Biovest Secures Worldwide Exclusive License to Late-Stage Technology for Elimination of Transplant Rejection

Business Wire, Jan 22, 2008

Published Study Shows Revimmune[TM] Reduces the Incidence of Chronic Bone Marrow Transplant Rejection of Host by Approximately 85%, Enabling Bone Marrow Transplant Usage to Cure Chronic Illnesses such as Sickle Cell Anemia

TAMPA, Fla. -- Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), announced today that it has secured the worldwide, exclusive license to Revimmune[TM] for the treatment and prevention of transplant rejection including rejection following a bone marrow transplant. As an initial indication, the Company intends to submit an Investigational New Drug (IND) application seeking Food and Drug Administration (FDA) permission to enter a Phase 3 clinical trial of Revimmune usage in bone marrow transplants to treat and possibly cure sickle cell anemia, an inherited disease that is chronic and lifelong, leading to painful crises, organ failure, and strokes. The average lifespan of an individual with sickle cell anemia is approximately 42 years.

Revimmune is a patent-pending pharmaceutical treatment in late-stage development for the prevention of transplant rejection, with applications to bone marrow transplants for a wide variety of indications including elimination of sickle cell anemia, and other hereditary hemoglobinopathies such as thalassemia.

According to Biovest's Chairman and CEO, Dr. Steven Arikian, "Rejection is frequent in bone marrow transplants, as the transplanted immune system from the donor attacks the organs of the transplant recipient, and many life-threatening complications occur. With the acquisition of Revimmune for transplant rejection, we obtain a product that we believe can improve the percentage of successful transplants, as evidenced by its ability to dramatically reduce the incidence of chronic Graft-Versus-Host Disease (GVHD) in bone marrow transplants." GVHD is a particularly severe type of transplant rejection characterized by the donor marrow (graft) producing immune cells that attack multiple organs of the recipient (host).

In clinical studies at Johns Hopkins University Medial Center for treatment and prevention of transplant rejection including rejection following a bone marrow transplant, more than 200 patients have been treated with Revimmune. In a group of 46 bone marrow transplant patients(1), the use of Revimmune is associated with a reduction in the incidence of chronic bone marrow transplant rejection of the recipient by approximately 85%. In particular, transplant patients who received Revimmune had an incidence of just 11% of chronic GVHD, in contrast to an incidence of 75% in patients engrafted without Revimmune. Accordingly, Revimmune has the potential to be the first effective treatment of this life-threatening complication.

Dr. Arikian explained another key reason why Revimmune may be ideal for use in bone marrow transplants to cure sickle cell anemia, "While bone marrow transplant offers the only potential cure for sickle cell anemia, very few people have a suitable donor for transplant. Another expected advantage of Revimmune is that its use expands the potential pool of transplant donors by reducing the requirement for tissue matching, overcoming a major obstacle of treatment."

The technology is being licensed to Biovest for transplant rejection from Revimmune, LLC, a Hopkins Capital Group II LLC (HCG II) portfolio company, which holds the exclusive license for the technology from the Johns Hopkins University. Revimmune, LLC has previously licensed the exclusive, worldwide rights to Revimmune for treatment of all autoimmune diseases to Accentia Biopharmaceuticals. Dr. Frank E. O'Donnell Jr. is a managing partner of HCG II. More details of the license can be found in the Company's 8-K filing. HCG II is not affiliated with the Johns Hopkins University.

Revimmune for Prevention of Graft-Versus-Host Disease

The principal investigator for the ongoing Revimmune study in bone marrow transplant patients at Johns Hopkins University School of Medicine is Dr. Richard Jones. Dr. Jones, Dr. Leo Luznik and colleagues presented results of the study(1) at a recent meeting: Post-Transplantation High-Dose Cyclophosphamide (Cy) Is Effective Single Agent GVHD Prophylaxis That Permits Prompt Immune Reconstitution after Myeloablative HLA Matched Related and Unrelated Bone Marrow Transplantation (BMT).

Dr. Jones and Dr. Luznik concluded that the results of the study indicate that post-transplantation Revimmune (high-dose cyclophosphamide) is effective as a single agent strategy for limiting acute and chronic GVHD after myeloablative HLA-matched related and unrelated allografting; this approach also limits the need for prolonged immunosuppression, resulting in favorable immunoreconstitution with few opportunistic infections in this unfavorable group of patients.

Graft-versus-host disease is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack.