Re Clinical Trials

RNS Number:4490T
M.L. Laboratories PLC
19 December 2003



19 December 2003                                           Embargoed until 0700

                  ML'S DENDRITIC CELL VACCINE TREATMENT STARTS
                     PHASE I CLINICAL TRIAL IN SKIN CANCER

ML Laboratories PLC ('ML') announces that its collaborators at the Cancer
Research UK Institute for Cancer Studies at Birmingham University have entered
the first patient in a Phase I clinical trial in which a vaccine comprised of
the patients immune cells transfected with ML's proprietary antigen delivery
system, CL22, will be used to treat advanced melanoma.

The vaccine uses the patient's own dendritic cells, which are powerful immune
cells that educate the body's killer cells to destroy foreign cells or cells
infected with foreign invaders. CL22 is a synthetic peptide that binds to DNA
encoding the tumour associated antigens and enables efficient loading of
dendritic cells with these antigens.

In the trial, dendritic cells that have been previously isolated from the
patient's blood are modified using CL22 so that when they are returned to the
patient by injection they are able to induce the patients immune system to
recognise and destroy the cancer cells.

The objectives of the study are to establish the safety of the treatment and to
assess anti-tumour effects. The duration of the treatment is 3 months and the
study is expected to report in approximately one year subject to patient
recruitment.

Pre-clinical data suggest that this treatment will specifically attack skin
cancers as well as the cancerous cells which leave the tumour and spread the
disease throughout the body.

Harnessing the body's immune system is a promising approach to disseminated
cancer, because of the ability of killer immune cells to attack tumours all over
the body and to kill them in a very specific fashion. The use of dendritic cells
modified ex vivo with tumour associated antigens promises to give a potent
anti-tumour immune response.

Professor Lawrence Young, Head of the Cancer Studies Institute and in overall
charge of the clinical trial said: "The initial plan is to recruit 10 patients
with melanoma that has advanced beyond the skin and look for signs that the
treatment has activated immune cells to attack the cancer. We are pleased to
extend our fruitful collaboration with ML with whom we are already conducting
gene therapy clinical trials in patients with prostate cancer".

Dr. Andy Mountain, Director of Research for ML commented: "This initial trial of
CL22, ML's proprietary gene delivery system, is a physician sponsored trial
involving a small number of melanoma patients.

"The CL22 system is a platform technology which could be used to modify
dendritic cells for the treatment of many other advanced forms of cancer for
which no effective treatments are available, such as prostate and liver cancer.
If the melanoma trial is successful, ML will be seeking partners interested in
using the technology to develop dendritic cell vaccines for a range of life
threatening diseases".

According to the World Health Organisation, 132,000 patients worldwide are
diagnosed with melanoma each year and the incidence is growing. Although
patients with localised melanoma can often be cured there are no really
effective treatments for those with the more advanced, disseminated form of the
disease, which is the most difficult form of skin cancer to treat. Worldwide
sales of malignant melanoma products exceeded $250M in 2000 (Source: Decision
Resources).

Note to editors

Existing Treatments

Localised cancers of many types can be treated quite successfully by surgery or
radiotherapy, but once the disease has become more widely disseminated there
are, at present, very few cancer types for which there are effective treatments
resulting in cures or substantial improvements to life expectancy.
ML Laboratories

ML Laboratories PLC 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

- Ends -

For further information please contact:

ML Laboratories PLC - 01925 844700
Stuart Sim

Weber Shandwick Square Mile - 020 7067 0700
Kevin Smith/Cass Helstrip






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