TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI) today announced that the Company and leading physicians from Johns Hopkins University co-hosted a meeting with prospective clinical trial investigators at the recent American Academy of Neurology (AAN) Annual Meeting in New Orleans. The Company and investigators from Johns Hopkins University 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.
A group of invited key opinion leaders and neurologists from leading Multiple Sclerosis Centers of Excellence attended the Cyrevia investigators meeting, hearing presentations from two Johns Hopkins physicians: Douglas E. Gladstone, M.D., Associate Professor of Oncology, Clinical Director In-patient/Out-patient Program (IPOP), Sidney Kimmel Comprehensive Cancer Center; and Daniel M. Harrison, M.D., 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-center 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 & 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.
About Accentia Biopharmaceuticals, Inc.
Headquartered in Tampa, Florida, Accentia Biopharmaceuticals, Inc. (OTCQB: “ABPI”) is committed to advancing the autoimmune disease therapy, Cyrevia™ (formerly Revimmune™), as a comprehensive system of care and drug regimen designed for the treatment of autoimmune diseases. Cyrevia therapy includes an ultra-high-dose regimen of Cytoxan® (cyclophosphamide), exclusively supplied via a strategic agreement with Baxter Healthcare Corporation. Clinical trials for Cyrevia are being planned for the treatment of multiple sclerosis and the prevention of graft-versus-host disease following bone marrow transplant.
Accentia holds a majority-ownership stake in Biovest International, Inc. (OTCQB: “BVTI”), an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific cancer vaccine, BiovaxID®, with three clinical trials completed, including a Phase III study for the treatment of follicular non-Hodgkin’s lymphoma.
For further information, please visit: http://www.Accentia.net
Special Note: Accentia is currently designing a new corporate and Cyrevia website.
Forward-Looking Statements:
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune™, BiovaxID® and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.