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NORWOOD IMMUNOLOGY LIMITED

(‘Norwood Immunology’ or 'the Company')






CLINICAL STUDY RESULTS – BONE MARROW TRANSPLANT TREATMENT



STUDY COMPLETE, CONFIRMS PREVIOUS POSITIVE DATA



Norwood Immunology Limited (AIM: NIM), the company focussed on the rejuvenation of the immune system, today announces the completion of the pilot clinical study in cancer patients undergoing chemotherapy and bone marrow transplantation (BMT). The study was used to determine whether a luteinising hormone releasing hormone (LHRH) agonist can enhance the renewal of T cells, which are essential for immune defence mechanisms. Analysis of the additional data shows positive results and a significant increase in naïve CD4+ T cells and further supports 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 immunosuppressed patients, and so confirm the effects previously demonstrated pre-clinically and in prostate patients, by the Company. A major problem for BMT patients is that the standard of care chemotherapy also causes permanent damage to the immune system. While children recover adequate immunity from approximately 6 months post BMT, adults rarely regain specific immune defence mechanisms. 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, which was conducted at in 83 patients, aged 18 years or older, with either leukaemia, lymphoma or multiple myeloma (40 treated; 43 control) was carried out for approximately 13 months in male or female patients at the Alfred Hospital and Peter MacCallum Cancer Institute in Melbourne. Patients 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, The primary endpoint was to determine whether the LHRH agonist could induce renewed thymic function and output of new naïve 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 results of the study are currently being fully analyzed and a manu-script prepared for submission to a peer reviewed journal. Analysis of the key data however, demonstrated a significant increase in naïve 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 fully randomised, placebo controlled, 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 lead the way to this FDA accepted study, which is being conducted in conjunction with our US licence partner, TAP Pharmaceutical Products Inc, our Principal Investigator and other leading clinicians.”



For further information please contact:


Richard Williams, Chief Executive Officer, Norwood Immunology Limited
+44 (0) 7860 295153

Lisa Baderoon, Mark Court, Mary-Jane Johnson, Buchanan Communications
+44 (0) 207 466 5000

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® (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® (lansoprazole). For more information about TAP and its products, please visit the company’s web site at www.tap.com.