http://oc1dean.blogspot.com/2011/08/sygnis-pharma-ag-has-completed-patient.html
The newest failure here:
http://www.medpagetoday.com/MeetingCoverage/ASAMeeting/31032?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g424561d0r&userid=424561&email=oc1dean@yahoo.com&mu_id=
An agent used for treating chemotherapy-induced neutropenia in patients with nonmyeloid malignancies had no effect on outcomes for patients with acute ischemic stroke, a randomized trial showed.
At 90 days, functional outcomes were similar whether patients received recombinant human granulocyte colony-stimulating factor, known as filgrastim (Neupogen), or placebo, according to E. Bernd Ringelstein, MD, of the University of Münster in Germany.
There were no effects on any other outcomes either, he reported at the American Stroke Association's International Stroke Conference here.
He said there were no clear explanations for why the drug failed to live up to the expectations engendered by a successful preclinical program.
"Our results confirm a principle problem in the translation of preclinical work into the clinical stroke trials," he said, "and it seems we are again thrown back to [a] statement from the 80s, saying that 'The outlook for stroke therapy is excellent ... if you are a rat.'"
Filgrastim, called AX200 for the purposes of the stroke studies, was expected to work in acute ischemic stroke because granulocyte colony-stimulating factor and its receptor are expressed by neurons as a protective response to injury. In the brain, the agent has anti-apoptotic properties and stimulates neurogenesis, arteriogenesis, and neurite growth.
In the phase IIa AXIS study, the treatment was safe and well tolerated in patients with acute ischemic stroke, leading to the creation of the phase III AXIS-2 study, which was conducted in seven European countries.
The researchers randomized 328 patients with an acute ischemic stroke in the middle cerebral artery territory. All were younger than 85 (mean age 69) and all were treated less than nine hours after stroke onset.
About two-thirds of the patients had received IV tissue plasminogen activator (tPA) before randomization.
AX200 was given intravenously at a dose of 135 µg/kg over 72 hours.
The drug did what it was supposed to do in the blood, increasing in concentration in the plasma, stimulating production of white blood cells and monocytes, and slightly reducing platelet count.
But the drug failed to improve the modified Rankin Scale score at 90 days. The average score was 3.31 in the treatment arm and 3.12 in the placebo arm (P=0.3034).
There was also no difference on the NIH stroke scale score (8.88 versus 8.45, P=0.6121) or on 90-day mortality (22% versus 18%, P=0.4042).
The results were consistent regardless of whether the patients received thrombolytic therapy before entering the study.
Serious adverse events occurred at similar rates in the two groups including:
- Nervous system disorders: 27.1% witih AX200 and 15.3% with placebo
- Infections: 8.1% and 8.6%
- Respiratory, thoracic, and mediastinal disorders: 4.3% and 6.7%
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