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DRUG DEVELOPMENT

RX For Stroke Victims: Irish Coffee - Iced

A San Diego company believes a mixture of caffeine and alcohol along with its cooling technology might minimize damage to the brain when the flow of blood becomes blocked.

DANIEL S. LEVINE

The Burrill Report

“We're not trying to build a novel and high-priced therapeutic. What we are trying to do is build a business around our cooling therapies.”
The allure of mixing caffeine and alcohol are apparent to any connoisseur of Irish coffee, but a San Diego company thinks the combination may offer protection to the brain following a stroke. What’s more, the firm’s cooling technology, also being studied for that same purpose, could be further enhanced by the blend.
 
InnerCool Therapies said it has licensed Caffeinol—a potential therapeutic for use in acute ischemic stroke patients—from the University of Texas Health Science Center at Houston. Caffeinol is a cocktail of caffeine and alcohol delivered intravenously.
 
“It’s basically the equivalent of a vente cappuccino from Starbucks and a straight whisky,” said Randall Moreadith, chief medical officer for InnerCool Therapies and Cardium Therapeutics, which is InnerCool’s San Diego-based parent company. “The beauty of this is both caffeine and alcohol have been used therapeutically for decades, so there’s a well established safety database for either one individually or now in combination.”
 
Under the exclusive license, InnerCool will evaluate the safety and efficacy of treating stroke patients with Caffeinol in combination with its technology to lower the temperature of stroke patients. A study has been proposed to the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.
 
InnerCool produces an endovascular-cooling device, which is marketed as the Celsius Control System. The system involves the insertion of a catheter through the groin into the vena cava, the major vein that blood passes through right before it is returned to the heart. The catheter is a closed-loop system that carries a saline solution that does not mix with the blood. As blood passes by the catheter it cools it to maintain a desired temperature.
 
Powerful Results
Cooling is a simple technology that has demonstrated powerful therapeutic results. It has started to get some attention lately both in medical journals as well as the lay press. InnerCool first won U.S. Food and Drug Administration approval for the Celsius Cooling System in 2003 for use to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and recovery/intensive care. Subsequent indications for the system have also been obtained in fever control and cardiac surgery.
 
The use of cooling in heart attack and stroke patients, though, is getting attention as a possible way to minimize the damage caused by them. InnerCool’s decision to license caffeinol represents a broader effort on the part of the company to expand the therapeutic uses of cooling and push the technology into new areas, while gaining increased appreciation of its potentially broad applications. 
 
“We’re not trying to build a novel and high-priced therapeutic,” said Christopher Reinhard, chairman and CEO of Cardium Therapeutics and InnerCool Therapies said of Caffeinol. “What we are trying to do is build a business around our cooling therapies using our high-powered endovascular cooling systems to further grow and work on what we call ‘the power of cool.’”
 
Good Combo
James Grotta, director of the Stroke Program and Professor of Neurology at the University of Texas Medical School at Houston had been exploring whether either caffeine or alcohol could offer act as neuroprotectives and provide any benefit to stroke patients. His lab decided to see not just whether either showed benefit, but whether a combination of the two did as well.
 
Both substances are known to have effects on key neurotransmitters, but Grotta found in rat models of stroke, caffeine had no effect and alcohol had a detrimental one. That’s why he was startled to find in combination, it demonstrated neuroprotective abilities. In the animal models of ischemic stroke, rats infused soon after the onset of the stroke with caffeine and alcohol had a reduction in the size of damaged tissue by about 65 percent. What’s more, when it was used in combination with hypothermia—cooling down to about 33 degrees Celsius (91.4 degrees Fahrenheit)—the size of infarction in animals was reduced by about 90 percent.
 
Stroke is now the third most prevalent cause of deaths among adults in the United States and the leading cause of serious long-term disability. The clot-busting tissue plasminogen activator or tPA is the only approved drug for use when someone suffers a stroke, and that must be administered within three hours of the event. The effort to find neuroprotective agents that could minimize the damage caused by a stroke has been wrought with clinical failures.
 
An NIH-sponsored clinical trial is currently underway to evaluate the safety of InnerCool’s technology in patients with acute ischemic stroke along with tPA. The company hopes to win backing from the NIH to test Caffeinol and its hypothermia alone with tPA and in combination with tPA.
 
Multiple Pathways
Why cooling or Caffeinol appears to have a neuroprotective effect is not known. The belief is that rather than acting on a single pathway, cooling and Caffeinol acts on multiple pathways involved in a cascade of events that kill brain cells following a stroke. 
 
An NIH-sponsored clinical trial is currently underway to evaluate the safety of InnerCool’s technology in patients with acute ischemic stroke along with tPA. The company hopes to win backing from the NIH to test Caffeinol and its hypothermia alone with tPA and in combination with tPA.
 
The University of Texas’ Grotta said the combination of Caffeinol and hypothermia may be among one of the last efforts at neuroprotection in stroke because of the many failures that have preceded it.
 
“Most people are getting very discouraged about neuroprotection as a strategy and particularly of using animals to model stroke because of the failures to date,” he said, noting the high profile failure of a late-stage AstraZeneca trial last year and one ongoing test of albumen as a neuroprotective agent. “If the albumen trial is not positive, as far as I’m concerned, this trial is sort of a last chance at neuroprotection.”


October 22, 2007
http://www.burrillreport.com/article-rx_for_stroke_victims_irish_coffee_iced.html

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