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URL http://www.rockymountainbmt.com/news/AnorMED-completes-enrollment-in-phase-III-trial-for-Mozobil-2329.html

AnorMED completes enrollment in phase III trial for Mozobil

08-09-2006

AnorMED, Inc., (AOM; AOM) announced that enrollment has been completed for one of two pivotal phase III trials being conducted with Mozobil for stem cell transplant.

The multiple myeloma (MM) trial reached its target enrollment having enrolled 300 patients. Recruitment continues for the second phase III trial in non-Hodgkin lymphoma (NHL), having enrolled 241 of the targeted 300 patients. The two phase III trials are evaluating Mozobil in a standard stem cell mobilization regimen.

In accordance with the trial design that is subject to the terms of a Special Protocol Assessment with the FDA, the most recently enrolled patients will undergo their transplants over the next 4-6 weeks with a subsequent 100 day follow-up period required. The MM trial design also allows physicians to request, upon enrollment, that a patient has the option to have a second or "tandem" transplant should they not go into complete remission.

Physicians have up to 6 months from the first transplant to perform a second transplant if required. The 100 day follow-up period would then commence from the date of the second transplant. The results of the study will be unblinded once all patients enrolled have completed their 100 day follow-up. This tandem option is not available in the NHL trial.

"We are pleased to have completed enrollment in our first phase III trial within our originally stated timelines. The next major milestone is the completion of enrollment of the NHL trial and then the announcement of topline data for both phase III trials which is planned by the second quarter of 2007," said Gary Calandra, VP Clinical Development, AnorMED, Inc.

Mozobil is a stem cell mobilizer used in stem cell transplants, a procedure used to restore the immune system of cancer patients who have had treatments that previously destroyed their immune cells. Mozobil works by triggering the rapid movement of stem cells out of the bone marrow and into circulating blood. Once in the circulating blood, the stem cells can be collected for use in a stem cell transplant. In phase II studies, Mozobil consistently demonstrated the ability to help cancer patients collect more of their own stem cells, resulting in an increase in the potential for these patients to be able to undergo a stem cell transplant.

Mozobil is currently the subject of two phase III clinical studies at up to 45 major centres in the U.S., Canada and Europe involving 600 cancer patients with either NHL or MM and who are undergoing autologous stem cell transplantation as a part of their treatment. Both phase III studies are randomized, double-blind, placebo-controlled, comparative trials of Mozobil plus G-CSF versus placebo plus G-CSF, the current standard drug used to stimulate additional stem cells within bone marrow.

The company expects to complete patient recruitment of the second phase III study by the end of 2006 and announce top-line results from both studies by the second calendar quarter of 2007. If successful, the results of these clinical studies would be the basis for filings in the United States, Canada, the E.U. and other countries seeking approval to market Mozobil for these indications.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2006, Biotech Business Week via NewsRx.com.