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Genzyme Corp. has reported that a Phase 3 trial for its multiple sclerosis drug target, alemtuzumab, is now fully enrolled. The Cambridge-based biotechnology company also announced positive results from a four-year follow-up study on patients in its Phase 2 study for the drug.
Genzyme officials said alemtuzumab continued to show durable reductions in the rate relapse and the rate of sustained accumulation of disability three years after the majority of patients received their last course of the drug candidate. The Phase 2 trial compared alemtuzumab to an approved MS therapy called Rebif in patients with an early form of the disease who had received no prior therapy.
“These findings confirm the extended duration of response observed in our pilot studies with alemtuzumab in patients with relapsing MS,” said Alasdair Coles, a lead investigator of the Phase 2 clinical trial, in a prepared statement.
In the trial, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three times per week, every week for three years.
The four-year analysis found that patients taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 72 percent and the risk of sustained accumulation of disability by 73 percent compared to patients treated with the active comparator Rebif. These data closely mirror three-year findings, which were reported in the New England Journal of Medicine last year.
The company also announced that the second of two Phase 3 trials of alemtuzumab in the treatment of MS has completed enrollment.
The company plans to send the drug candidate to the FDA in 2011.
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