One more coicidence!
Read this! Looks like AMGN is more concern about GDNF phase I,
than for BDNF failure. They published news on Jan 14., two days after BDNF announcement. But, Dr. Bradley said that BDNF did'nt work, probably, because didn't reach the brain.
Doctors try new treatment for Gehrig's
disease
Source: Reuters
MIAMI, The Reuters World Service via Individual Inc. : Injecting a new
high-tech drug directly into the brain could be the solution to a problem that
has dogged medicine for decades, the degenerative nerve condition
amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease,
doctors said on Tuesday.
``We're very excited about what is happening here, but it is very early stages.
This is still very experimental,'' said Dr. Walter Bradley, chairman of the
University of Miami's Department of Neurology, who is lead investigator of
the first clinical trial of the delivery system and the drug.
Doctors at six medical centres have just begun a Phase I clinical trial in which
they will implant a device into 24 patients that will allow them to inject GDNF,
or Glial Cell-Derived Neurotrophic factor, a new drug developed by Amgen,
directly into their brains.
The drug had been shown to promote the growth of nerve cells in animals.
Now doctors are testing the drug on humans for the first time, but they also
hope using the ``port'' developed by Medtronic Inc to inject it directly to
where cells are growing will prove more effective than earlier trials in which
other drugs were injected under the skin.
In those trials, Bradley said, medicines might have proved ineffective because
they were stopped by the blood-brain barrier, which protects the brain from
many substances that enter the bloodstream.
Last week, Amgen and Regeneron Pharmaceuticals Inc announced that
subcutaneous delivery of another highly touted drug, Brain-Derived
Neurotrophic Factor (BDNF), had not proven effective.
``It didn't work, and probably the reason that it didn't work is that the drugs
didn't reach the brain,'' Bradley said.
ALS patients suffer a slow death, during which they become progressively
weaker as their nerve cells die. The disease is best known as the killer of the
baseball star Lou Gehrig.
Ken Sibley, the first patient in the trial announced on Tuesday, was diagnosed
with ALS last March and told he had no more than three years to live.
Bradley said there is just one drug available to ALS patients which slows the
progress of the disease. He said the hope for the current trial was that GDNF
would make the cells die more slowly or even stop them from dying.
``GDNF looks to be in the laboratory, at any rate, probably the most
encouraging drug, in terms of the effect upon motor nerve cells,'' Bradley said.
Sibley, 39, from Birmingham, Ala., had lost his ability to speak by Tuesday. A
year ago, the real estate executive was on a ski vacation with his family,
shortly before a neurosurgeon friend noticed his slurred speech and suggested
medical care.
Sibley was diagnosed with ALS last March. Shortly afterward, he contacted
Bradley, a leading ALS researcher, and was placed his waiting list for clinical
trials of new drugs.
Although there was a chance he would not receive the drug during the first
nine months of the trial -- two-thirds will receive GDNF and one-third a
placebo -- Sibley said he jumped at the chance for treatment, for which a slim
plastic tube was installed in his brain last month.
``This is his hope. He feels like he owes it to his family to try, to live... and to
fight,'' said Rebecca Sibley for her husband, who communicated with her by
typing into a computer.
The first part of the trial will last for nine months. Bradley said it could take up
to another to two years to determine whether the drug and probe combination
is effective.
He said that, if successful, the trial could lead to treatment for diseases such as
Alzheimer's and Parkinson's. ``This combination could be the mechanism of
the future,'' Bradley said. |
