FDA approves new kidney cancer drug

The U.S. Food and Drug Administration gave its approval to a new drug called Torisel (temsirolimus) for treating renal cell carcinoma, a type of advanced kidney cancer.

The approval of the drug, an enzyme inhibitor made by Wyeth Pharmaceuticals, was based on a study that showed use of the drug prolonged survival of patients with renal cell carcinoma. The study results were first presented last June at the American Society of Clinical Oncology annual meeting in Atlanta. And they were just published in the May 31 issue of the New England Journal of Medicine.

"We have made significant advances in the battle against kidney cancer," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "Torisel is the third drug approved for this indication in the past 18 months, and one that shows an increased time in survival for some patients."

The approval of Torisel follows the December 2005 approval of Nexavar (sorafenib), which was based on a delay in progression of disease. In January 2006, Sutent (sunitinib) received accelerated approval based on durable response rate, or tumor size reduction, and was later demonstrated to delay tumor progression.

The phase III, randomized clinical study of Torisel included 626 patients who received one of three treatments: temsirolimus; an older drug called interferon; or both drugs together. Patients who received temsirolimus alone survived longer (a median of 10.9 months) than those who received interferon/temsirolimus (8.4 months), or interferon alone (7.3 months).

"This is the first study to show that a new drug can improve overall survival for patients with metastatic renal cell cancer," said Dr. Gary R. Hudes, the lead author of the NEJM study, in a prepared statement.

Hudes, director of the Genitourinary Malignancies Program at Fox Chase Cancer Center in Philadelphia, said patients who received the combination treatment received a lower dose of temsirolimus than those who received temsirolimus alone. This could explain why those who received the combination treatment did not survive as long as those who received temsirolimus alone.

Many patients with kidney cancer are cured by surgery to remove the tumor. However, about 35 percent of patients will experience cancer recurrence or their cancer will spread to other parts of the body.

"For these patients, the goal of treatment is to prevent further spread and growth of the cancer, and ideally, to reduce that amount of cancer," Hudes said. "Until recently, physicians lacked effective drugs to control the disease."

He noted that this study found that temsirolimus provided modest improvement in survival for patients with the most advanced tumors.

"It would be reasonable to hypothesize that temsirolimus could provide greater benefit to patients with less extensive metastatic disease. Only a randomized clinical trial will give us that definitive knowledge," Hudes said.

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Weight loss pill not magic bullet

You won't lose weight in your sleep or shed pounds while eating anything you want - that's the sobering message from the maker of a weight loss pill poised to hit shelves next month.

GlaxoSmithKline last week opened an educational exhibit in New York City to prepare the country for alli, the first over-the-counter diet pill approved by the Food and Drug Administration.

While the cautionary marketing approach may not trigger stampedes to the counter, analysts say the drug's fate hinges on the pharmaceutical giant's ability to convince people diet pills aren't a magic bullet.

"People's hopes are ridiculously high when it comes to diet pills. That leads to disappointment and bad word of mouth," said Steven Brozak, an analyst with WBB Securities.

That's just what happened to the prescription version of the drug, Xenical by Roche Holding, which contains twice the dosage. People were let down when it failed to deliver dramatic results and the drug never really caught on, Brozak said.

GlaxoSmithKline has apparently learned the lesson and is counting on alli to become a star money-maker. The company is spending $150 million on marketing alli this year, making it one of the drug maker's biggest campaigns to date.

"We've done everything to go out of our way to be honest," said Steve Burton, vice-president of the weight control division at GlaxoSmithKline Consumer Healthcare. "We're taking a very different approach than the fad diets people are constantly exposed to".

In clinical trials, the FDA says people using alli lost an additional two to three pounds for every five pounds lost through diet and exercise. The FDA approved alli to be sold over the counter in February.

When taken with meals, the drug blocks the absorption of about one-quarter of any fat consumed.

That fat - about 150 to 200 calories worth - is passed out of the body, potentially resulting in loose stools.

About half of patients in trials experienced gastrointestinal side effects, including leakages and oily discharges.

GlaxoSmithKline is frank about those unpleasant effects, which it says can be controlled if the drug is used properly.

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Drug eluting nanostructured coatings enable targeted drug therapy for orthopedic patients

Drug delivery systems have progressed from the teaspoon to time-release capsules to drug-eluting stents.

Nanotechnology promises yet another advance by delivering therapeutic agents at desired rates exactly where needed in the body.

In a paper presented at the NSTI Nanotech 2007 Conference, researchers at the University of California, San Francisco demonstrate how they have created nanotubes from biocompatible metal oxides that can hold therapeutic proteins or drugs and deliver these agents in a highly-controlled manner.

The fabrication strategies developed by the authors is flexible in terms of controlling the diameter and length scales of the tubes. By changing these physical parameters of nanotubes, they could precisely control the dosage and deliver drugs at physiological rates for desired duration of time.

In the case of orthopedic implants with nanotubes on the implant surfaces, drugs such as antibiotics can be loaded in the tubes and released right at the site of implantation. This method, which targets the drug where it is needed, can avoid the side effects due to high dosages normally given to patients. Further, in cases where a very long treatment regimen is needed, such as in growth factor therapy, nanotubes may provide superior performance.

According to Ketul C. Popat, "When a person has an orthopedic implant surgery, they normally will have to take antibiotics and growth factors either orally or by injection. There are several side effects associated with taking drugs this way which can be very painful for the patient.

However, by placing the drugs on to the surface of these implants, we can deliver them right where they are needed and can avoid larger doses and side effects. The nanostructured coating on the implant surface helps the drug to maintain its bioavailability as well as deliver the drugs at physiological rates for a desired duration of time."

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Aspirin may cut pregnancy complication risk

Women at high risk for the pregnancy complication preeclampsia can lower their odds by 10 percent by taking daily aspirin, a new study suggests.

Preeclampsia is a potentially fatal obstetric complication that can lead to sudden high blood pressure and irregular blood flow. This can activate platelets and the clotting system, which in turn slows blood flow.

The use of aspirin may help counter this effect, according to a report in the May 16 online issue of The Lancet.

"Preeclampsia complicates between about 2 and 8 percent of all pregnancies, and is associated with approximately 10 to 15 percent of the half-million maternal deaths [worldwide] that occur each year," said lead researcher Lisa Askie, a research fellow in the School of Public Health at the University of Sydney, Australia.

Although the benefits of antiplatelet therapy such as daily aspirin are modest, they are important if given to women at risk of preeclampsia, Askie said. "They could potentially result in many thousands less women who experience a bad pregnancy outcome. Hence, particularly for women at high risk of preeclampsia, a more widespread use of antiplatelet agents may be worthwhile," she said.

In the study, Askie and colleagues in the Perinatal Antiplatelet Review of International Studies (PARIS) group looked at the results of 31 preeclampsia prevention trials that included almost 33,000 women and their babies. Women who took aspirin in these trials typically took between 50 milligrams to 150 milligrams of the drug per day.

The researchers found the risks of developing preeclampsia dropped 10 percent among women taking aspirin or other antiplatelet medications. In addition, these women also had a lower risk of delivering before 34 weeks and of having other pregnancy problems.

Moreover, aspirin had no significant effect on the risk of death of the fetus or baby. It didn't boost the risk of bleeding for either mothers or their infants, nor did it raise risks for underweight newborns.

Askie's team said no particular group of women was more or less likely to benefit from aspirin.
"Women at risk of preeclampsia should discuss the potential benefits and harms of this treatment with their doctor," Askie advised.

But one expert was less than impressed with the findings.

"The results of this study were, to a large extent, disappointing," said Dr. James Roberts, the director of the Magee-Womens Research Institute at the University of Pittsburgh, and author of an accompanying editorial.

Roberts had hoped the study would have shown a larger protective effect -- especially in the women who are at the greatest risk for the problem. "It's difficult to determine if it's more beneficial in any subset of women or at what dose," he said.

"In very high-risk women, the use of aspirin is justified," Roberts said. Women who are at the highest risk for preeclampsia are those who have high blood pressure and have also suffered preeclampsia in previous pregnancies. This group "are almost certain to develop it," he said.

Women at risk because of high blood pressure, pre-pregnancy diabetes or preeclampsia in one previous pregnancy have about a 20 percent risk of developing preeclampsia, Roberts noted.
"For these women, you would have to treat 50 with aspirin to prevent one case of preeclampsia," Roberts said.

"For a woman, whether benefits outweigh the risks is a decision that she has to work out with her doctor," he said.

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Breast tumour drug target found

A team from Canada's McGill University were able to block the action of an enzyme which fuels the growth of tumours, Nature Genetics reports.

They were able to delay cancer in mice with tumours which also respond to the drug Herceptin, but say other breast tumours may respond too.

UK experts said a new drug could boost the benefits of existing treatments.

Delay
The enzyme studied by the Montreal team was PTP1B, which appears to "remove the brakes" on cell division, fuelling tumour growth.

About 40% of human breast cancers have been shown to have excessively high levels of the enzyme.

The Canadian team studied a strain of mice prone to develop breast tumours because their HER-2 gene is overactive, as is the case for about a quarter of women with the cancer.
These are the women who benefit from the drug Herceptin.

The researchers found that deleting PTP1B in the mice led to a significant delay in the onset of breast tumours, and prevented the secondary development of tumours in the lungs.
Over-expression of PTP1B has already been implicated in the development of diabetes and obesity, where it shuts down insulin receptors, leading a number of drug companies to develop compounds to block its action.

The breast cancer researchers went on to give other mice a PTP1B-blocker developed by the company Merck.

This was also found to delay the development of breast tumours and prevent lung cancer.
The animals were treated for just two weeks, but the beneficial effects were seen for two months.

The researchers say that, because the mice studied were HER-2 positive, the study suggests that a combination of Herceptin and a PTP1B-blocker could benefit a significant number of women, although much more research is needed.

Other cancers
Professor Michel Tremblay, who led the work, said: "This study is very exciting for cancer patients.

"However it won't cure cancer alone. It's another tool to tackle cancers, perhaps particularly for HER-2 positive tumours.

"Combined with Herceptin, it may provide a 'two-way kill'."

Prof Tremblay said that, as other research had suggested a greater proportion of breast cancers had an over-expression of PTP1B than responded to Herceptin treatment, other women could also benefit.

In addition, other cancers including bone marrow tumours had also been shown to have too much PTP1B, indicating potential wider benefits.

Ed Yong, of Cancer Research UK, said: "Drugs that block PTP1B may be useful in treating the disease, but they will first need to be carefully tested in human clinical trials.

"Blocking PTP1B could boost the effects of existing drugs that work like Herceptin."

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Promising drug fails to improve COPD symptoms

A promising anti-inflammatory drug failed to improve symptoms of moderate to severe chronic obstructive pulmonary disease, or COPD, in a large, multi-center trial.

The results of the randomized, double-blind, placebo-controlled trial of infliximab were published in the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

According to an editorial commenting on the research, the failure of the infliximab to provide any therapeutic benefit in COPD patients was unexpected because the drug has proven effective in treating other inflammatory diseases, particularly rheumatoid arthritis and Crohn's disease.

COPD is the fourth-leading cause of death of men and women in the United States and the world. It is projected to become the third-leading cause of death, after heart disease and cancer, by 2015. Stephen I. Rennard, M.D., of the University of Nebraska Medical Center in Omaha, led a team of researchers at 41 U.S. medical centers that enrolled 234 subjects in the study.

Patients receiving infliximab were randomly selected to receive the drug in doses of 3 mg/kg or 5 mg/kg six times during a six-month period of time.


There were also no differences among the three groups in secondary efficacy endpoints as measured by FEV1, 6-minute walk distance, the transition dyspnea index and the number of exacerbations requiring a doctor or hospital visit.

According to the authors, the results of the study were surprising for a number of reasons. Infliximab is an anti-tumor necrosis factor TNF-á, and a number of studies have reported increased production of TNF in COPD patients. This increased production has been linked to weight loss, muscle weakness and muscle loss.

In addition, animal studies supported the prospect using the drug in COPD. When TNF-á was infused into rats, they developed emphysema, which, along with chronic bronchitis, makes up most COPD cases. When the TNF-á receptor was turned off in mice, they were less likely than mice that had not be genetically altered to develop emphysema when exposed to chronic cigarette smoke.

However, an increased number of malignancies observed in infliximab-treated subjects, the authors said, raised concern about the safety of this drug in lung patients. Although the malignancies may have been present when the patients enrolled in the study, "the possibility that infliximab contributed to the progession, and thus the diagnosis, of malignancies remains a serious concern."

This safety issue, coupled with the "resoundingly negative results," make in unlikely that a longer trial will be undertaken, according to the accompanying editorial.

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Vaccine may protect against CJD

Scientists say they have a vaccine that stops mice getting a brain disease similar to BSE in cattle and which may ultimately protect humans against vCJD.

Deadly prion diseases, like vCJD, are spread by consuming contaminated meat, and there is no cure or treatment.

A vaccine that decreases the spread of prion disease in animals would reduce the risk of spread in humans, says the New York University team.

It could also be considered for humans, they told a neurology meeting.

Brain disease
The diseases are caused by abnormal versions of prion proteins in the brain, which accumulate and cause brain damage, leading to dementia and abnormal limb movements.
As the infection takes hold, prion proteins invade brain tissue and force normal proteins to adopt their own misfolded shape.

Many research groups in the US and Europe are working on vaccines to block or avoid this process.

The prototype tested by Dr Thomas Wisniewski and his team was made from prion proteins attached to a genetically modified strain of a bug called Salmonella.

This bacterium is already used in a number of animal and human vaccines.

Trials
Many of the mice that received the oral vaccine had no symptoms of the disease after 400 days, while others had delayed disease onset.

Without the vaccine, it would normally take a mouse 120 days to develop the disease.
Dr Wisniewski said they were now in the process of redesigning the vaccine so it could be used on deer and cattle, and possibly humans, too.

He explained to the American Academy of Neurology: "If, for example, a more significant outbreak of chronic wasting disease in deer and elk occurs and if it were transmissible to humans, then we would need a vaccine like this to protect people in hunting areas.

"Or it could be given to delay disease in people with hereditary forms of prion disease or people who have been exposed to vCJD."

Professor David Brown, a prion disease expert at Bath University, UK, said: "These findings show that prion disease can be prevented and this is quite important.

"The major limitation of applying these findings to humans is that it remains impossible to tell who will develop CJD and who will not.

"If further work demonstrates that vaccination during early signs reverses symptoms, then it would be useable in treatment."

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Aspirin may increase stroke risk

Healthy older people who take regular aspirin to prevent stroke may actually be increasing their risk.

In the past 25 years the number of strokes associated with blood-thinning drugs such as aspirin or warfarin has risen seven-fold, a UK study found.

The risk is particularly high in the over 75s and aspirin may do more harm than good in healthy older people, The Lancet Neurology paper reported.

However, people advised to take daily aspirin by their GP should not stop.

Researchers at the University of Oxford compared figures on intracerebral haemorrhagic stroke - a type of stroke caused by bleeding in the brain - from 1981-85 and 2002-06.

They found that the number of strokes caused by high blood pressure had fallen by 65%, which in the under 75s meant the overall rate of strokes had halved. But in the over 75s the stroke rate remained the same over the 25-year period.

A closer look at the data showed there had been an increase in the number of strokes in patients taking blood thinning drugs, known as antithrombotics.

In the first study the proportion of stroke patients on antithrombotic drugs was 4% but two decades later this had risen to 40%.
Lifestyle choice

People with cardiovascular disease, who have a high risk of blood clot, are prescribed drugs like aspirin to thin the blood and reduce the risk of a heart attack or stroke.

But many healthy older people also take a regular aspirin in an attempt to ward off a stroke.
Study leader, Professor Peter Rothwell, said the increasing use of drugs such as aspirin may soon take over high blood pressure as the leading cause of intracerebral haemorrhagic stroke in the over 75s.

He warned than in healthy older adults the risks of taking aspirin may outweigh any benefits.

"GPs have been treating high blood pressure very aggressively and that is bringing dividends but there are other causes of stroke in the elderly which have become important.

"There are good reasons for taking aspirin or warfarin but there are elderly who take aspirin as a lifestyle choice and in that situation the trials have shown there's no benefit.

"And what our study suggests is that, particularly in the very elderly, the risks of aspirin outweigh the benefits," he said.

Dr Peter Coleman, deputy director of research and development for The Stroke Association said aspirin had gained a reputation of being part of a healthy lifestyle.

"However, this evidence indicates that if you are healthy and have a low risk of heart disease or stroke and unless advised by your GP to take aspirin on a daily basis then the increased risks from the side effects of aspirin are likely to outweigh the benefits of preventing a stroke."

He advised people to lower their risk of stroke by having regular blood pressure checks, eating a healthy diet, stopping smoking, only drinking alcohol in moderation, reducing salt intake and taking regular exercise.

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