RNS Number:4599T
Alizyme PLC
19 December 2003


For Immediate Release                                          19 December 2003


                ALIZYME GRANTED CTX FOR PHASE IIa CLINICAL TRIAL
                            FOR ATL-104 FOR MUCOSITIS

Cambridge UK, 19 December 2003: Alizyme plc (LSE:AZM) announces today that it
has been granted regulatory permission in the form of a CTX (see Editor's Note)
from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to
undertake a Phase IIa clinical trial to evaluate ATL-104 for the treatment of
mucositis.

The approval is for a randomised, double-blind trial comparing three doses of
ATL-104 with placebo, in patients undergoing ablative therapy prior to
autologous bone marrow transplantation for the treatment of leukaemia and/or
lymphoma. Patients will be treated for six days around the initiation of
ablative therapy to destroy their cancer and bone marrow. The objectives of the
study are to determine the effect of ATL-104, administered as a swallowable
mouthwash, on a number of parameters associated with chemotherapy induced
mucositis, including mucositis ulceration score, use of opiate analgaesics and
use of parenteral nutrition, as well as safety and tolerability. The
multi-centre trial is to be conducted at several centres in the United Kingdom,
with planned enrolment of 60 patients. Trial results are expected to be
available around the first quarter of 2005.

Commenting, Dr Richard Palmer, Chief Executive Officer said:

"We are very pleased to have received regulatory approval to progress ATL-104
into Phase IIa clinical development for the treatment of mucositis in cancer
patients. This trial seeks to demonstrate proof of concept for this novel
approach to treating the severe and debilitating side-effects of intensive
cancer treatment. The grant of this CTX means that Alizyme now has its fourth
product in, or beyond, Phase II clinical development, emphasising the depth and
maturity of the Company's pipeline."

For further information, please contact:
Dr Richard Palmer, Chief Executive Officer
Tim McCarthy, Finance Director
ALIZYME plc                                                 +44 (0) 1223 896000

Lisa Baderoon/Rebecca Skye Dietrich
BUCHANAN COMMUNICATIONS                                    +44 (0) 20 7466 5000


Further information on Alizyme can be found on the Company's website:
www.alizyme.com

Editors Note


Alizyme plc

Alizyme is a biopharmaceutical company, based in Cambridge, UK, targeting the
treatment and management of gastrointestinal disorders, obesity and diabetes. It
has a portfolio of products which in addition to ATL-104 includes COLAL-PREDTM?
(Phase III approval for the maintenance of remission of ulcerative colitis),
renzapride (completed Phase IIb clinical programme for irritable bowel syndrome)
and ATL-962 (completed Phase IIb trial for obesity). At the appropriate time
Alizyme intends to license products to established pharmaceutical companies,
which will complete development, gain marketing approval and commercialise the
products.

Mucositis

Treatment of cancer with chemotherapy or radiotherapy can result in mucositis in
which the cells lining the mouth and gastrointestinal tract are damaged leading
to inflammation, ulceration, pain, diarrhoea and difficulty in eating and
drinking. Depending on the type of cancer and the treatment administered, it is
estimated that up to 40% of patients receiving cancer therapy suffer mucositis.

There is currently no drug available that can effectively prevent or treat
mucositis. Such a drug would not only improve the quality of life for those
receiving cancer treatment, but also could enable higher therapeutic doses and
more effective treatment. Over one million of the cancer patients treated each
year suffer from mucositis and the potential market for drugs to prevent/treat
mucositis effectively has been estimated at over $1 billion per annum.

Autologous Bone Marrow Transplantation

Autologous bone marrow transplantation involves removal of some bone marrow from
a cancer patient, followed by intensive chemotherapy to destroy their leukaemia
and/or lymphoma, which also results in the destruction of the remaining bone
marrow. The bone marrow is then returned, which regrows. The intensive treatment
to induce bone marrow ablation results in a very high (around 90%) proportion of
patients experiencing severe ulceration of the mouth, such that they require
strong pain-killing drugs and sometimes to be fed via a tube, as well as severe
effects on the bowel and increased risk of septicaemia.

ATL-104

ATL-104 is a plant protein, which is manufactured by a recombinant process. It
has been developed by Alizyme following an agreement in 1996 with Rowett
Research Institute, which gave Alizyme ownership of all intellectual property
involving drugs based on plant lectin proteins. A patent covering this has been
granted in the USA and patent applications are proceeding in other countries.

The effectiveness of ATL-104 in preventing and treating mucositis has been
demonstrated in laboratory models. By stimulating the growth of cells that line
the gastrointestinal tract, ATL-104 acts in a similar way to keratinocyte growth
factor ('KGF'). Amgen has reported encouraging Phase II clinical trial results
with KGF for the treatment of mucositis of the mouth. Although ATL-104 is at an
earlier stage of development, if similar benefits are demonstrated in Phase II
clinical trials in patients, ATL-104 should be well differentiated from KGF
since it can be administered orally and is expected to act topically in the
mouth and gut, rather than having to be injected to act systemically.

Clinical Trials Exemption

A CTX ('Clinical Trials Exemption') allows the testing of drug products in
patients in the UK, after submission of an application, containing safety,
manufacturing and clinical data, to the UK Medicines and Healthcare products
Regulatory Agency.

The identification of compounds for successful research, their progress through
development and the obtaining of regulatory approvals or authorisations before
marketing, manufacture and/or distribution of products is not certain or a
formality.


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