By Scott Malone

BOSTON (Reuters) – General Electric Co is teaming up with U.S. biotech company Geron Corp to use stem cells to develop products that could give drug developers an early warning of whether new medicines are toxic.

The venture is the largest U.S. conglomerate’s most direct attempt to make a commercial products from human embryonic stem cells. Scientists say the cells hold great medical promise, but their use has been highly controversial in the United States.

Embryonic stem cells are the body’s master cells and can grow into various types of human tissue, such as skin or internal organs.

GE and Geron aim to use an existing batch of stem cells to develop sample human cells that drug companies could use to test the toxicity of new drugs early in the development process, before they are ready for animal testing or human clinical trials.

The venture would not sell actual stem cells, but rather heart or liver cells derived from stem cells, said Konstantin Fiedler, general manager of cell technologies at GE Healthcare.

“This could replace, to a large extent, animal trials,” Fiedler said in a telephone interview. “Once you have human cells and you can get them in a standardized way, like you get right now your lab rats in a standardized way, you can actually do those experiments on those cells.”

Fiedler emphasized the products are still in an early development stage. GE estimated it would have the first commercial cells ready next year.

Geron shares surged 15 percent after the news of its deal with the Fairfield, Connecticut-based company, which has made expanding its healthcare operation a major push this year.

POTENTIAL, CONTROVERSY

Scientists say that research on embryonic stem cells, which are the most malleable, has enormous potential to develop treatments for cancer and other diseases.

But using stem cells derived from days-old human embryos has been controversial in the United States, where opponents say the destruction of any embryo is wrong. The Obama administration in March lifted a Bush-era decision that had forbidden federally funded researchers to work with the embryonic cells.

GE’s stepping up its presence in stem cell research could boost the field’s standing, advocates said.

“What I read this to be is validation that human embryonic stem cell research is moving through the pipeline as it should be and what once were promising theoretical ideas are now getting closer and closer to being ideas in practice,” said Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, a group that advocates stem-cell research.

GE will fund the research and manufacturing and sell any resulting products, while Menlo Park, California-based Geron will open up to GE its extensive database covering the growth of and differentiation of existing human embryonic stem cells.

The companies did not disclose the financial terms of the arrangement. Fiedler said it was too early to estimate the revenue the project might generate.

Needham analyst Mark Monane, who follows Geron, wrote in a note to clients that the financial terms were likely “modest,” but added: “The value of the opportunity lies in the quality of the partner.”

In May, GE reached a deal with Cytori Therapeutics Inc to commercialize that company’s StemSource product.

GE has had since 2005 a policy to do research on stem cells, while following all U.S. and applicable laws, but had not tried to commercialize a product from them, Fiedler said.

Geron shares rose 98 cents to close at $7.67 on the Nasdaq, while GE closed down 4 cents at $11.72 on the New York Stock Exchange.

Smaller U.S. companies including StemCells Inc and Aastrom Biosciences Inc and Osiris Therapeutics Inc have focused on stem-cell research, although the technology has also caught the attention of drug giants such as No. 1 Pfizer Inc, which last year quietly launched a stem cell initiative.

(Reporting by Scott Malone in Boston, additional reporting by Esha Dey in Bangalore; Editing by Lisa Von Ahn and Andre Grenon and Carol Bishopric)

© Thomson Reuters 2009 All rights reserved

GENEVA (Reuters) – The first H1N1 infection found to be resistant to the antiviral Tamiflu represents an “isolated case” with “no public health implication” at this time, the World Health Organization (WHO) said Tuesday.

The United Nations agency has declared a global pandemic is underway from the virus known as swine flu which has so far been treatable with Roche’s Tamiflu.

WHO spokesman Dick Thompson said that the discovery of a patient in Denmark whose infection did not respond to the drug, revealed by the Swiss drug company and Danish officials on Monday, did not amplify the severity of the virus.

“This is an isolated case. At this time, there is no public health implication. But we must remain alert as the virus can change at any time and we must not be complacent,” he told Reuters. Officials say the patient is now well and no further contagion with the resistant virus was detected.

(Reporting by Stephanie Nebehay and Laura MacInnis)

© Thomson Reuters 2009 All rights reserved

LONDON (Reuters) – Having sex every day improves the quality of men’s sperm and is recommended for couples trying to conceive, according to new research.

Until now doctors have debated whether or not men should refrain from sex for a few days before attempting to conceive with their partner to improve the chance of pregnancy.

But a new study by Dr David Greening of Sydney IVF, an Australian center for infertility and in vitro fertilisation (IVF) treatment, suggests abstinence is not the right approach.

He studied 118 men with above-average sperm DNA damage and found the quality of their sperm increased significantly after they were told to ejaculate daily for seven days.

On average, their DNA fragmentation index — a measure of sperm damage — fell to 26 percent from 34 percent, Greening told the European Society of Human Reproduction and Embryology in Amsterdam on Tuesday.

Frequent sex does decrease semen volume but for most men this is not a problem.

“It seems safe to conclude that couples with relatively normal semen parameters should have sex daily for up to a week before the ovulation date,” he said in a statement.

“In the context of assisted reproduction, this simple treatment may assist in improving sperm quality and ultimately achieving a pregnancy.”

Greening said it was likely frequent ejaculation improved the quality of sperm by reducing the length of time they were exposed to potentially damaging molecules called reactive oxygen species in the testicular ducts.

(Reporting by Ben Hirschler, editing by Paul Casciato)

© Thomson Reuters 2009 All rights reserved

By Michael Perry

SYDNEY (Reuters) – Australian scientists have developed a “trojan horse” therapy to combat cancer, using a bacterially-derived nano cell to penetrate and disarm the cancer cell before a second nano cell kills it with chemotherapy drugs.

The “trojan horse” therapy has the potential to directly target cancer cells with chemotherapy, rather than the current treatment that sees chemotherapy drugs injected into a cancer patient and attacking both cancer and healthy cells.

Sydney scientists Dr Jennifer MacDiarmid and Dr Himanshu Brahmbhatt, who formed EnGenelC Pty Ltd in 2001, said they had achieved 100 percent survival in mice with human cancer cells by using the “trojan horse” therapy in the past two years.

The scientists plan to start human clinical trials in the coming months. Human trials of the cell delivery system will start next week at the Peter MacCullum Cancer Center at the Royal Melbourne Hospital and The Austin at the University of Melbourne.

The therapy, published in the latest Nature Biotechnology journal, sees mini-cells called EDVs (EnGenelC Delivery Vehicle) attach and enter the cancer cell.

The first wave of mini-cells release ribonucleic acid molecules, called siRNA, which switch off the production of proteins that make the cancer cell resistant to chemotherapy.

A second wave of EDV cells is then accepted by the cancer cell and releases chemotherapy drugs, killing the cancer cell.

“The beauty is that our EDVs operate like ‘Trojan Horses’ They arrive at the gates of the affected cells and are always allowed in,” said MacDiarmid.

“We are playing the rogue cells at their own game. They switch-on the gene to produce the protein to resist drugs, and we are switching-off the gene which, in turn, enables the drugs to enter.”

DISARMING TUMOUR CELLS

RNA interference, or RNAi, is designed to silence genes responsible for producing disease-causing proteins and is one of the hottest areas of biotechnology research. RNA was the basis of the 2006 Nobel Prize in medicine.

Dozens of biotechnology companies are looking for ways to manipulate RNA to block genes that produce disease-causing proteins involved in cancer, blindness or AIDS.

Brahmbhatt said that after treatment with conventional drug therapy, a large number of cancer cells die but a small percentage of the cells can produce proteins that make cancer cells resistant to chemotherapeutic drugs.

“Consequently, follow-up drug treatments can fail. The tumors thus become untreatable and continue to flourish, ultimately killing the patient,” said Brahmbhatt.

“We want to be part of moving toward a time when cancers can be managed as a chronic disease rather than being regarded as a death sentence,” he said.

The Nature report said the mini-cells were “well tolerated with no adverse side effects or deaths in any of the actively treated animals, despite repeated dosing.”

“Significantly, our methodology does not damage the normal cells and is applicable to a wide spectrum of solid cancer types,” said MacDiarmid.

“The hope is that the benign nature of this EDV technology should enable cancer sufferers to get on with their lives and operate normally using out-patient therapy.”

(Editing by Alex Richardson)

© Thomson Reuters 2009 All rights reserved

CHICAGO (Reuters) – A Colorado meat company is expanding a recall of beef due to possible contamination by E.coli O157:H7 bacteria after an investigation found 18 illnesses may be linked to the meat, the U.S. Agriculture Department said on Sunday.

Greeley, Colorado-based JBS-Swift Beef Co is voluntarily expanding its June 24 recall to include about 380,000 lbs of assorted beef products, USDA said. The original recall was for 41,280 lbs.

The affected beef was produced on April 21 and was distributed nationally and internationally.

E.coli O157:H7 is a potentially deadly bacteria that can cause bloody diarrhea, dehydration, and, in severe cases, kidney failure. The very young, seniors, and persons with weak immune systems are at the most risk.

Consumers with questions can call 1-800-685-6328.

JBS Swift is a unit of Brazilian meat company JBS S.A..

(Reporting by Bob Burgdorfer; editing by Mohammad Zargham)

© Thomson Reuters 2009 All rights reserved

By Donna Smith

WASHINGTON (Reuters) – President Barack Obama’s drive to overhaul the U.S. healthcare system may be back on track thanks to Senate efforts to cut the price tag to $1 trillion, but a bipartisan deal on the sweeping proposal still is far from certain.

Obama wants changes that rein in the escalating costs of healthcare in the United States and bring insurance to most of the 46 million Americans who currently lack it.

He also wants a bill that the Democrats who control Congress and the Republican minority can support to give a bipartisan stamp of approval to his top legislative priority.

Senate Finance Committee Chairman Max Baucus was upbeat last week after announcing that panel members had found ways to bring the price tag to about $1 trillion over 10 years, down from an earlier estimate of a staggering $1.6 trillion.

The new estimates helped move lawmakers closer to an agreement, Baucus said. But he was unable to close the deal with Republicans before senators left for a weeklong July 4 Independence Day holiday recess.

Instead, the core group of negotiators — three Democrats and four Republicans — issued a tepid statement on Thursday merely affirming their commitment to continue negotiations.

“As we have been for the last several weeks, we are committed to continuing our work toward a bipartisan bill that will lower costs and ensure quality, affordable care for every American,” said the group, which includes Baucus and Senator Charles Grassley, the top Republican on the panel.

Soaring healthcare costs undermine the competitiveness of U.S. businesses, strain state and federal budgets and drive many Americans into bankruptcy.

The United States has the world’s most expensive healthcare system. Americans get coverage either through private insurance provided by employers or bought by individuals, or through government-run programs for the elderly, poor and others.

But millions remain uninsured and the United States lags many other industrialized nations in important health measures such as life expectancy and infant mortality.

“VERY DELICATE PROCESS”

The Finance Committee is one of five in the Senate and House of Representatives working on healthcare legislation, and may represent the best chance of obtaining a bipartisan bill.

“It is a very delicate process that Senator Baucus is trying to engineer,” said Ron Pollack, executive director of the influential Families USA advocacy group.

A deal that includes Grassley would go a long way toward bringing other Republicans on board, he said.

But any compromises could end up alienating Democrats.

A group of liberal House Democrats put out a statement last week saying they would oppose any healthcare overhaul that did not include a “strong” new government-run insurance program to compete with private insurers. Proponents argue it is the only way to ensure affordable coverage.

Grassley and other Republicans oppose this “public option,” saying it would drive private insurers out of business and lead to a government-run health system. Grassley also has raised questions about a proposed compromise to create nonprofit insurance cooperatives to compete with private insurers.

Meanwhile several Senate Republicans, including Minority Leader Mitch McConnell, have been speaking out daily in opposition to Obama’s healthcare ideas. They are expected to continue the effort in July when Democratic leaders hope a bill will be ready for Senate consideration.

NOT CHEAP ENOUGH

Although not as costly as earlier estimates, Republicans say the $1 trillion cost is still too high at a time of huge federal budget deficits that could hit $1.8 trillion this year. They argue that the 10-year cost after the program is fully phased in is closer to $2.3 trillion.

The package likely will include some tax increases, also strongly opposed by Republicans.

The U.S. Chamber of Commerce, which represents 3 million U.S. businesses, has started a grass-roots campaign opposing major elements of Obama’s plan with thousands of business owners writing lawmakers to say they are against it.

At best, the healthcare measure may get a few Republican votes. Senator Richard Durbin, the Democrat in charge of vote counting in the Senate, said he needs at least three.

In theory, Democrats are just one vote shy of the 60 needed in the 100-member chamber to overcome procedural hurdles on controversial bills.

But Democrats are hampered by the fact that two of their oldest members, Senators Edward Kennedy and Robert Byrd, are gravely ill and have missed most of the votes this year. Also, the Minnesota Senate election, in which Democrat Al Franken has been declared the winner, remains unresolved in the courts.

(Editing by Will Dunham)

© Thomson Reuters 2009 All rights reserved

By Tan Ee Lyn

HONG KONG (Reuters) – Revelers across Asia who snort the animal tranquilizer ketamine for a hallucinogenic high may face incontinence and other health problems as new dangers of this cheap party drug start showing up in long-term studies.

Doctors in Hong Kong, where ketamine took off as a party drug about a decade ago, have recently found that heavy users have poor bladder control and are prone to long-term liver damage.

“The worst cases are in young people who have to empty their bladders every 15 minutes. They can’t even take a bus ride without alighting and going to the toilet,” said Ben Cheung, a psychiatrist who works with ketamine users.

“Their kidney functions are affected and they are so young. This is a serious health consequence that we never expected because it has never been seen anywhere else.”

Incontinence is not the only problem for these drug users, who sniff the powdery hallucinogenic that looks much like cocaine but costs 10 percent of the price.

A recent study in Hong Kong of 97 drug users, most of whom primarily took ketamine, found that over 60 percent of them suffered depression, 31 percent complained of poor concentration and 23 percent had memory problems.

“It shocked the users. Never did they think it would affect brain function and they care about that,” said Tatia Lee, who was a member of the team conducting the study.

Ketamine users usually mix the drug, synthesized in 1962 as an veterinary anesthetic, with other substances. To increase profits, dealers add powder from paint scraped off walls, chalk and crushed glass which gives the same shimmer of good quality ketamine.

“It’s difficult to pin certain effects to a drug but ketamine is still the primary substance,” Cheung said.

POOR MAN’S COCAINE

Odorless, cheap and easy to consume, ketamine, which started out as a poor man’s cocaine, edged out heroin in Hong Kong around 2000 and then overtook marijuana.

Hardcore addicts spend just HK$100 (US$13) daily for three hits of the drug.

Sources familiar with the trade say ketamine is widely manufactured in liquid form in China, and then brought into Hong Kong, where it can be easily converted into the powder form that is snorted by addicts.

Many young people in Hong Kong travel across the border to China to enjoy the party scene and a cheap and plentiful supply of ketamine. While not addictive, users become psychologically dependent, expert say.

In 2008, Hong Kong had an estimated 8,309 psychotropic drug users of which 5,042 used ketamine, according to one study. Methylamphetamine, or ice, is in second place with 1,360 users.

Together with other drugs such as ice and ecstasy, ketamine was used in regional rave party circuits in the yearly years of the decade, turning up in places such as Taiwan, Bangkok, Singapore and Malaysia.

“It has (also) spread beyond Asia to places like Canada, particularly its ethnic Chinese community. Drug trend is like fashion, it is passed along by friends,” said Cheung.

Although raids by anti-drug agencies in Hong Kong in recent years have driven ketamine away from nightspots, its abundant supply and ease of use has led to ever younger people becoming addicted and the drug being consumed just about anywhere.

“Its use is rising and we have addicts as young as nine. Before, people used it in nightspots, now drugs are a part of their lives, they use it everyday, in their homes, in their office (toilets), everywhere,” said Sparkle Yu, a social worker with Caritas, a Catholic help group in Hong Kong.

“It is very easy to buy. They (pushers) can deliver them to the foot of your office building in 15 minutes.”

Yet, as with all drugs, the consequences are dire.

“The complications of psychotropic drugs are many. For ice and ecstasy, they are linked to cardiac, lung and breathing difficulties, brain damage,” said Peggy Chu, senior medical officer and urologist at Tuen Mun Hospital in Hong Kong.

“For ketamine, there is long term neurological and uterine complications, like having to go to the toilet every 15 minutes, bladder, kidney and liver problems. Colangitis, or inflammation of the bile duct, causes stomach pain and it could damage the liver in the long term.”

(Editing by Megan Goldin)

© Thomson Reuters 2009 All rights reserved

By Ben Hirschler

LONDON (Reuters) – Sanofi-Aventis’s diabetes drug Lantus may increase the risk of cancer, according to European studies involving some 300,000 insulin-treated patients, prompting a call from experts for more research.

The European Association for the Study of Diabetes (EASD), which released details online of four studies from its journal Diabetologia, said they were “far from conclusive but they do indicate the need for further investigation of this issue.”

The new research was released after mounting speculation that damaging data was about to be published over a cancer link with Sanofi’s modern long-acting insulin analog, sinking the the French drugmaker’s share price by 12.3 percent in two days.

Lantus, which sold 2.45 billion euros (2.1 billion pounds) in 2008, is a key driver for Sanofi as top drugs like Plavix and Lovenox face the threat of generic competition. Analysts have been expecting sales to grow strongly for the next five years.

A German study of 127,031 diabetics on insulin found malignancies were more common in patients treated with Lantus, also known as glargine, than in those prescribed a comparable dose of old-style human insulin.

“Our analysis does not provide absolute proof that glargine promotes cancer,” said Peter Sawicki, director of Germany’s Institute for Quality and Efficiency in Health Care and co-author of the study.

“Our study does, however, arouse an urgent suspicion which should have consequences for the treatment of patients.”

Following that original German study — which was presented to the European diabetes journal last year — further research was carried out using three other large patient databases, or registries, in Sweden, Scotland and the UK.

In the Swedish study, involving 114,841 insulin-treated patients, those on Lantus alone were almost twice as likely to be diagnosed with breast cancer.

The 49,197-patient Scottish study also found patients on Lantus were more likely to have cancer, including breast cancer, although the difference did not reach statistical significance.

The UK study — the smallest of the four, involving 10,067 patients — found no link.

TREATMENT OPTIONS

The EASD said patients should not stop taking treatment but the organization added they could consider using a long-acting human insulin or a mixture of long- and short-acting human insulin twice a day instead of once-daily Lantus.

The EASD said it had already communicated the latest study results to the European Medicines Agency and had started discussions with Sanofi as to how further studies might be conducted to get to the bottom of the issue.

“A large combined analysis of the best available databases worldwide is the best way forward,” EASD president Ulf Smith said in a statement.

He added there was no evidence that Lantus actually causes cancer, but it might possibly cause any existing cancer cells to grow and divide more rapidly.

Sanofi said late on Friday it had just been made aware of the latest data and it stood by the safety profile of Lantus, given the extensive evidence from past clinical trials and post-marketing surveillance.

Tim Anderson, an analyst with Sanford Bernstein, said the new research was not alarmist, but it would still likely have a negative impact on Lantus demand.

“As the core driver of Sanofi-Aventis’ earnings going forward, this will probably continue to weigh on the stock,” he said.

Denmark’s Novo Nordisk also has a long-acting insulin analog called Levemir, which is modified in a different way from Lantus. Levemir was launched more recently, however, so was not assessed in the European registry studies.

For an earlier analysis on Lantus, click on

(Editing by Sue Thomas)

© Thomson Reuters 2009 All rights reserved

By Julie Steenhuysen

CHICAGO (Reuters) – More than 1 million people in the United States may have been infected with the new H1N1 swine flu, U.S. health officials said on Friday, and infections continue to rise.

The new H1N1 influenza virus that has triggered a global pandemic is infecting people in the United States well beyond the normal period for influenza season, Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention told reporters in a telephone briefing.

“The key point is this new infectious disease is not going away,” Schuchat said. “In the U.S., we’re still experiencing a steady increase in the number of reported cases, with 6,000 new cases reported just this week.”

That represents the largest number of cases to be reported in a one-week span since the beginning of the outbreak in April.

The World Health Organization is now reporting more than 67,000 confirmed cases of H1N1 flu and some 300 deaths worldwide.

In the United States, there have been 27,717 laboratory-confirmed cases, including more than 3,000 hospitalizations and 127 deaths.

“We are estimating about a million people in the U.S. or more have gotten this virus at a time of year when people really aren’t continuing to get the seasonal influenza viruses,” Schuchat said.

“A big question that everybody really has is what kind of illness, hospitalization and deaths will we see when our winter flu season begins?”

‘NOVEL VACCINE’

Schuchat said vaccine makers are developing H1N1 vaccine that will be tested in clinical trials over the summer.

She said the CDC has not yet decided if it will recommend people get the new shots when flu season in arrives in North America in the fall. But Schuchat said the CDC is asking state and local health departments to draw up plans for how to handle distribution of the vaccines.

“We want states to be ready to offer and administer this novel vaccine,” she said, focusing especially on how to reach younger people, pregnant women and people with underlying health conditions like asthma and diabetes that put them at higher risk.

At a three-day meeting in Atlanta of the Advisory Committee on Immunization Practices, which advises the U.S. Centers for Disease Control and Prevention, CDC researchers said one vaccination scenario could include as many as 600 million doses.

That could place a heavy burden on cash-strapped health departments, which would likely have to distribute two doses of the new vaccine, which might be required for full immunity, in addition to the regular seasonal flu vaccination program.

Schuchat said the CDC continues to watch for changes in the virus in the Southern Hemisphere, where flu season is now in full swing.

“We have not seen any changes in the virus that are important at this point,” she said.

In the United States, the new flu continues to spread, with 12 states reporting widespread flu activity, something Schuchat said was “very unusual for this time of year.”

“That is just one feature that helps us to see that what we are seeing is quite different,” she said.

She said flu infections are even affecting children attending camps in the Northern Hemisphere summer, with outbreaks in 34 camps in 16 states.

“Some have actually closed for the summer.”

(Editing by Xavier Briand)

© Thomson Reuters 2009 All rights reserved

CHICAGO (Reuters) – A new understanding of the genes that make muscle cells may change the way researchers think about stem cell transplants for muscular dystrophy and muscle injuries, U.S. researchers said on Wednesday.

In a surprise finding, they said genes important for forming muscle cells in embryos and newborns are not normally active in adult stem cells.

And researchers hoping to use muscle stem cells in stem-cell transplant therapies should not assume genes that control early muscle development serve the same purpose in repairing adult muscle, Christoph Lepper and colleagues at the Carnegie Institution in Baltimore reported in the journal Nature.

Earlier studies have shown that two genes — Pax3 and Pax7 — control cells that give rise muscle in embryos, and Pax7 also helps build muscle in newborn mice.

To get a better understanding of their function, Lepper and colleagues studied these genes at various stages of development in live mice.

“I thought that if they are so important in the embryo, they must be important for adult muscle stem cells,” Lepper said in a statement.

The team used genetic engineering to suppress both the Pax3 and Pax7 genes in adult muscle stem cells, and they found that adult stem cells were still able to function normally.

“I was totally surprised to find that the muscle stem cells are normal without them,” Lepper said.

The researchers then looked at whether the same was true in injured muscles, when muscle stem cells go to work making new muscle tissue.

To study this, they injured mouse leg muscles between the knee and ankle, and found the muscle stem cells were able to make new muscle, even without the two key embryonic muscle stem cell genes.

The team said the embryonic muscle cell genes appear to only be active in mice within the first three weeks after birth. After that, they believe the genes go quiet and allow a different set of genes to take over.

Finding those genes will be important as scientists pursue new treatments for diseases like muscular dystrophy, a genetic, degenerative disease that affects voluntary muscles, they said.

And they said teams should look at other types of stem cells to see how age might affect their properties, and they should take age of stem cells into account in transplant-based treatments.

(Reporting by Julie Steenhuysen, editing by Jackie Frank)

© Thomson Reuters 2009 All rights reserved

Latest news, analysis’ and background information on the outbreak of swine flu spreading across the world.  Full Coverage