[FinLady]

Found this as I was surfing the news. It's about a trial for Alemtuzumab that looks hopeful. Find it kinda ironic for myself. My father is on the "wait and see" stage for the type of leukaemia this drug usually helps.

http://news.yahoo.com/s/afp/20081023...ql9svNyCOs0NUE

[wkikta]

Just reading about it a little bit ago. Is a Phase II study, but looks very promising. Still a needle, but very good numbers.

[mbabic]

I have not, but this is interesting. Thanks. Mary

[dmplaura]

Yup. What I read seems to be a concern of the potential side effects, but that's nothing new with drug options right?

I had a friend link me an article about this right after reading this thread.

[Catch]

I just heard this today as well. Here's a complete article. They're getting geared up for a Phase III study, and say it may be on the market in 4 years. I'd like to know more about what they mean by "early stage" MS. How many years defines early stage? 5, 10?

"

LONDON (Reuters) - A drug developed to fight leukemia appears to stop multiple sclerosis in its early stages and restore lost function to patients, British researchers said on Wednesday.

The three-year study of Bayer AG and Genzyme Corp's alemtuzumab for the first time show long-term improvement in disability, Alasdair Cole, a neurologist at the University of Cambridge, said in a telephone interview.

The drug, made under the brand name Campath, appears to regenerate brain cells and reverse the effects of relapsing-remitting multiple sclerosis, the researchers found.

"This is the first drug that has shown that people's disability at the end of a period of time has actually improved," Cole, who helped lead the study, said. "That is really encouraging for people with the disease."

Multiple sclerosis is a disease in which the immune system mistakenly attacks and damages the myelin sheath that protects nerve cells. It affects 2.5 million people globally and can cause symptoms ranging from vague tingling to blindness and paralysis.

Standard treatments using a protein known as recombinant interferon beta include Biogen Idec Inc's Avonex, the newer treatment Tysabri, developed by Biogen Idec and Elan, and Merck KGaA's Rebif.

The study compared alemtuzumab to Rebif in 300 men and women with early stage MS, marked by flare-ups of numbness, vision loss and other problems that can last weeks or months.

Campath reduced the number of attacks by 74 percent compared to Rebif and reduced the risk of disability worsening by 71 percent.

More startling, Cole said, was that after three years people on the experimental drug showed better coordination, walked more quickly and had less brain tissue damage.

"The most remarkable thing is if you look at the disability of all the patients at the end of the treatment, the people on the standard treatment were more disabled," he said.

"The patients on alemtuzumab have an increase in brain volume, which means the brain is repairing itself."

The researchers did not compare the drug directly to Tysabri but based on existing data said they believe alemtuzumab is a more effective and safer treatment.

Tysabri is widely considered the most effective MS drug on the market, but its use has been crimped due to safety concerns.

Campath was first used in humans in the early 1980s to treat a form of leukemia. It is a monoclonal antibody, a lab-engineered immune system protein that attacks specific targets -- in this case white blood cells that cause damage to the myelin sheath around nerves.

Without this protection, the nerves are like bare wires that fuse together and short-circuit, leading to brain damage and producing symptoms of the disease, Cole said.

The drug, however, only works for people with early stage MS and also carries risks of serious but treatable side effects that included thyroid dysfunctions and a fatal blood condition.

Cole said the drug, about to go into final Phase III clinical trials, could hit the market in four years and could be a candidate for fast-track treatment from regulators.

"Whether or not alemtuzumab itself ends up on the market, this study will still be a landmark study showing you can improve the disability of people with multiple sclerosis if you treat it early enough and aggressively."

"The point to me is we've drawn a line in the sand. We are in a new era and we can reverse disability."

(Additional reporting by Toni Clarke; Editing by Maggie Fox and Paul Bolding)"

[SallyC]

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

[weegot5kiz]

yes read it this morning Volada posted it here

http://neurotalk.psychcentral.com/thread57547.html

very interesting wonder how far gone with ms u can or can not be for it to be of help, any good news is good for those with MS

[SallyC]

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

Campath®
(alemtuzumab) Injection for Intravenous use

WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS

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.

[lady_express_44]

"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

[Niko]

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