Exercise boosts tumor-fighting ability of chemotherapy in cancer patients, researchers say

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 (Reuters)

While exercise has been found to benefit cancer patients both physically and psychologically, researchers say a new study proves it can also boost the effect chemotherapy has on a patient.

In a study by a team at the University of Pennsylvania, researchers using a mouse model of melanoma found that combining exercise with chemotherapy shrunk tumors more than chemotherapy alone.

The researchers sought to find whether exercise would protect against negative cardiac-related side effects of the cancer drug doxorubicin, which is known to damage heart cells.

The team first injected melanoma cells into four teams of mice. They then injected two groups with doxorubicin and the other two with a placebo. Over a two-week period mice in one of the groups injected with the drug and one of the untreated groups walked 45 minutes, five days a week, on treadmills, while the other two groups did not.

While data showed that exercise did not help protect against cardiovascular damage, it did show that in mice that had received the drug and exercised, tumors significantly shrunk.

“We looked, and the exercise didn’t do anything to the heart – it didn’t worsen it, it didn’t help it,” Joseph Libonati, senior author of the study and associate professor at Penn School of Nursing, said in a news release. “But the tumor data – I find them actually amazing.”

The team plans to examine further how exercise enhances the effect doxorubicin has on tumors, but are encouraged that results may help find ways to cut down on cardiovascular damage caused by the drug.

“If exercise helps in this way, you could potentially use a smaller dose of the drug and get fewer side effects,” Libonati said.

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Toxic jerky treats linked to more than 1,000 dog deaths

Toxic jerky treats linked to more than 1,000 dog deaths

Published May 19, 2014·
FoxNews.com

Reuters

More than 1,000 dog deaths may now be linked to toxic jerky treats, according to a recent update from the Food and Drug Administration (FDA).

The agency said that since 2007, there have been almost 5,000 complaints of pet illnesses related to the treats. The majority of the symptoms reported include gastrointestinal or liver disease, and about a third were linked to kidney and urinary disease.

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About 10 percent of the illnesses included other signs such as neurologic, dermatologic, and immunologic symptoms, and about 15 percent of the kidney and urinary disease cases also tested positive for Fanconi syndrome – a rare kidney disease also associated with the pet deaths.

The FDA is still unsure of the specific cause for the reported illnesses and deaths, but most cases reportedly occurred after the pets had eaten chicken, duck or sweet potato jerky treats imported from China. No specific brands were recalled in the FDA’s latest release, but Dr. Jonathan Levine, an associate veterinarian at Blue Pearl Veterinary Partners in New York City, said owners should always check the labels of whatever foods they give their pets.

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“Always be aware of what you’re buying and where it’s coming from,” Levine said.

Yet that may not always be enough to keep pets safe; products stamped “Made in the USA” could still contain ingredients sourced from China or other countries, the FDA warned.

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In 2007, some pet food companies voluntarily removed some jerky treats from the market. But, at the time, the FDA said it didn’t want to issue a recall without a definitive cause. Those products included Milo’s Kitchen Chicken Jerky Treats and Chicken Grillers, made by Del Monte, and Waggin’ Train and Canyon Creek Ranch dog treats, made by Nestle Purina.

The FDA has partnered with the Centers for Disease Control and Prevention (CDC) to figure out what foods may be contributing to pet disease. The study will compare the foods eaten by sick dogs to those eaten by dogs who haven’t gotten sick, in order to determine if the jerky is really the culprit.

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So far, testing of jerky pet treats from China revealed low levels of antibiotics as well as the antiviral drug amantadine in some chicken samples. Although FDA-approved for pain-control applications in humans and in dogs, the agency prohibited its use in poultry in 2006 to help preserve its effectiveness.

The FDA does not believe amantadine contributed to the illnesses, as the side effects of the drug do not correlate with the symptoms seen in the pets; however, amantadine should not be present at all in jerky treats.

Chinese authorities have agreed to conduct additional screenings and follow up with jerky treat manufacturers, and the FDA has notified U.S. treat makers of the presence of amantadine in some jerky products. The agency will also continue testing these products for drugs and other antivirals.

The FDA cautioned pet owners that jerky pet treats are not required for a balanced diet. If your pet experiences any sign of illness, including vomiting, diarrhea and lethargy, contact your veterinarian right away.

US drugmakers cheer ‘speed lane’ for breakthrough therapies

US drugmakers cheer ‘speed lane’ for breakthrough therapies

Smarter America

Published July 25, 2013

Reuters
  • Assorted Pills

A new regulatory pathway could shave years off the traditional drug approval process in the United States, according to some companies whose drugs have been given “breakthrough therapy” designation by the U.S. Food and Drug Administration.

Speaking at a briefing in Washington to raise awareness of the drug review process, Dr. Jay Siegel, head of global regulatory affairs at Johnson & Johnson, said he expects two years to be knocked off the time it would typically take the FDA to review ibrutinib, the company’s experimental cancer drug.

To be granted breakthrough designation, an experimental drug must show early indication of clinical improvement over existing therapies, even if the clinical trial is small. It might apply, for example, to a new type of cancer drug that shows strong early promise.

J&J’s ibrutinib, which it is developing with Pharmacyclics Inc, would be the first in a class of oral medicines that block a protein known as Bruton’s tyrosine kinase. It is being developed for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and for patients with mantle cell lymphoma, both cancers of the blood.

Dr. Jeffrey Leiden, the chief executive of Vertex Pharmaceuticals Inc, who also spoke at the briefing and whose cystic fibrosis drug Kalydeco was approved under the designation, said his company’s experience working with the FDA was dramatically different from the normal drug approval process.

Under breakthrough designation, he said, “everything is on the table” for discussion in order to move the process along as quickly as possible. Communications that might typically take weeks and months, under the breakthrough pathway take minutes.

“We pick up the phone and talk in real time,” Leiden said. “It makes the process immeasurably smoother.”

The breakthrough pathway was spearheaded by Friends of Cancer Research, a patient advocacy organization. It received bipartisan support in Congress and was signed into law in July 2012. As of July 12, the FDA had received 67 requests for breakthrough designation. It had granted 24 and denied 18.

Dr. Janet Woodcock, director of the FDA’s drugs division, said during the discussion that the breakthrough pathway was designed to accommodate new science, particularly targeted therapies that may work in people with certain genetic mutations. She noted that just because the review process is speeded up there is no guarantee of approval.

In the 1990s, she said, the agency was not seeing drugs whose promise could be detected in early clinical trials.

“We didn’t see these therapies in Phase I or II where you said ‘bingo,’ you’ve got a likely winner,” she said.

Still, there are challenges associated with speeding up a drug’s development timeline. For one thing, other nations might not be willing to approve the products based on the FDA’s more flexible clinical trial standards under the breakthrough designation.

“Our hope is that foreign regulators will catch up,” Siegel said.

Moreover, he said, it is not clear that insurers will pay for drugs if the data do not show improved survival or other clear benefit they are used to seeing when drugs are approved. One task, he said is to figure out “how to bring payors on board.”

The panelists did not discuss what happens once a drug reaches the market under the breakthrough designation.

Under a separate pathway known as “accelerated approval” drugs may be approved based on a so-called surrogate endpoint – a measure, such as tumor shrinkage – that might reasonably be expected to confer a clinical benefit such as improved survival.

Companies that win approval for a product under the accelerated approval process are required subsequently to prove through further clinical trials that the surrogate measure does in fact correlate with improved survival or a reduction in disease symptoms.

“A discussion on this topic is reckless if it doesn’t discuss the next stage after the drug reaches the market,” said Sidney Wolfe, co-founder and senior adviser to Public Citizen’s Health Research Group, a watchdog organization that has frequently criticized the FDA for approving, or failing to withdraw, drugs it considers unsafe.

Woodcock said the FDA is now working to develop a mechanism to speed the development of breakthrough diagnostics that can be used in conjunction with new drugs to help identify which patients will respond to a particular therapy.

Read more: http://www.foxnews.com/health/2013/07/25/us-drugmakers-cheer-speed-lane-for-breakthrough-therapies/?intcmp=obnetwork#ixzz2amhHDnZG

Insulin spray aided memory in Alzheimer’s study

Insulin spray aided memory in Alzheimer’s study

A spritz of insulin in the nose each day helped improve memory skills in people with Alzheimer’s-linked memory problems.

By Julie Steenhuysen, ReutersMon, Sep 12 2011 at 4:05 PM EST
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INSULIN: Studies have suggested a link between type 2 diabetes and Alzheimer’s disease. And several animal studies suggest insulin given through the nose — which delivers it only to the brain — can improve the performance of diabetic mice genetically altered to develop Alzheimer’s disease. (Photo: .:[ Melissa ]:./flickr)
CHICAGO – A daily spritz of insulin in the nose helped improve memory skills in people with Alzheimer’s-linked memory problems, U.S. researchers said on Monday.
Patients in a small study — who include people with mild to moderate Alzheimer’s and a pre-Alzheimer’s condition known as amnestic mild cognitive impairment, or aMCI — showed improvement in overall cognitive function. Those who got the lower dose also showed improvements in recalling details of a story after a brief delay.
“Our results suggest that the administration of intranasal insulin may have a therapeutic benefit for adults with aMCI or Alzheimer’s disease,” Suzanne Craft of the Veterans Affairs Puget Sound Health Care System and the University of Washington School of Medicine, Seattle, and colleagues wrote in the Archives of Neurology.
The study involved 104 patients with mild cognitive decline or mild to moderate Alzheimer’s disease.
Alzheimer’s experts warn that findings need to be confirmed in larger, longer trials, but they said it was a welcome advance at a time when few treatments have shown any sign of improving memory troubles in these patients.
“Anything that shows benefits even in stabilizing cognitive decline is worth noticing right now. Obviously, like any other study, it has to be replicated and independently confirmed. If that happens, then there will be a lot of interest in moving in this direction,” Dr. Sam Gandy of the Mount Sinai Alzheimer’s Disease Research Centerin New York said in a telephone interview.
Study participants were randomly assigned to one of three groups: 36 participants got a moderate dose of insulin sprayed daily into their nose, 36 patients got a higher dose daily and 30 participants got a placebo daily for four months.
All treatments were given through a nasal drug delivery device made by Kurve Technology of Bothell, Washington.
The team looked to see if the treatment had any effect on how well study volunteers could remember a story right after they heard it and a after a short lapse in time.
After four months, the group that got the moderate insulin dose — 20 International Units or IU — showed improvements in delayed story recall compared with the placebo group. There is no improvement in the group that got the high dose of insulin — 40 IU — compared with the placebo group.
Both groups that got insulin also showed improvements in general thinking skills on a common assessment test known as ADAS-cog.
“Taken together, these results provide an impetus for future clinical trials,” Craft and colleagues wrote.
Dr. James Galvin of New York University Lang one Medical Center said although the study was small, it provides “some of the most convincing evidence to date that insulin treatment may alleviate symptoms of Alzheimer’s disease.”
He said studies in large groups of people have suggested a link between type 2 diabetes and Alzheimer’s disease. And several animal studies suggest insulin given through the nose — which delivers it only to the brain — can improve the performance of diabetic mice genetically altered to develop Alzheimer’s disease.
“It’s interesting and promising. What it tells us for sure is this needs to be explored further in larger and longer trials,” said Dr. Laurie Ryan, program director for Alzheimer’s disease clinical trials at the National Institute on Aging, one of theNational Institutes of Health, which funded the study.
But she remained cautious. “In patients, anything can look good at this stage,” she said in a telephone interview.
More than 5.4 million Americans and 35 million people worldwide have Alzheimer’s, the most common form of dementia.
Current drugs temporarily treat symptoms, but there are no drugs that stop progression of Alzheimer’s, which is fatal.
(Editing by Philip Barbara)