Santaris Pharma initiates Phase I/II multi-centre clinical trial in Chronic Lymphocytic Leukaemia

First of a new class of LNA-based anti-cancer drugs to enter the clinic

Copenhagen, 19th May 2005: Santaris Pharma, the Danish biopharmaceutical company developing gene-targeting drugs for the treatment of cancer, today announced that, having recently received regulatory approval, it is initiating a multi-centre, international Phase I/II study of SPC2996 in the treatment of Chronic Lymphocytic Leukaemia (CLL).

SPC2996 is the first of a new class of LNA-based anti-cancer drugs known as RNA Antagonists and is designed to reduce the level of Bcl-2 protein within tumour cells by binding and inactivating Bcl-2 messenger RNA, thereby inducing programmed cell death (apoptosis). Bcl-2 is highly over-expressed in CLL cells and appears to play a role in pathogenesis of the disease, preventing lymphocyte apoptosis and being strongly correlated with poor clinical outcome.

The Phase I/II trial is an escalating, repeated dose study of this new investigational drug in CLL patients who have failed or no longer respond to chemotherapy. The trial will evaluate the safety and efficacy of SPC2996 in CLL and will be an open label, international, multi-centre study taking place in nine leading European centres for the treatment of haematological cancers in Denmark, UK and France.

Keith McCullagh, President and CEO of Santaris Pharma commented: “This is our first product to enter the clinic and the first human study world-wide of a drug from this new class of LNA-based RNA Antagonists. Santaris is pioneering this new approach to cancer therapeutics.”

Lene W. Dalby, M.D., Santaris Pharma’s Vice President of Clinical Development, commented: “We are pleased to announce the initiation of clinical studies with SPC2996, our lead drug candidate. CLL is a disease with significant unmet medical needs and by acting via a new mechanism, SPC2996 may improve outcomes in patients with progressing CLL”.

Professor Bertrand Coiffier, of the Hospices Civils de Lyon, the study’s International Coordinating Investigator, said: “Improvements in the treatment of Chronic Lymphocytic Leukaemia are still much needed and we are enthusiastic to be involved in the initial clinical evaluation of this novel anti-Bcl-2 drug.”

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For further information, contact:

At Santaris

Keith McCullagh, President & CEO
Tel. +45 4517 9819
km@santaris.com

Lene W. Dalby, Vice President, Clinical Development.
Tel. +45 4517 9870
lwd@santaris.com

At Northbank Communications

Douglas Pretsell
Tel: +44 20 7886 8158
d.pretsell@northbankcommunications.com

Sue Charles
Tel: +44 20 7886 8152
s.charles@northbankcommunications.com

NOTES FOR EDITORS

About Santaris Pharma:

Santaris Pharma A/S is a clinical-stage biopharmaceutical company focussed on developing innovative new drugs for the treatment of cancer. Created in May 2003, Santaris Pharma is backed by a broad group of Scandinavian life-science venture capital investors.

The Company’s drug pipeline is comprised of novel RNA antagonising drugs based on unique proprietary Locked Nucleic Acid (LNA) chemistry. LNA drugs, with their high potency and biostability, have the potential to transform the field of gene-targeted therapeutics, making specific and effective gene silencing a reality in human medicine. If this potential is realised, even in part, it should be possible to design new drugs to treat a wide variety of human diseases by switching off the expression of harmful genes. Santaris Pharma holds the world wide patent rights to the exploitation of LNA in pharmaceuticals.

With the initiation of clinical studies, Santaris Pharma is currently raising new equity funds to finance the continued clinical development of SPC2996 and its other RNA Antagonist drugs in development. The Company plans to raise approximately 20m Euro of new equity in 2005, approximately 50% of which is expected to come from exiasting shareholders and 50% is targeted from new investors.

For further information see www.santaris.com

About Chronic Lymphocytic Leukaemia:

Chronic Lymphocytic Leukaemia (CLL) is a cancer of the blood characterized by a progressive accumulation of long-lived, functionally incompetent lymphocytes. CLL is the second most common type of leukaemia and 8,000 new cases are diagnosed each year in the US alone. The condition mostly affects people over 50 years of age and there is currently no cure, although progression of the cancer can often be delayed by current therapeutic regimens.

About SPC2996:

SPC2996 is an investigational new chemical entity and the first of a new class of drug known as RNA Antagonists. The drug is composed of a short single chain of nucleotides including LNA, a conformational analogue of RNA, which confers very high specific RNA binding activity on the drug. SPC2996 acts by inhibiting the synthesis of Bcl-2, a key sensor protein that protects cells against apoptosis (programmed cell death). The protein is expressed in most cancers including CLL and high expression levels correlate strongly with low response rates and resistance to chemotherapy, faster time to relapse and shorter survival time. Down-regulation of Blc-2 expression thus provides an attractive means by which CLL and many other cancers can be re-sensitised to natural apoptotic stimuli and to chemotherapeutic agents that provoke apoptosis.