Here are some highlights from current pharma and clinical research news, views and data-
Canada Approves Seasonal Flu Nasal Vaccine.
Health Canada for the first time "granted approval for a nasal vaccine FluMist, designed to protect against seasonal flu." The nasal vaccine which is marketed by AstraZeneca Canada, is attractive to many who have a fear of needles. Another benefit of the nasal vaccine is that research finds it is "more effective in children age 2 to 17 than the traditional injectable flu vaccine."
Extended Stroke Treatment Window Appears To Be A Safe Option For Saving Lives.
Extending the time window to treat stroke patients with the clot-dissolving drug tPA from three hours to up to 4.5 hours after the onset of stroke doesn't result in any significant delays in treatment and appears to be a safe option for saving lives," according to a new paper in The Lancet Neurology. The "three-hour post-stroke time limit was set because of fears that use of the clot-dissolving drug beyond that period might cause dangerous bleeding or other complications," but after the "publication of two landmark studies, the American Heart Association, the American Stroke Association and the European Stroke Association revised their guidelines in October 2008 to recommend that tPA be used up to 4.5 hours after the onset of an ischemic stroke." Still, "experts have been worried."
So, researchers at the Karolinska Institute "analyzed data from 23,942 patients with ischemic stroke who were included in SITS-ISTR [the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry] between December 2002 and February 2010," and reported that "although the rate of symptomatic hemorrhage and death was higher among those treated beyond three hours -- and the rate of functional independence was lower -- the benefits of treatment in that window outweighed the risks," the researchers explained. In fact, "safety and functional outcomes are less favorable after three hours, but the wider time window now offers an opportunity for treatment of those patients who cannot be treated earlier."
FDA Adds Boxed Warning To Plavix.
FDA "is adding its strongest warning to the label for Plavix [clopidogrel bisulfate], cautioning that some patients do not respond to the blockbuster blood thinner." The "warning indicates that the drug is dangerous only in the sense that it doesn't work in" certain "patients and thus may leave them unprotected against heart attacks and strokes." Specifically, some patients have a difference in a liver enzyme known as CYP2C19, which helps to convert Plavix to a form that the body can use, Notably, FDA officials said CYP2C19 tests typically cost less than $500. Robert Temple, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, said, "What there hasn't been is a clear test of whether you can take people who are poor metabolizers, double their dose and do just as well.
Reovirus May Hold Promise As Nontoxic Prostate Cancer Treatment.
The respiratory, enteric, orphan virus, or 'reovirus' is widespread," but those who are exposed to it tend to "suffer, at most, mild flu-like respiratory symptoms or diarrhea." More interestingly, the "reovirus has 'oncolytic' potential," as there "is already some evidence of its effect against lymphoid, ovarian, breast, pancreatic, and high grade glioma brain cancers."
With that in mind, researchers in Canada "recruited six men with early-stage prostate cancer that had not yet started to spread. Each was given a single injection of the virus into their tumor, guided by ultrasound." After three weeks, "patients had their prostate glands removed as part of their normal treatment." Investigators were then able to see that the virus "triggered the cancer cells' self-destruct program. All around the injection site, the reovirus -- a product from Oncolytics Biotech Inc. called Reolysin -- made cancer cells go away" without harming normal cells. The only flaw was that "the virus did not spread throughout the prostate," meaning "cancer cells not in the immediate area of the injection were spared.
Research Team Finds Q Fever Demands 18 Months Or More Of Treatment.
Researchers based in France have outlined treatment for Q fever, and "the findings have relevance because of the current -- and unusual -- outbreak of Q fever in the Netherlands, where 3,483 cases have been diagnosed since 2007 and six people have died." Dr. Didier Raoult, of the University of the Mediterranean and colleagues, published results of their study of 104 patients in the journal Lancet Infectious Diseases. The team said that "at least" 18 months of treatment are necessary to "cure an infection of the heart lining or valves resulting from Q fever, and an additional six months will most likely be required if the patient has a prosthetic valve."
Read more at-
Canada Approves Seasonal Flu Nasal Vaccine.
Health Canada for the first time "granted approval for a nasal vaccine FluMist, designed to protect against seasonal flu." The nasal vaccine which is marketed by AstraZeneca Canada, is attractive to many who have a fear of needles. Another benefit of the nasal vaccine is that research finds it is "more effective in children age 2 to 17 than the traditional injectable flu vaccine."
Extended Stroke Treatment Window Appears To Be A Safe Option For Saving Lives.
Extending the time window to treat stroke patients with the clot-dissolving drug tPA from three hours to up to 4.5 hours after the onset of stroke doesn't result in any significant delays in treatment and appears to be a safe option for saving lives," according to a new paper in The Lancet Neurology. The "three-hour post-stroke time limit was set because of fears that use of the clot-dissolving drug beyond that period might cause dangerous bleeding or other complications," but after the "publication of two landmark studies, the American Heart Association, the American Stroke Association and the European Stroke Association revised their guidelines in October 2008 to recommend that tPA be used up to 4.5 hours after the onset of an ischemic stroke." Still, "experts have been worried."
So, researchers at the Karolinska Institute "analyzed data from 23,942 patients with ischemic stroke who were included in SITS-ISTR [the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry] between December 2002 and February 2010," and reported that "although the rate of symptomatic hemorrhage and death was higher among those treated beyond three hours -- and the rate of functional independence was lower -- the benefits of treatment in that window outweighed the risks," the researchers explained. In fact, "safety and functional outcomes are less favorable after three hours, but the wider time window now offers an opportunity for treatment of those patients who cannot be treated earlier."
FDA Adds Boxed Warning To Plavix.
FDA "is adding its strongest warning to the label for Plavix [clopidogrel bisulfate], cautioning that some patients do not respond to the blockbuster blood thinner." The "warning indicates that the drug is dangerous only in the sense that it doesn't work in" certain "patients and thus may leave them unprotected against heart attacks and strokes." Specifically, some patients have a difference in a liver enzyme known as CYP2C19, which helps to convert Plavix to a form that the body can use, Notably, FDA officials said CYP2C19 tests typically cost less than $500. Robert Temple, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, said, "What there hasn't been is a clear test of whether you can take people who are poor metabolizers, double their dose and do just as well.
Reovirus May Hold Promise As Nontoxic Prostate Cancer Treatment.
The respiratory, enteric, orphan virus, or 'reovirus' is widespread," but those who are exposed to it tend to "suffer, at most, mild flu-like respiratory symptoms or diarrhea." More interestingly, the "reovirus has 'oncolytic' potential," as there "is already some evidence of its effect against lymphoid, ovarian, breast, pancreatic, and high grade glioma brain cancers."
With that in mind, researchers in Canada "recruited six men with early-stage prostate cancer that had not yet started to spread. Each was given a single injection of the virus into their tumor, guided by ultrasound." After three weeks, "patients had their prostate glands removed as part of their normal treatment." Investigators were then able to see that the virus "triggered the cancer cells' self-destruct program. All around the injection site, the reovirus -- a product from Oncolytics Biotech Inc. called Reolysin -- made cancer cells go away" without harming normal cells. The only flaw was that "the virus did not spread throughout the prostate," meaning "cancer cells not in the immediate area of the injection were spared.
Research Team Finds Q Fever Demands 18 Months Or More Of Treatment.
Researchers based in France have outlined treatment for Q fever, and "the findings have relevance because of the current -- and unusual -- outbreak of Q fever in the Netherlands, where 3,483 cases have been diagnosed since 2007 and six people have died." Dr. Didier Raoult, of the University of the Mediterranean and colleagues, published results of their study of 104 patients in the journal Lancet Infectious Diseases. The team said that "at least" 18 months of treatment are necessary to "cure an infection of the heart lining or valves resulting from Q fever, and an additional six months will most likely be required if the patient has a prosthetic valve."
Read more at-
