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شنبه 5 بهمن 1387 ساعت 15:26 |
Jan 23, 2009
این هم داروی دیگر خوراکی ام اس که در مطالعات فاز 3 بسیار موثر بوده و بزودی روانه بازار می گررد .
Oral Cladribine (Mylinax) Reduces MS Relapses in Phase 3 Clinical Trial
Oral cladribine (Mylinax, Merck Serono) reduced the relapse rate significantly more than inactive placebo in the phase 3 "CLARITY" study of 1,326 people with relapsing-remitting MS. These initial results - the first from any phase 3 study of oral therapy for MS
Oral cladribine (Mylinax, Merck Serono) reduced the relapse rate significantly more than inactive placebo in the phase 3 "CLARITY" study of 1,326 people with relapsing-remitting MS. These initial results - the first from any phase 3 study of oral therapy for MS -- are reported in a press release from Merck Serono dated January 23, 2009. Additional study results will be submitted for presentation at an upcoming scientific meeting. Oral cladribine has been designated by the U.S. Food and Drug Administration as a "Fast Track Product," which should expedite its future review. The company plans to file for FDA approval of oral cladribine in mid-2009.
Background: Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. Injectable cladribine is used to treat hairy cell leukemia. Studies have suggested a benefit in MS. In addition to the completed CLARITY study, other ongoing studies of oral cladribine funded by Merck Serono include:
· The ONWARD study, an investigation of the safety and effectiveness of adding high or low doses of oral cladribine to Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer) in a trial recruiting 260 people with relapsing forms of MS (this study is currently recruiting participants); and
· The ORACLE MS study, designed to evaluate the safety and effectiveness of oral cladribine in people who have experienced a neurological episode that puts them at risk for developing MS (this study is currently recruiting participants).
The CLARITY Study: For the first year of the study, 1,326 participants were randomly assigned to receive a low dose of cladribine (two treatment cycles per year, each cycle consisting of one tablet per day for four to five consecutive days), a high dose (four cycles) of cladribine, or inactive placebo. In the second year, both treatment groups received a low dose of cladribine. The primary endpoint was the drug's effect on relapse rate at two years compared with placebo. Secondary endpoints included effects on disease activity, as detected by MRI scans, the proportion of relapse-free participants, and disability progression.
The relapse rate was reduced significantly more than placebo in both treatment groups (by 58% in the low-dose group and by 55% in the high-dose group). The company reports that secondary endpoints of the CLARITY study were also met, although the details of these are not provided in the press release. Additional study results will be submitted for presentation at an upcoming scientific meeting.
Lymphopenia - a reduction of white blood cells - was the most frequent adverse event, and occurred more frequently in the groups on cladribine. Other adverse events reported in all three groups were headaches and cold symptoms.
"These are exciting initial results, and we look forward to seeing the full data," says John Richert, MD, Executive Vice President of Research and Clinical Programs at the National MS Society. "If this pill proves to be safe and effective for people with relapsing MS, it represents a major treatment breakthrough - hopefully the first of many more in the pipeline."
Rebif is a trademark of EMD Serono Inc. and Pfizer |
