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

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