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 | News: Campath Trials Temporarily Halted; Shows Promise |
 MS'ers have gotten used to a "two steps forward and one step back" rate of progress over the past year, accentuated by the Tysabri-PML issue. The trend continues with Genzyme's Campath therapy, which reported good results, but serious side effects that will require the trials to be put on hold indefinitely while more stringent safety standards are put into place.
Campath is a cancer treatment that is currently approved to treat the rare cancer called B-cell chronic lymphocytic leukemia. Trials in MS have shown promise-- and in this latest round of results, Campath patients were only 25% as likely to have a relapse of symptoms as patients taking the interferon Rebif. Campath also showed some indicators of slowing long-term disease progression, but not enough to be seen as statistically significant.
Unfortunately with the two steps forward, comes one back: There were 3 serious adverse events reported, with one of those leading to a patient death. 3 of 219 MS patients dosed with Campath were diagnosed with a blood condition called idiopathic thrombocytopenic purpura, a highly dangerous drop in blood platelets that help clot wounds.
This possible side-effect is already on the label for the cancer treatment indication. The patient who died had shown symptoms of the condition for a month before seeking medical care. The other two patients were diagnosed more quickly and are responding to treatment.
Genzyme said it intends to continue testing the drug, but only after working with regulators to improve the safety of the trials. Obvious changes include monitoring patients more closely, as well as instructing them to look for symptoms of the blood condition before it becomes irreversible.
And so the dance continues...
Click "read more" for more information...
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Posted by Administrator on Tuesday, September 20 @ 04:44:27 EDT (3223 reads)
(Read More... | 2101 bytes more | News | Score: 2.75)
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| Lessons from Campath: Early Protection of CNS Critical |
Campath-1H is a experimental treatment for MS currently in clinical
trials. While this new report touches upon the promising efficacy of
the treatment, its main focus is on the difference between the
effectiveness of therapeutic intervention at the relapsing-remitting
stage of Multiple Sclerosis versus the secondary progressive stage. The
ultimate conclusion is that early and potent treatment can
significantly improve the patient's health, whereas attempting to do
the same when the disease has already progressed lacks impact. In a
very important point, this is even true when the MRI scans show no
further disease progression-- reiterating what we have learned about
secondary progressive MS not being an inflammatory condition, but rather one of neuronal/axonal loss and/or degradation.
Now this study does not mean that people who are secondary progressive
are beyond therapeutic hope-- what it implies is that secondary
progressive patients will not benefit from this specific type of
treatment targeting the reduction of inflammatory cells (e.g., likewise
with Tysabri), presumably because the disease is no longer an
inflammatory condition by that point. This is a positive finding, as it
helps narrow the scope of treatment rather than blindly trying various
poweful therapies in the hopes one will work. As bystanders to the
research, it becomes quite clear that treating MS effectively will
require tailored therapies-- if not to the individual then to the
individual's disease stage. While we already see this in the current
therapies, reinforcement breeds familiarity.
"From
1991-2002, we treated 58 patients with multiple sclerosis (MS) using the
humanised monoclonal antibody, Campath- 1H, which causes prolonged T lymphocyte
depletion. Clinical and surrogate markers of inflammation were suppressed. In
both the relapsing- remitting (RR) and secondary progressive (SP) stages of the
illness, Campath-1H reduced the annual relapse rate (from 2.2 to 0.19 and from
0.7 to 0.001 respectively; both p < 0.001). Remarkably, MRI scans of patients
with SP disease, treated with Campath-1H 7 years previously, showed no new
lesion formation. However, despite these effects on inflammation, disability was
differently affected depending on the phase of the disease."
Click "read more" for the full abstract...
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Posted by Administrator on Friday, July 29 @ 14:34:44 EDT (2510 reads)
(Read More... | 7251 bytes more | Score: 4.5)
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| Clinical Trials: Campath for Multiple Sclerosis Completes Phase III Enrollment |
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Some news on Campath, a chemotherapy treatment for multiple sclerosis that has shown good success in earlier trials and has now finished enrollment for Phase II. Note that after Antegren, Campath is the next next multiple sclerosis treatment to be up for release.
"ILEX(tm) Oncology Inc. announced today that it has met its enrollment target of 240 patients in its global, multi-center Phase II trial of CAMPATH(R) (alemtuzumab) in previously untreated relapsing/remitting multiple sclerosis (MS). The Company announced in January that it was expanding the size of the trial from 150 patients to 240 patients based on growing interest among investigators and patients, as well as repeated recommendations of the independent data safety monitoring board to continue the study...
In a CAMPATH pilot study reported at the 2003 American Academy of Neurology annual meeting by Professor Alastair Compston, chairman of neurology, University of Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom, 17 previously untreated patients with early, active relapsing-remitting MS without progression or severe disability experienced a near-complete reduction in annualized relapse rate, and in no patient did disability increase."
Click "read more" for the full release...
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Posted by Administrator on Friday, April 23 @ 01:43:17 EDT (3751 reads)
(Read More... | 8730 bytes more | Clinical Trials | Score: 0)
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