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Norwood Abbey Announces Phase II Clinical Trial in Cancer Patients Commences

Posted on: Wednesday, 22 February 2006, 15:00 CST

Norwood Abbey Ltd (ASX:NAL):

Key points:

-- Phase II trial commences in cancer patients undergoing autologous bone marrow transplant treatment

-- Trial led by Principal Investigator Professor Richard Champlin, Professor and Chair, Blood and Marrow Transplantation Department, M.D. Anderson Cancer Center

-- Study opened - first patient recruited

Norwood Abbey Ltd (ASX:NAL) advises that its subsidiary Norwood Immunology Ltd (AIM:NIM), the company focussed on the rejuvenation of the immune system, announces the commencement of the Phase II clinical trial in cancer patients undergoing autologous (self-derived) bone marrow transplant (BMT). This follows the Company's previous announcement updating progress toward commencement on 4 July 2005.

The first of the 80 patients (40 treated; 40 control) has been enrolled at University of Texas, M.D. Anderson Cancer Center, of Houston, and will be randomized to receive either Lupron Depot(R) or placebo. The Dana-Farber Cancer Institute, Harvard Medical School, Boston and University of Minnesota Medical Center, Fairview, study sites are expected to commence recruitment shortly.

This double blind randomized Phase II clinical trial, which has been accepted by the U.S. Food and Drug Administration (FDA), is being undertaken to determine whether there is enhanced immune recovery as a result of using the Company's technology. It is being conducted in patients receiving standard of care high dose myeloablative chemotherapy therapy and autologous bone marrow transplant (also known as haematopoietic stem cell transplant) for the treatment of Hodgkin's disease, non-Hodgkin's lymphoma or multiple myeloma. Adult patients normally have very poor immune recovery following such chemotherapy treatment.

The primary endpoint of the trial is T cell response to a neo-antigen vaccine, as an indicator of enhanced immune response. Secondary endpoints include responses to 3 common vaccines and extensive analysis of T cells and other immune cells in the blood. The trial design is based on the pilot study conducted by Norwood Immunology at the Alfred Hospital and Peter McCallum Cancer Institute in Melbourne, Australia, interim results of which were announced at the American Haematology Society conference in December 2003.

The trial is open to male patients aged 18 to 60 years old and female patients aged 18 to 50 years old. Study participants will receive 9 months of therapy with Lupron 3 Month Depot(R) or Placebo, and will be on study for approximately 13 months. Information on the trial is available at the National Institutes of Health clinical trial database at http://www.ClinicalTrials.gov.

The study Chairperson, Professor Richard Champlin, Professor and Chair, Blood and Marrow Transplantation Department at M.D. Anderson Cancer Center, has developed this study in a collaborative effort with a consortium of other leading clinicians and pre-eminent institutions in the field of cancer, including both the Dana-Farber Cancer Institute and the University of Minnesota. This consortium, co-funded by the National Cancer Institute and the National Institute of Allergy and Infectious Diseases is led by Dr Lee Nadler, Senior Vice President, Experimental Medicine, Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School.

Norwood Immunology and its US licence partner, TAP Pharmaceutical Products Inc. (TAP), who market Lupron Depot(R) in the USA are collaborating with the consortium in this effort. TAP is the FDA Investigational New Drug (IND) holder for this trial. It is being conducted in accordance with the ICH Good Clinical Practice Guidelines.

Professor Richard Champlin of M.D. Anderson Cancer Center commented, "We see many patients seriously immune compromised as a result of the transplant regime, and a treatment that will improve recovery and reduce post-transplant infections is much needed. We are excited to be the involved in this study, as this is a promising treatment which, if effective, would be the first treatment to effectively stimulate recovery of immunity in stem cell transplant patients."

Dr Lee Nadler, Senior Vice President, Experimental Medicine, Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School commented, "The consortium, TAP and Norwood are delighted to be working closely on this exciting clinical study. The contribution of the partners in the development of this project has generated a well thought out study design and shows what a truly committed industry - institute collaboration can accomplish. Together with the research teams at MD Anderson and University of Minnesota, we hope to make great strides in our understanding of the effects of Lupron in immune recovery. We are truly excited to embark on this novel and extremely important study."

Richard Williams, CEO of Norwood Immunology, commented, "Commencing this study is an important milestone for the company. I am pleased that we are now underway and appreciate the hard work of the teams at Dana Farber, M.D. Anderson, University of Minnesota and TAP in working closely with us to design and implement this high quality, and complex study."

To find out more about Norwood Abbey, visit www.norwoodabbey.com or www.norwoodimmunology.com

Notes for editors:

Norwood Immunology has licensed its immunology intellectual property to TAP Pharmaceutical Products Inc. for commercialization in the United States, utilizing TAP's GnRH analogue, Lupron Depot(R) (leuprolide acetate for depot suspension). This combined initiative is exploring the use of Lupron Depot in regenerating the thymus gland and in turn "re-booting" the body's immune system, enabling patients to better recover from life-threatening diseases.

TAP Pharmaceutical Products Inc., located in Lake Forest, IL., U.S.A., is a joint venture between Abbott, headquartered in Abbott Park, IL., U.S.A ., and Takeda Pharmaceutical Company Limited of Osaka, Japan. TAP currently markets Lupron Depot and Prevacid(R) (lansoprazole). For more information about TAP and its products, please visit the company's web site at www.tap.com.

Source: Business Wire

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