Genzyme and Isis Begin Second Phase 3 Trial Of ...(ble-blind placebo-controlled study takin...),Health

Date:8/6/2008

ble-blind, placebo-controlled study taking place at approximately 30 sites in the U.S. and Canada, with an anticipated total enrollment of around 100 patients. Patients on a stable dose of other lipid-lowering agents are being randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. The primary endpoint will be percent reduction in LDL cholesterol, and data are expected to be available in 2010. The trial will add to the body of clinical data on mipomersen and the overall product profile.

"This is an exciting moment for mipomersen, combining the initiation of the phase 3 trial in heFH with a very broad patent allowance that expands the patent coverage for the apoB franchise," said Stanley Crooke, chairman and chief executive officer of Isis. "This comprehensive patent covers methods of inhibiting apoB by targeting anywhere on the messenger RNA including the site to which mipomersen binds, and all therapeutic uses that might result from lowering apoB."

Mipomersen Development Plan

The initial indication sought for mipomersen will be for patients with homozygous FH, and enrollment in a phase 3 trial in this patient population is expected to be completed by the end of this year. Data are expected to be available in mid-2009 and a U.S. filing for this indication is anticipated during the second half of 2010.

Genzyme and Isis plan to begin three additional trials evaluating mipomersen's safety and efficacy in reducing LDL cholesterol in high-risk patients during the second half of 2008. These trials will include: one for apheresis-eligible patients, and two for high-risk, high cholesterol patients. All three have anticipated trial designs that include a 2:1 randomization ratio of a 200 mg dose of mipomersen or placebo weekly for 26 weeks.

These trials will continue to build the body of clinical evidence around mipomersen's value in managing very high risk patients. Data from the trials will also inform the des
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SOURCE Genzyme Corp.; Isis Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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