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RNS Number:7119R M.L. Laboratories PLC 05 November 2003 Embargoed until 13.00 5 November 2003 ML COMMENCES TREATMENT STAGE OF PHASE II CLINICAL TRIAL OF NOVEL TREATMENT OF PROSTATE CANCER ML Laboratories PLC ("ML") announces the commencement of the treatment stage of its Phase II clinical study of its novel treatment of prostate cancer. The trial is the first of its kind in prostate cancer in the UK. The new technique being pioneered in the trial uses gene therapy technology to deliver a cancer killing toxin direct to the tumour site in a two stage process. The first stage of the process is to utilise a well established technique to inject prostate tumours with a harmless virus containing the ntr gene. Once inside the cancer cell this gene produces a particular protein enzyme called nitroreductase. The second stage is to inject the patient intravenously with a non-toxic prodrug which is converted in the tumour by the nitroreductase enzyme into the active drug that kills the cancer cells while leaving other cells unaffected. The object of the study is to determine that the treatment is both safe and efficacious the latter being measured by the reduction in the blood level of prostate specific antigen (PSA). We expect to report the outcome of the trial in the first half of 2005. In the previous phase of the trial conducted at the Queen Elizabeth Hospital, Birmingham and the Freeman Hospital, Newcastle-upon-Tyne, in fifteen patients with locally-recurring prostate cancer, it was shown that the injection of virus direct into prostate tumours is a safe and effective method of targeting cancer cells and can lead to generation of the nitroreductase enzyme in those cells. Professor Donald Davies, Group Director of R&D at ML said: "We are encouraged by the progress made in the first stage of the trial which has shown the ntr virus to be safe and well tolerated. We are now entering the therapeutic phase of the study and are hopeful that this new approach will deliver an innovative treatment for prostate cancer sufferers." Professor Nicholas James, Professor of Oncology at the University of Birmingham is leading the study and said: "We have reached an important milestone in the early phase of this trial and now are delighted to be leading the field of gene therapy in prostate cancer studies in the UK. We have shown that the injection of viruses into prostate tumours is a safe and effective way to target cancer cells, and our discovery that the enzyme produced may then facilitate the killing of these cells has positive and wide ranging implications This study may lead to a real treatment." Prostate cancer is the most common cancer in men in the UK, with over 24,700 new cases a year. The lifetime risk for being diagnosed with prostate cancer is 1 in 14*. ML holds the license to the virus containing the ntr gene, which was developed at the University of Birmingham's Cancer Research UK Cancer Studies Institute in the mid-1990s. * Source: Statistics from Cancer Research UK - Ends - For further information please contact: ML Laboratories PLC John Wynne, Director of Business Development 01782 382208 ML Pharmaceuticals Stuart Sim, Executive Chairman 01925 844700 Weber Shandwick Square Mile 020 7067 0700 Cass Helstrip Note to Editors: ML is a pharmaceutical product development company with a track record of successful clinical development, regulatory approval and licensing of pharmaceutical products and a pipeline of future products targeted at specialist markets. ML's activities are supported by a growing income stream from marketed products it has successfully developed and licensed to other pharmaceutical companies, which include Baxter, Shire and Celltech. New therapeutic products in clinical development include cancer treatments, a pain management compound prepared to enter Phase III studies, a preventative of sexually transmitted infections, including HIV, and a phosphate binder to assist the management of kidney failure. ML's portfolio of early stage development projects includes unique polymer/drug molecules to provide safer and more potent cancer chemotherapy and technologies for use in the discovery and manufacture of biotechnology products. In addition ML provides inhaled drug delivery solutions to the global pharmaceutical industry through its dedicated respiratory subsidiary Innovata Biomed. More information about ML Laboratories PLC can be found at www.mllabs.co.uk This information is provided by RNS The company news service from the London Stock Exchange END RESUUGUCGUPWGPA
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