Norwood Immunology Completes Melbourne BMT Clinical Trial.

MELBOURNE, Australia -- Norwood Abbey Ltd (ASX:NAL):

Key points:

--Cancer trial at Alfred Hospital & Peter MacCallum Cancer Institute completed

--Data support previous positive interim results

--Multi-centre FDA approved study now underway at leading US cancer centres

Norwood Abbey Ltd (ASX:NAL) advises that its subsidiary Norwood Immunology Limited (AIM:NIM), the company focussed on the rejuvenation of the immune system, has announced the completion of the Melbourne pilot exploratory clinical study in cancer patients undergoing chemotherapy and bone marrow transplantation (BMT). The study sought to determine whether an LHRH agonist can enhance recovery of T cells, which are essential for immune defence mechanisms. Analysis of the data support the interim results as previously announced at the American Haematology Society conference in December 2003.

This non randomized, open labelled study was initiated to explore whether the Company's technology was safe to use and could enhance immune recovery in immuno-suppressed patients, and so confirm the effects previously demonstrated pre-clinically and in prostate patients, by Norwood. A major problem for BMT patients is that the standard of care chemotherapy also causes collateral ablation of the immune system. While children recover adequate immunity from approximately 6 months post BMT, adults rarely regain specific immune defence mechanisms even after 2 years, because of the profound degeneration of thymus function from puberty and associated reduction in new T cell output. This immune suppression of BMT leads to high incidence of infections, and may underlie cancer relapse and poor responses to vaccines including those to cancer.

The study was conducted in 83 patients with either leukaemia, lymphoma or multiple myeloma (40 treated; 43 control) enrolled at the Alfred Hospital and Peter MacCallum Cancer Institute. They received standard of care cancer high-dose myeloablative chemotherapy, with or without a course of an LHRH agonist and either autologous (self derived) or allogeneic (from a donor) BMT (also known as haematopoietic stem cell transplant). The primary endpoint was to determine whether the LHRH agonist could induce renewed thymic function and output of new naive CD4+ T cells (which are required for all immune responses), compared to similar patients not receiving the LHRH. Secondary endpoints included extensive analysis of other immune cells in the blood.

The trial was open to male and female patients aged 18 years or older. Study participants in the treatment group received 4 months of therapy with an LHRH agonist and all patients were on study for approximately 13 months.

The results of the study are currently being fully analyzed and a manuscript prepared for submission to a peer reviewed journal. Analysis of the key data however, demonstrated a significant increase in naive CD4+ T cells and CD4+ TRECs, confirming the interim results reported previously.

Principal Investigator, Associate Professor Anthony Schwarer, Head, Bone Marrow Transplant Programme, Alfred Hospital commented: "Many patients become seriously immune compromised as a result of the transplant regime, and a treatment that will improve recovery and reduce post-transplant infections would be important. The results of this exploratory study are encouraging. Even though we had a mixed patient group with different prognostic outcomes and the patients were not randomized, the effect we saw on the increase of CD4+ T cells numbers and TRECS is a world first. It will be important to now confirm and even quantitate if possible, this rate of immune recovery and its clinical benefits in an adequately powered double blind, placebo controlled study in a more homogeneous patient population/group."

Richard Williams, CEO of Norwood Immunology, commented: "Completing this study is an important milestone for the Company. The early results and the foundation work established by this exploratory study has also enabled Norwood Immunology to develop a well thought out, high quality multi-centre study which opened at the MD Anderson and Dana-Farber Cancer Institute in the USA earlier this year. We are pleased that our Australian study, championed by Associate Professor Tony Schwarer, has led the way to this FDA approved study, which is being conducted in conjunction with our US licence partner, TAP Pharmaceutical Products Inc., our Principal Investigator and other leading clinicians."

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.

To find out more about the Norwood group, visit www.norwoodabbey.com and www.norwoodimmunology.com.