Genzyme expects to complete a Phase II trial of Campath in multiple sclerosis patients under a risk management plan that FDA could release in the first half of the year, CFO Michael Wyzga said May 18 during the Bank of America Healthcare Conference.

"Once we develop a safety profile with the FDA, and that will be forthcoming probably in the first half of this year...and then we'll move [the Phase II] trial along," he said.

Genzyme and Schering AG suspended dosing in the alemtusumab trial in MS last September after three patients developed severe idiopathic thrombocytopenia purpura, one fatally. Two of the ITP cases occurred in the high-dose Campath group; the companies have decided not to pursue that strength (¹ Also see "Genzyme/Schering AG To Initiate Campath Phase III Trial For MS" - Pink Sheet, 16 September, 2005.).

FDA issued an alert concerning cases of ITP related to Campath in November (² Also see "FDA Alert Warns Of Adverse Events With Genzyme/Schering AG's Campath" - Pink Sheet, 30 November, 2005.).

Although Genzyme/Schering AG halted dosing in the trial, the companies continued to collect safety and efficacy data and expect to have Phase II data available in the second half of the year, the firm said.

All patients in the 334-patient randomized trial were dosed initially with one of two strengths of once-a-year intravenous infusion of Campath or Serono's Rebif (interferon beta-1a) administered three times per week. In a one-year follow-up treatment, all but two patients were dosed, Genzyme said.

A Phase III trial of Campath in MS is expected to initiate in the second half of the year, Wyzga said. He pointed out that one challenge for the trial, which will include a treatment regimen of five injections followed by a three-injection booster after one year, will be monitoring safety.

"The real key to me will be how do you monitor that on a safety basis," he said. "If somebody feels well, how do you bring them back on a weekly basis to check into it?"

The path to registration should be straightforward, given the comparison of Campath to Rebif, Wyzga said. "If the Phase II data holds, it's very strong data," he added.

- Jessica Merrill

Genzyme’s Campath MS Safety Profile Expected From FDA By July; Phase III Set For Second Half

More from Archive

More from Pink Sheet