Therapeutics

On November 20, 2006, in Therapeutics

Brain Implant for Stroke Victims

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Northstar Neuroscience’s clinical trial of a brain implant to help stroke victims regain control of hands and arms is “one quarter [i.e., 3 months] ahead of schedule,” reports Andrea James in the Seattle Post-Intelligencer, and the company has won approval to enroll patients for another trial of the device, this time to treat depression. The “Northstar Stroke Recovery System” includes a stamp-sized electrode that stimulates the cortex of the brain to compensate for post-stroke loss of speech and motor skills and ringing in the ears.

“Though the company is new to Wall Street,” writes James, “its five analysts have rated it positively and the company is generally respected.” One of them (not involved in the company’s IPO, so relatively disinterested) told her: “One of the things we look at is, ‘Will a technology be pushed or pulled through the FDA?’ This device will be pulled through the FDA like none before it. . . . Every so often, you come up with a company that will author a genuine life-changing technology. This is it.” The product is expected to be on the market in the first quarter of 2009, assuming FDA approval following the anticipated delivery of positive trial data in the final quarter of 2007.

Artificial Pancreas to be Tested

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Children in the UK with type 1 diabetes are being recruited to test an artificial pancreas consisting of a glucose sensor that continuously monitors blood sugar level, a computer that computes the insulin dose needed to restore the level to normal, and an insulin pump to deliver the dose. The purpose of the trial is to perfect the computer algorithm. It could be four to seven years before it is available commercially. Many diabetics already use an insulin pump but they still have to test their blood many times each day to measure their blood glucose and continuous, non-invasive monitoring would be both safer and eliminate the pain and inconvenience of repeated findger pricks. The continuous glucose sensors are the size of a credit card and worn on the skin. They read glucose levels on a minute-by-minute basis using a small sensor implanted under the skin.

Trials have already shown that patients using continuous glucose sensors spend 26 percent more time in normal glucose range, compared to patients using the finger prick method, and have statistically significant improvements in HbA1c. Cambridge University is one of nine international research centers testing the artificial pancreas, according to the BBC News.

Getting the Jump on Bacteria

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After discovering a set of grammar-like rules of order and placement that govern naturally occurring antimicrobial peptides (small proteins that attack the membrane walls of microbes causing them to rupture), MIT scientists have created 40 new artificial bacteria-fighters. “Nearly half of them vanquished a variety of bacteria and two of them beat anthrax,” reports Seth Borenstein of the the Associated Press This potentially creates not just a new type of weapon against hard-to-fight germs, but also a way to respond quickly to bacteria that develop resistance to drugs and conceivably to predict and be ready for resistant strains.

Promising Alzheimer’s Drugs

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In a comprehensive survey of the state of Alzheimer’s therapies, the Wall Street Journal’s Elena Cherney notes that a few drugs are showing some success in clinical trials at slowing cognitive decline. Some of these drugs are already approved for other diseases. A few, including a prostate-cancer drug, a diabetes drug and a medicine derived from an old class of anti-inflammatory drugs, are in late-stage trials and could be on the market in a few years. Other promising compounds include cholesterol-lowering statins and antibodies that bolster the immune response against Alzheimer’s. The significance of these various drugs is that they seek to modify the brain processes that cause Alzheimer’s, whereas the currently approved medicines — Aricept, Exelon, Razadyne and Namenda — only provide limited and short-term relief from cognitive decline.

Among the promising new drugs:

  • Myriad Technologies’ Flurizan, derived from an anti-inflammatory, targets an enzyme believed to play a role in the build-up of amyloid. US clinical trials should be concluded by the spring of 2008. 

     

  • Voyager Pharmaceuticals’ leuprolide, a prostate-cancer drug being tested in Alzheimer’s patients, targets luteinizing hormone, a pituitary hormone believed to promote the production of beta-amyloid. In a study of 50 women with mild to moderate Alzheimer’s disease, those who took the drug for 48 weeks saw a dramatic slowing of their deterioration, compared with women who didn’t get the drug. (A study among men was not as compelling, perhaps because luteinizing hormone increases dramatically in women after menopause. A US phase III trial concludes in Fall 2007. 

     

  • GlaxoSmithKline’s diabetes drug Avandia showed improvement in patients with a certain gene. Phase III trials involving 2,800 patients in the US and 32 other countries are getting under way. 

     

  • A recent study has test whether Merck’s Zocor statin can stall Alzheimer’s in patients with normal cholesterol levels. It appears to lower the amount of amyloid in the brain. Pfizer is also recruiting patients for a study of its Lipitor statin in Alzheimer’s patients. 

     

  • Neurochem’s Alzhemed has kept patients with mild Alzheimer’s stable for 20 months. Some patients who participated in an extended study have been stable for three years. 

     

  • Eli Lilly is in the early stages of trials of an antibody that binds to beta-amyloid and prevents it from building up. The company is further along in trials of a drug that moderates the activity of an enzyme that appears to promote the production of amyloid. 

     

  • Wyeth is working with Elan Pharmaceuticals to develop an injectable protein that would prevent the build-up of beta amyloid.
 

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