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Great news on Campath
Posted: Mon Jun 14, 2010 5:02 pm
Genzyme's Alemtuzumab for Treatment of Multiple Sclerosis Granted Fast Track Status by FDA
CAMBRIDGE, Mass., Jun 14, 2010 (BUSINESS WIRE) -- Genzyme Corporation /quotes/comstock/15*!genz/quotes/nls/genz (GENZ 49.50, +0.45, +0.92%) announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.
The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Under Fast Track designation, alemtuzumab for MS is eligible for Priority Review and the FDA may consider for review portions of the marketing application before the submission of a New Drug Application (NDA) is completed.
"We are extremely pleased that our alemtuzumab development program has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program's review process," said Henri Termeer, Genzyme's chairman and chief executive officer. "Alemtuzumab is a potentially transformative therapy for the treatment of multiple sclerosis, and an important part of our future."
Alemtuzumab for the treatment of MS is currently being evaluated in two pivotal multi-center, multi-national trials, known as CARE-MS(SM) (Comparison of Alemtuzumab and Rebif(R) Efficacy in Multiple Sclerosis). The company's CARE-MS I Phase 3 trial is a randomized study comparing alemtuzumab to the approved therapy Rebif (high-dose interferon beta-1a) in early, relapsing-remitting multiple sclerosis (RRMS) patients who have received no prior therapy. The second Phase 3 trial, CARE-MS II, is comparing alemtuzumab to Rebif in RRMS patients who had active disease while on other MS therapies.
Both trials are fully enrolled and data are expected to be available in 2011.
About Campath(R) (alemtuzumab)
Campath(R) is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for the treatment of B-CLL in patients who have been treated with alkylating agents and for whom fludarabine combination therapy is not appropriate. The product was launched in its oncology indication in 2001 in the US, where it is marketed as Campath(R), and in Europe, where it is named MabCampath(R).
Campath for B-CLL has a boxed warning that includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions in patients with B-CLL were infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.
Posted: Sat Jun 26, 2010 7:31 am
The stats have come out very good for Campath. Not much activity here on the campath forum! I hear that 1 treatment with campath costs $18,000! How long before it will be available to everyone?
I couldn't stand to see 0 replies on your post. Thanks for keeping the forum up to date! ccsvi alone won't be enough, I feel now that I've had both (campath and liberation) next I need (someone else's undifferentiated) stem cells.
And of course a diet for reduced inflammation and proper vitamin supplementation, sleep well and the right kind of exercise for "dead" limbs...
Posted: Sat Jun 26, 2010 6:09 pm
it's been 2 years/2 infusions of campath. kept the disease from a rapid decline to a slower steady decline, therefore good per my docs. all written up on this forum
i'm part of those "good" statistics that mendesnelson posted. see how it's a stock quote article, and didn't give the research just published
9 days status post stent & angio and too early to rant and rave, though i'm impressed so far. it was a local doc willing to give it a shot on a few of us. i'm a big proponent of calling every IR doc/ Vein specialists in your area & see if you can find one interested in trying it out. Can you do this in London? Call around and look for a doc to infuse campath "off label" for a small fee of $18,000 ?
or see a vein specialist willing to have a look @ "venous insufficiency" and not talk much about the other disease (MS)?
all the best to ya !
My Campath Infusion
Posted: Sun Jun 27, 2010 10:47 pm
Thank you for keeping the post going, everyone. I was part of the original cohort of Campath patients givin the high-dose Campath. I was diagnosed with MS in June 2003 and was enrolled in the Campath trial the next month at Stony Brook Hospital NY. I received two full infusions of Campath spaced one year apart....so my last infusion was summer of 2004. Havent had any medicinal treatments for my MS since then. My yearly MRIs after having had Campath have always been negative for progression/lesion count and enhancing lesions. However, I was one of the few that developed GRAVES Disease about 1 year after my last infusion. Ive been managing it with oral Tapazole but am considering having a thyroidectomy soon because it has bothered my eyes somewhat (just mildly but no bulging) and radioactive iodine is contraindicated for Graves with eye symptoms as it might worsen it (though giving corticosteroids prior to radioactive ablation seems to prevent worsening of the eye symptoms...but I rather not risk it).
Posted: Mon Jun 28, 2010 4:41 am
I, too, got the high dose (25mg x2 doses)
So far no serious tx related problems, but I know I am at a higher risk for thyroid since they screened for TPO antibodies, and i was positive, so I signed I knew I was at a higher rate for this. Also, I fear ITP! Haven't heard from fellow TIMS-Campath participant, Grumpster, who did get ITP post campath