Alzheimer's Treatment Shows Promise in Small, 3-Year Trial

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Four-in-one AIDS drug gets the OK in clinical trial

Four-in-one AIDS drug gets the …

An experimental once-daily pill that combines four drugs to fight HIV is as safe and effective as commonly-prescribed treatments against the AIDS virus, researchers reported in The Lancet Friday.

Doctors tested the new drug, called Quad, for the third and final phase in which new pharmaceutical products are vetted for safety and effectiveness.

Publication in the British journal follows a recommendation in May by a US Food and Drug Administration (FDA) advisory panel to approve Quad for previously untreated adults infected with HIV-1. A final decision is expected by August.

The first trial entailed testing Quad against a three-in-one pill, Atripla, which since 2006 has been a standard treatment for the human immunodeficiency virus (HIV).

Researchers enrolled 700 patients in centres in North America and assigned them randomly to either Quad or Atripla.

After 48 weeks of treatment, 88 percent of Quad patients had suppressed viral loads to below detectable levels, against 84 percent in the Atripla group.

Side effects were infrequent but similar in both groups. Among Quad patients, mild nausea was the more common adverse event, whereas with Atripla, symptoms were likelier to be dizziness, abnormal dreams or insomnia and skin rashes.

In the second trial, 708 patients were enrolled in Australia, Europe, North America and Europe.

Patients were either given Quad or a widely recommended therapy comprising the molecules atazanavir (ATV), boosted by ritonavir (RTV), together with emtricitabine (FTC) and tenofovir disoproxil fumarate, or TDF.

After 48 weeks, 90 percent of the Quad group had viral levels below detectable levels compared to 87 percent in the other drug group.

Only 3.7 percent of patients in the Quad group stopped treatment because of side effects, compared with 5.1 percent in the other group. On the other hand, the number who reported kidney complications in the Quad group was relatively higher.

Quad comprises FTC and TDF, along with a drug called elvitegravir (ETV), which is designed to inhibit HIV replication. The fourth ingredient is a "pharmacoenhancer" called cobicistat to boost the effectiveness of ETV.

The movement towards a single once-daily pill to suppress HIV has a huge benefit for patients, say AIDS researchers.

When the first antiretroviral drugs emerged in the 1990s, patients had to take a dozen tablets a day or more, a "pill burden" that meant many forgot to follow the entire treatment.

"Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant," said Paul Sax of Harvard Medical School, who led the first study in Friday's Lancet.

"Our results provide an additional highly potent, well-tolerated treatment option, and highlight the simplicity of treatment resulting from combining several antiretrovirals in single pill."

Quad is made by the US pharmaceutical giant Gilead Sciences, which also funded the trials, a practice that is relatively common in drug development.

Clinical tests for new drugs have to go through a three-phase process that is scrutinised by independent assessors and government regulators for safety and objectivity. Publication of the research in a peer-reviewed journal is a final step in the procedure.

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Peregrine soars as cancer drug meets trial goal

Reuters – 1 hr 31 mins ago (Reuters) - Peregrine Pharmaceuticals Inc said results from a mid-stage trial showed that its key experimental drug performed better than standard chemotherapy in lung cancer patients who had not responded to primary therapy, sending its shares up 36 percent.

Peregrine tested two doses of its drug, bavituximab, along with standard chemotherapy treatment as a second-line treatment in 112 non small-cell lung cancer patients.

These results come two months after data from another study showed that bavituximab did not fare significantly better than a placebo when used as a first-line treatment for non small-cell lung cancer.

Peregrine's shares, which have fallen 35 percent since the first-line trial data was announced in March, were up 18 percent at $0.51 on Monday.

In the second-line treatment study, both doses met the secondary goal of stopping cancer progression for more than 4 months, compared with 3 months for those treated with a combination of the standard therapy and a placebo, Peregrine said in a statement.

"We are impressed by the strong clinical data for the primary overall response rates endpoint as well as the current indications of a survival benefit," Roth Capital analyst Joseph Pantginis said in a note.

Peregrine is also testing bavituximab as a treatment for pancreatic cancer. However, the company is targeting a much bigger market with non small-cell lung cancer.

Non small-cell is the most common type of lung cancer. The American Cancer Society estimates lung cancer claims the lives of more than 160,000 people every year, representing about 28 percent of all cancer deaths.

The analyst said the positive results could potentially move partnering discussions to the next level and expects Peregrine to discuss the study details with U.S. health regulators in the second half of the year.

Pantginis, who had cut his price target on the stock twice since the frontline study, raised it to $5 from $3.30 and said bavituximab has a broad therapeutic potential.

The drug did not show any significant safety issues when compared with the standard therapy in the study, Peregrine said.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Roshni Menon)

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French trial opens in diabetes-diet drug scandal

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New Zealand firm to trial pig cells to treat Parkinson's

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Stem-Cell Trial Failed to Treat Heart Failure

HealthDay – 15 hrs ago SATURDAY, March 24 (HealthDay News) -- An innovative approach using patients' own bone marrow cells to treat chronic heart failure came up short in terms of effectiveness, researchers report.

Use of stem cell therapy to repair the slow, steady damage done to heart muscle and improve heart function is safe, but has not been shown to improve most measures of heart function, the study authors said.

"For the measures we paid most attention to, we saw no effect, there is no question about that," said researcher Dr. Lemuel Moye, a professor of biostatistics at the University of Texas School of Public Health in Houston.

"Ultimately, this is going to pay off handsomely for individuals and for public health in general, but it's going to take years of work," Moye said. "We are the vanguard looking for new promising lines of research."

While the hoped-for results didn't materialize, there appeared to be a small improvement in some patients, he said. "When we looked at another commonly used measure of heart function called ejection fraction, or the strength of the heart's pumping, that's where all the action was," Moye noted.

It's hard to know which measures of heart function to look at, Moye explained. "We have had some difficulty with that," he said.

Future research will look at other measures of heart function, pay more attention to the characteristics of the cells that are injected and determine which cells are best, he added.

Cardiac cells and other types of specially prepared cells are available now that were not accessible when this study started in 2009, Moye pointed out.

The results of the trial, which was sponsored by the U.S. National Heart, Lung, and Blood Institute, were to be presented Saturday at the American College of Cardiology's annual meeting in Chicago. The report was also published online March 24 in the Journal of the American Medical Association.

For the study, Moye and colleagues worked with 92 patients, average age 63 and mostly male, who had heart failure with and without chest pain. They were randomly assigned to receive either an injection of 100 million bone marrow cells from their own bone marrow, or an inactive placebo. Patients in both groups also received aggressive medical therapy.

During the trial, the researchers looked for improvements in blood volume in the heart, oxygen use by the heart and blood flow through the heart.

After six months, the researchers said they saw no difference between the groups in these measures. Nor was any difference seen in the extent of heart damage, heart movement during contractions or overall condition.

Moye's team did find a slight improvement in the heart's ability to pump blood among patients 62 and younger. The improvement was small, only 3.1 percent, but patients in the placebo group declined 1.6 percent in this measure, they said.

It's possible that cells of younger people are more potent, and that's borne out by improvement in heart function seen in younger patients who did not get bone marrow cells, Moye said.

"We have demonstrated that the characteristics of the cells are correlated with heart function, so that the better the cells, the better the response -- so even in patients who did not get stem cells, those younger patients did better," he said.

Commenting on the study, Dr. Gregg Fonarow, director of the Ahmanson-University of California, Los Angeles, Cardiomyopathy Center, said there has been "tremendous interest in cell-based therapies" to treat acute and chronic heart disease and chronic heart failure.

Most studies trying delivery of different types of cells have been small and not adequately powered to demonstrate improvement in cardiac function or clinical outcomes, and results have been mixed, Fonarow said.

"While this study failed to meet any of its primary or secondary endpoints, the insights provided will be helpful in designing future trials," Fonarow added. "However, whether cell-based therapies will be of therapeutic value to patients with heart disease and heart failure remains to be seen."

More information

For more information on heart disease, visit the American Heart Association.

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