Texas delays action on stem cell therapy rules

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AUSTIN, Texas (AP) — The Texas State Medical Board voted Friday to delay until next year final approval of new stem cell therapy rules that could restrict — or even block — procedures such as the one Gov. Rick Perry recently underwent on his aching back.

Its 19 members, including a dozen physicians, voiced support for greater oversight but opted to tweak the proposed rules and take them up again at their next meeting in February. If the reworked rules are satisfactory, formal approval could come as early as April.

The Food and Drug Administration hasn't approved using adult stem cells to help people heal from surgery, but experimentation is common. Some scientists tout the possible benefits, including treatment for heart disease, diabetes, and some cancers. Others argue adult stem cell experimentation actually increases the risk of cancer and can cause blood clots.

Perry, 61, a Republican presidential candidate, had stem cells taken from fat in his own body that were then grown in a lab. They were injected into his back and his bloodstream during an operation in July to fuse part of his spine.

The proposed rules would require an independent panel to conduct a comprehensive safety review of any procedure involving stem cells before it is carried out. Without that review, procedures such as the one Perry underwent would not be allowed.

Some noted that new stem cell regulations could have unintended consequences, however, such as limiting the ability of tissue banks to collect genetic material for transplants. As a result, the board asked its staff to modify the rules.

"My sense is, this 80, 85 percent ready for primetime and they're just adding some material," said Leigh Hopper, a board spokeswoman.

Perry, who appoints the board, sent it a letter in July saying he appreciated the responsibility to protect patients. But he also urged members to "recognize the sound science and good work that is already being done, and will continue to be done in the future, in this field."

"We need to ensure that physicians in this state can continue to pursue new technologies and treatments that will benefit all Texans," Perry wrote. "Texas is a leader in innovation in many fields. It is critical that we continue to foster an environment that encourages technological advancement in the health care arena."

Following his surgery, Perry has worn a back brace but maintained his hectic campaign schedule — though he has begun wearing orthopedic shoes, foregoing his trademark cowboy boots. Adult stem cell therapy is different from using embryonic cells, a controversial technology that the governor opposes.

Lucy Nashed, a spokeswoman for the governor, said Friday that he "expects the Texas Medical Board to review all the facts and make the appropriate decision regarding the use of this promising technology in Texas."

At least 10 states — including California, Illinois and New York — have enacted rules governing stem cell research, according to the Interstate Alliance on Stem Cell Research.

The impetus for Texas' proposed rules did not grow out of Perry's procedure but did involve the physician who performed it, Dr. Stanley Jones. The Houston-based orthopedist, who is Perry's doctor and friend, touted the benefits of stem cell therapies at the medical board's June meeting. He said many Americans pay thousands of dollars to undergo treatment abroad and that it is a shame that Texans can't access the treatment in their home state.

Perry also helped push an amendment to a larger health care bill through the Texas Legislature in June creating a state bank to store and cultivate adult stem cells for treatment purposes.

NBC reported in September that the first bank approved by the state — Celltex Therapeutics Corp. of Houston — is co-owned by Jones and David G. Eller, the former chairman of the board of Texas A&M University, and a top Perry donor.

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Gene therapy 'to protect sight'

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27 October 2011 Last updated at 16:08 GMT By Pallab Ghosh Science correspondent, BBC News Jonathan Wyatt: Hoping doctors can save his sight so he can continue to work as a lawyer Researchers in Oxford have treated a man with an advanced gene therapy technique to prevent him from losing his sight.

It is the first time that anyone has tried to correct a genetic defect in the light-sensing cells that line the back of the eye.

The president of the Academy of Medical Sciences said the widespread use of gene therapy of this treatment will be soon be possible.

The operation was carried out on 63-year-old Jonathan Wyatt, an arbitration lawyer based in Bristol.

Mr Wyatt was able to see normally until about the age of 19 when he began having problems seeing in the dark.

He was told by doctors that his vision would get progressively worse and he would eventually go blind.

The gradual deterioration in his vision didn't stop Mr Wyatt from qualifying as a barrister. But 10 years ago he found he was having difficulty reading statements in dimly-lit courts.

"The worst occasion was when I was reading out a statement to the court and I made a mistake. The judge turned to me and snapped 'Can't you read Mr Wyatt?!' I then decided it was time to put my wig down and leave advocacy."

Geneticist Dan Lipinski, from the University of Oxford, explains the gene therapy process

Mr Wyatt is able to see well enough to work from home and hopes that the operation will enable him to continue his profession.

Without treatment he would be blind within a few years and would be unable to work in the way that he is doing so now.

"I'd like things to get a little better," he says.

Devastating diagnosis

Mr Wyatt suffers from a rare genetic disorder known as Choroideraemia.

These patients start off life with normal vision and its not until their late childhood that they notice that they cannot see anything at night and usually the diagnosis is made during middle to late childhood.

From then it is a devastating diagnosis because these young people are told that they are gradually going to lose their sight completely, usually by the time they are in their 40s. There is no treatment for this condition.

The disease is caused by an inherited faulty gene, called REP1. Without a functioning copy of the gene, the light detecting cells in the eye die.

The idea behind the gene therapy is simple: stop the cells from dying by injecting working copies of the gene into them.

It is the first time that anyone has attempted to correct a gene defect in the light-sensing cells that line the back of the eye.

Mr Wyatt is the first of 12 patients undergoing this experimental technique over the next two years at the John Radcliffe Hospital in Oxford.

His doctor, Prof Robert MacLaren, believes that he'll know for sure whether the degeneration in Mr Wyatt's eye has stopped within two years. If that's the case his vision will be saved indefinitely.

"If this works with then we would want to go in and treat patients at a much earlier stage in childhood, effectively where they still have normal vision and can do normal things to prevent them from losing sight.

Prof MacLaren believes that if this gene therapy works it could be used to treat a wide variety of eye disorders, including the most common form of blindness in the elderly, macular degeneration.

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I have no personal doubt in future that there will be a genetic treatment for macular degeneration”

End Quote Prof Robert Maclaren John Radcliffe Hospital, Oxford "That is a genetic disease and I have no personal doubt in future that there will be a genetic treatment for it," he says.

The Oxford research follows on from a gene therapy trial which began four years ago at Moorfields Hospital in London. The principle aim of these trials was to demonstrate that the technique was safe.

The treatment, which adopted a slightly different approach, was tested first in adult patients whose sight was almost gone, and then in children.

According to Prof Robin Ali, who led that research, the trials have shown not only that gene therapy is safe - but that there has been significant improvement in some patients.

"It is very exciting to see the start of another ocular gene therapy trial and the field moving so rapidly in recent years," he said.

"In the last 12 months, several new gene therapy trials for the treatment of various retinal disorders have been initiated and further trials are likely to start very soon. We are all looking forward to seeing the results."

Hype

The concept of using gene therapy for treating a whole host of conditions has been around for more than 20 years. But with, some notable exceptions, it's an idea that's failed to live up to its hype.

Now, however, it seems that the technique is beginning to deliver, at least in treating sight disorders.

According to Prof Sir John Bell, president of the Academy of Medical Sciences, these very early trails in Oxford, London and in the US suggest that a whole host of sight disorders could, be treatable "within the next 10 years".

"Of all the things that are available for this particular set of diseases this is by far the most exciting," he said.

"This is a set of diseases where molecular medicine has reached a point where we can now intervene in a very precise way to correct the defect that caused the blindness in the first place. There is the possibility that you could actually correct the gene defect."

The trial, led by Oxford University, has been jointly funded by the Wellcome Trust and Department of Health. It is an example of a new approach to medical research which brings together scientists and clinicians to translate basic science into effective treatments more quickly

"This is exactly where the NHS ought to be putting its effort and it's a perfect example of the benefits that might from using the NHS for this kind of research activity," said Prof Bell.

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FDA approves Merck's new diabetes therapy combo

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By Alina Selyukh

Fri Oct 7, 2011 1:23pm EDT

n">(Reuters) - U.S. health regulators approved a new combination therapy for type 2 diabetes from Merck & Co, the first to combine a diabetes drug with cholesterol-lowering medicine in one tablet.

Merck's new drug Juvisync combines the drugmaker's diabetes medicine Januvia, which helps lower high blood sugar levels, with simvastatin, a commonly prescribed statin that helps lower cholesterol alongside diet and exercise.

About 20 million Americans have type 2 diabetes, and many of them also have high cholesterol levels. The conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, especially if left untreated or poorly treated, the Food and Drug Association said.

For Merck, this is a chance to boost sales of Januvia, generically known as sitagliptin, whose sales rose 30 percent to $779 million in the second quarter.

The American Diabetes Association guidelines recommend statin therapy for anyone who has both diabetes and cardiovascular disease, regardless of cholesterol levels. They also recommend statins for anyone older than 40 with diabetes and with cardiovascular disease risk factors, such as high blood pressure.

Merck's experts have estimated that 6 million to 8 million of the type 2 diabetics who should be on a statin have not been receiving that therapy -- a gap that the company hopes to fill with the single-tablet Juvisync.

"Although clinical guidelines put people with diabetes at the same risk level as those with coronary heart disease, nearly 40 percent of eligible patients do not receive statin treatment," Dr. Barry Goldstein, Merck's vice president for diabetes and endocrinology, said in a statement. "We are proud to bring forward a treatment option that can help address this important health issue."

The FDA on Friday approved the combination in several dosage strengths.

The most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation and nausea, regulators said.

Merck will now have to conduct a post-marketing clinical trial to compare how Januvia lowers glucose alone compared to its combination with simvastatin, the FDA said.

Merck's shares were up 1.5 percent at $31.88 in afternoon trading on the New York Stock Exchange.

Approved in 2006, Januvia was the first FDA-backed member of a new class of drugs called DPP-4 inhibitors that enhance the body's ability to lower elevated blood sugar. It has previously been coupled with another diabetes drug, metformin, and sold under the brand name Janumet. Merck's second-quarter sales of Janumet reached $321 million.

(Reporting by Alina Selyukh in Washington; additional reporting by Ransdell Pierson in New York and Anna Yukhananov in Washington; editing by John Wallace and Matthew Lewis)

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Breast cancer study shows benefits of double therapy

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A woman undergoes a mammography exam, a special type of X-ray of the breasts, which is used to detect tumours as part of a regular cancer prevention medical check-up at a clinic in Nice, south eastern France January 4, 2008.

Credit: Reuters/Eric Gaillard

By Kate Kelland

STOCKHOLM | Sat Sep 24, 2011 6:04pm EDT

STOCKHOLM (Reuters) - Giving breast cancer patients radiotherapy and chemotherapy at the same time significantly cuts the risk their tumors will come back and should be considered as a new treatment approach across the world, cancer experts said on Sunday.

The double treatment, known as synchronous chemoradiation, could also save lives among people with breast cancer, a disease that currently kills 425,000 women a year worldwide, according to the British experts who conducted a major scientific study.

They said the synchronous treatment, which the study showed has limited side effects and does not harm patients' quality of life, should be considered for use by all breast cancer doctors.

"The results have implications worldwide," Indrajit Fernando, a consultant clinical oncologist at the University Hospitals Birmingham Trust, told reporters at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm.

"Clinical practice needs to be reviewed."

Breast cancer is the most common cancer among women. A recent study by the Institute for Health Metrics and Evaluation in the United States found that in 2010 it killed around 425,000 people and was newly diagnosed in 1.6 million.

Radiotherapy and chemotherapy are usually given after breast cancer surgery to kill any remaining cancer cells in the breast, chest wall or underarm area, and to try to reduce the risk of a local cancer recurrence. The standard approach is to give chemotherapy first, followed by radiotherapy.

But the best timings for radiotherapy and chemotherapy have long been debated among cancer experts, so Fernando's team decided to study various schedules of radiotherapy with a type of chemotherapy called anthracycline-CMF chemotherapy in patients with early-stage breast cancer.

The study involved almost 2,300 women in Britain who had already undergone surgery to remove their tumors.

The results showed that compared with the standard approach, giving both treatments at the same time "reduces the risk of local cancer recurrence by 35 percent in women with early breast cancer," Fernando said.

After a follow-up of over eight years, the study found that only 41 patients in the synchronous chemoradiation group had suffered recurrence, compared with 63 patients in the group who had standard chemotherapy followed by radiation treatment.

At five years, tumors had recurred in only 2.8 percent of those who got both treatments at the same time, compared with 5.1 percent among those who received the therapies separately.

Although there were no differences in overall survival rates between the two groups after five years, Fernando said he would expect to see survival rates rise in larger groups of patients over a longer time period.

"Even a 2.3 percent reduction in local recurrence rates will have an impact worldwide when we consider that this is a very common cancer," he said, citing data showing that for every four local recurrences of the disease prevented, one death from breast cancer death can be avoided.

Fernando said he has already changed practice in his own clinic and will send his data to Britain's National Institute of Clinical Excellence, which advises on treatment guidelines.

Michael Baumann, president of the European Cancer Organization, said more follow up would be needed to assess potential longer-term side effects. "I am convinced this trial will spur a lot of discussion," he said.

(Editing by Ruth Pitchford)

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Garden therapy could aid dementia

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20 September 2011 Last updated at 06:14 GMT By Huw Williams BBC Scotland reporter Donald Stewart picks beans at the Potager Garden Dementia patients across the country may be spending 24 hours a day locked in hospital wards - an unacceptable regime even for convicted prisoners.

And there is concern too many people with dementia are kept under a chemical cosh - powerful drugs used to control behaviour.

But now growing numbers of experts say access to the outdoors, and physical activity such as gardening, could transform life for patients with conditions such as Alzheimer's or dementia.

Donald Stewart, 79, was diagnosed with Alzheimer's five years ago.

His wife raised the alarm when he was becoming more and more forgetful.

When a psychiatrist sent him for a brain scan, it confirmed he had the condition.

He has been gardening at the Potager Garden - a community garden in Kinross - for more than a year.

His wife, Catherine, says it has been a "god-send".

When Donald comes to the garden, she says, he "feels wanted and necessary".

She says: "He's done some woodwork painting, and things like that. Quite well, I believe."

Annie Pollock is a landscape designer and expert on gardening for dementia patients.

Annie Pollock, landscape designer from the Dementia Services Development Centre at Stirling University, says it should not be surprising that core skills from Mr Stewart's lifetime of gardening remain, even as the disease takes away other aspects of his personality.

And she says there is plenty of evidence of the benefits outdoor activity such as gardening can have for people like him.

Ms Pollock says: "If you've got somebody being locked up for 24 hours a day - as seems to happen in some scenarios - they are going to be unhappy.

"They will present challenging behaviour. They probably won't sleep at night. They'll be frailer, and they will cost the system a lot more money to care for."

She adds: "Whereas people who are outside and active still can maintain an active interest in their environment, and their cognitive abilities decline slower."

'Powerful addition'

But Fiona Thackeray, from Trellis, a charity promoting therapeutic gardening which is organising a course on designing gardens for people with dementia, cautions that unlocking the garden gate does not necessarily mean you can keep the drugs cabinet closed.

She says: "We wouldn't argue that gardening is going to cure you, or take away all need for any other interventions.

"But it can be a really powerful addition, or complementary therapy, to any drug regime.

The Potager is a community garden in Kinross

"It's a great physical activity so it's a good way to keep fit, or get fitter. Most people find it calms them down, it's a great stress reliever."

Ms Thackeray adds: "More and more we're seeing the importance of vitamin D.

"Although we don't have much sunlight in Scotland, if you're outdoors in the garden you're going to be boosting your vitamin D levels."

And, she says the sense of smell is a really strong trigger for memory.

Ms Thackeray says: "So what better place than a garden, with all the scented flowers and herbs, for people with dementia? It can help them think back to their past, and bring back positive memories."

Donald Stewart laughs as he says he likes going to the garden.

"It passes away the time", he says. "Gets you out of the house now again again, like."

He and his wife leave the garden with bags full of blackberries, beans, beetroot, and apples. The fruits of Donald's labours.

Catherine Stewart says a bramble and apple pie is "next on the agenda".

But the long-term benefits for Donald's health may be much more valuable - if rather harder to quantify.

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Sangamo gene therapy shows promise in reducing HIV

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By Deena Beasley

Sun Sep 18, 2011 1:18pm EDT

n">(Reuters) - An early stage trial of Sangamo BioSciences Inc's HIV treatment found that the gene therapy reduced levels of the virus and even eliminated it in one patient with a naturally occurring gene mutation.

The very small Phase 1 trial tested the SB-728-T gene therapy, which is designed to disrupt the CCR5 gene used by HIV to infect cells of the immune system.

If shown to be safe and effective, the treatment could end the need for the antiretroviral drugs now used to keep the virus that causes AIDS in check by suppressing viral replication in the blood.

Trial results presented in Chicago on Sunday at the Interscience Conference on Antimicrobial Agents and Chemotherapy show a "statistically significant relationship between estimated modification of both copies of the CCR5 gene and viral load," said Dr. Carl June, trial investigator and director of translational research at the University of Pennsylvania's cancer research institute.

In a statement, June said the results suggest the need to increase the frequency of the modified cells in HIV-infected patients, which could lead to a "functional cure" for AIDS, but the means of achieving this have not been clarified.

Sangamo said earlier this year that a single infusion of the treatment improved immune system damage in nearly all of the subjects analyzed in the first trial of the therapy in humans.

The 10 patients in the trial were on antiretroviral therapy when the study began. After four weeks, six of them went on a "treatment interruption," during which they stopped taking antiviral medication for 12 weeks.

Viral load decreased in three of the six subjects, with one patient's viral load reduced to undetectable levels. That patient carried a naturally occurring mutation in one copy of his CCR5 gene.

Humans contain two copies of each gene, one from the father and one from the mother, which sometimes are referred to as the alleles of a gene.

"Since one copy of his gene was already disrupted naturally, twice as many of his cells were 'biallelically' modified," Sangamo Chief Executive Officer Edward Lanphier said in a telephone interview, meaning that both members of the CCR5 gene pair were knocked out.

He estimated that between 5 percent and 10 percent of HIV patients carry the genetic mutation.

Around 33 million people worldwide have the human immunodeficiency virus (HIV) that causes AIDS. Major producers of current HIV drugs include Gilead Sciences and GlaxoSmithKline.

Lanphier said Sangamo will move ahead with a strategy to maximize the number of cells that can be "biallelically" modified by SB-728-T. Options include targeting only the small segment of patients with mutated CCR5 genes or using "strategies that boost the amount of engraftment of modified cells."

The CEO said he plans to unveil details of Sangamo's plans at an investment banking conference in New York on Wednesday.

Lanphier emphasized that the company intends to take the HIV treatment into mid-stage trials without a partner.

"We have more than sufficient cash to push forward into Phase 2 trials," he said, reaffirming that Sangamo expects to have cash holdings of at least $85 million at year-end.

(Reporting by Deena Beasley in Los Angeles)

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HEALTH MANAGEMENT. New facility offers a potentially safer alternative gene therapy delivery

Spontaneous order of DNA fragments in a special matrix is the key to gene vectors, create treatment non-toxic delivery that recently in European physical according to a study, journal E.
Scientists of the CNRS Paul Pascal Research Centre, an Institute of the University of Bordeaux in France, and colleagues from the Institute of physics created a complex system, the University of Sao Paolo, which for this designed to keep DNA fragments in solution between the hydrophilic layers of a matrix of fatty substances (also, lipids) along with certain of the surfactant (used to reduce the levels of stiffness). Gene therapy is a possible application so far still not tested.
Although gene therapy was initially delivered using viral vectors, the recent attempts to develop of alternative vectors have with positively charged lipids form complex structures with DNA fragments taken advantage of electrostatic forces. However the positively charged ions that have used known as cations, in this type of vector for human cells has proven reliable.
Until now only positively charged fatty substance were suitable DNA in a complex vector operation. The authors of this study have opposite demonstrated by creating an electrically neutral matrix, like a layered cake, the DNA fragments in a high concentration in the solution between the layers built up.
The authors found that organize DNA fragments within the complex in the course of time. These fragments to align spontaneously parallel to each other and form rectangular and hexagonal structures across the Plains. The emergence of ordered structures in high concentrations in DNA explains the change of atomic level interactions within the levels and the representation of interactions at the interface between the layers and of DNA molecules.
The next step of the research are the exact physical forces that hold together the plant research. Applications of go gene therapy vector design, how you can apply the same principle for the supply of other particles such as chemical drugs.

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