Thanks, Mary....I'm sending this to my DD, Julie. This may be a good trial for her ro get in on.

On second thought, here are the FDA warnings that go with..

Campath®
(alemtuzumab) Injection for Intravenous use
Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS].
Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jirovecipneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Campath (alemtuzumab) is a recombinant DNA-derived humanized monoclonal antibody (Campath-IH) directed against the 21-28 kD cell surface glycoprotein, CD52. Campath-1H is an IgGl kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). The Campath-1H antibody has an approximate molecular weight of 150 kD. Campath is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product.
Campath is a sterile, clear, colorless, isotonic solution (pH 6.8-7.4) for injection. Each single use vial of Campath contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added.

"About Alemtuzumab

Alemtuzumab 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 who have failed fludarabine therapy. The product was launched in its oncology indication in 2001 in the US, where it is marketed by Bayer HealthCare Pharmaceuticals Inc. as Campath(R), and in Europe, where it is named MabCampath(R).

Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body's immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL.

Genzyme and Bayer Schering Pharma AG, Germany are co-developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany holds exclusive worldwide marketing and distribution rights to alemtuzumab.

Campath has a boxed warning which 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). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. 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."

"Three percent of alemtuzumab-treated patients developed the potentially serious autoimmune adverse event immune thrombocytopenic purpura (ITP), a disorder characterized by a low platelet count and corresponding increased risk of uncontrolled bleeding."

"... immune thrombocytopenic purpura (ITP). ITP is a disorder characterized by a low platelet count and corresponding increased risk of uncontrolled bleeding. ... In the previously reported alemtuzumab-related fatal case, symptoms of ITP were experienced but were not recognized in time, thus delaying medical attention. Of the remaining alemtuzumab cases, four patients were diagnosed promptly, responded well to medical treatment, and have been stable without a need for ongoing treatment. The other alemtuzumab-treated case experienced spontaneous remission of ITP.

Common non-serious adverse events in the trial included infusion-associated reactions in the alemtuzumab patients and flu-like symptoms in patients using Rebif. Alemtuzumab-treated patients were more likely than Rebif patients to experience infections, particularly of the upper respiratory tract; infections were predominantly mild to moderate in severity and there were no life-threatening or fatal infections. Though alemtuzumab transiently lowers white blood cell counts, the trial did not show an increased risk of opportunistic infections. Serious infections were infrequent in the alemtuzumab-treated patients. Approximately 23 percent of alemtuzumab-treated patients developed autoimmune thyroid-related adverse events, including Graves’ disease, and were managed using conventional therapies.

Alemtuzumab is an investigational drug for the treatment of MS and must not be used in MS patients outside of a formal, regulated clinical trial setting in which appropriate patient monitoring measures are in place."

http://www.msrc.co.uk/index.cfm?fuse...ow&pageid=1307

Cherie

Campath has been in the testing-works for quite some time.

Here's an article in Business Week

http://www.businessweek.com/technolo...ge_top+stories

The thisisms.com boards have a forum on campath....I've read it - and was just not impressed - people who have had the treatment have posted there. Looks like a nightmare to me - but if it helps, then I guess it's worth it? I got nervous when I read that some patients have worsened disability. Uh oh, no way for me!

Of course, I was a lab rat for HiCy/Revimmune - and I had no ill effects and only improvement

~Keri

Yep, I'm afraid, it sounds like another damn poison..

When my son first heard this story reported on the news they touted it as a miracle "cure" for MS. saying that it "reversed myelin damage" and the only side effect they mentioned was body tingling! Talk about misleading! Were they paid by the drug company to just pass over all the other more serious side effects?

I'm afraid anything that is aimed at stopping our bodies from attacking themselves will have serious side effects. If I've read correctly and the major risks are cytopenias, infections and infusion reactions I don't think that is too bad.

The blood dyscrasias can be monitored for and I think should reverse if the med is stopped. The infection risk sadly is something that I think we will have to gamble on and just be extra carefeul with any of these 'high-power' meds, sigh. Infusion reactions again, I believe, should be fairly mild in most people and possibly treated with pre-medication or in some by stopping the medication.

All in all better than the risk of organ damage, imo. However on the flip side I don't think this study of 300+ people in the 'early stages' is all that impressive. How many of us did great in the first few years? Quite a few I'd guess. Any new advancements is good news because while it might not help all of us or even most of us if it adds another option for one of us fighting this miserable disease I give it a thumbs up.

I'm in the middle of reading some of the scientific stuff on this drug. There's some scary stuff going on with it. It's probably only going to be used for the worst cases.

There's been 8 deaths associated with it in the trials, and YES, there is PML associated with it.

I'd like to hear from the folks who are in the trials or on it outside of the trials. Anyone here yet?

Like Tysabri, it has been noted that there is an increase in brain volume. It's not noted yet whether the Campath volume increase is due to swelling or actual repair.

Changed my mind...to dangerous for my DD..