down.

Original Article by Jesus Diaz at Gizmodo

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Genetically Modified Tobacco Plants [Podcast]

Science Weekly is a regular weekly podcast from The Guardian which covers all the latest developments in the world of science and how it can be applied in today’s world.

We posted an article last month about antiviral drugs manufactured using genetically modified tobacco.  In the most recent episode of Science Weekly, Alok Jha meets Professor Julian Ma, the  molecular immunologist who is investigating whether genetically modified tobacco plants can be used to produce anti-HIV drugs.

Professor Ma and his team at St George’s Hospital Medical School in London have just received the green light in Europe to carry out a clinical trial of the antibody produced by his plants.

It’s available to listen to below, however you may wish to visit their page or subscribe to their podcast.

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