The leading physicians from Accentia Biopharmaceuticals, Inc. and Johns Hopkins University have presented plans for a randomized clinical trial to study Cyrevia (formerly Revimmune) in multiple sclerosis (MS) to a number of key opinion leaders in the field and potential site investigators. Johns Hopkins University will serve as the lead trial site for the study.

Physicians also co-hosted a meeting with prospective clinical trial investigators at the recent American Academy of Neurology (AAN) Annual Meeting in New Orleans.

A group of invited key opinion leaders and neurologists from leading Multiple Sclerosis Centres of Excellence attended the Cyrevia investigators meeting, hearing presentations from two Johns Hopkins physicians: Douglas E Gladstone, MD, associate professor of Oncology, clinical director in-patient/out-patient programme (IPOP), Sidney Kimmel Comprehensive Cancer Centre; and Daniel M Harrison, MD, assistant professor of Neurology. Drs Gladstone and Harrison reviewed multiple open-label phase II Cyrevia studies conducted at Johns Hopkins, demonstrating significant benefit for Cyrevia versus historical outcomes in the treatment of a range of autoimmune diseases, and jointly proposed a controlled, randomized, multi-centre phase III MS study.

“It was a great privilege to hear positive feedback from such an esteemed group of leading MS physicians, and we look forward to making a formal announcement as to the institutions that will participate in our planned Cyrevia clinical trial,” stated Samuel S Duffey, Esq., Accentia’s president and CEO. “In particular, we found tremendous enthusiasm for a single course of Cyrevia therapy administered over four consecutive days that offers patients the potential to 'reboot' their immune system in order to reduce their disability.”

As a novel system of care to treat multiple sclerosis, Cyrevia (high-dose Cytoxan or “HiCy”) temporarily, but almost completely, eliminates circulating white blood cells, including autoimmune disease cells, while sparing the immune stem cells in the bone marrow. Following Cyrevia, the immune system reforms, only with new white blood cells derived from these stem cells, in effect “rebooting” itself and reestablishing an immune system without a large population of autoimmune cells. Cyrevia therapy includes a comprehensive risk management program (REMS) to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.

Accentia Biopharmaceuticals Inc. is committed to advancing the autoimmune disease therapy, Cyrevia as a comprehensive system of care and drug regimen designed for the treatment of autoimmune diseases.