Antisoma plc -- R&D Update: AS1404 Advancing to Phase II Trials; AS1405 Starts Clinical Trials in Brain Cancer


LONDON, March 22, 2004 (PRIMEZONE) -- Antisoma plc (LSE:ASM), the biopharmaceutical company specialising in the development of novel anti-cancer drugs, will today hold an R&D update for analysts and investors. This will focus on a number of the Company's earlier stage clinical and preclinical products.

Announced today

Two of the drugs covered in today's update are the subject of significant progress announcements. AS1404 (DMXAA) has completed phase I studies and will now move into phase II, while AS1405 (formerly AngioMab) has begun its first phase I clinical trial. Though their actions are different, both drugs attack cancer by targeting tumour blood vessels.

AS1404

The third and final phase I study of AS1404 as a monotherapy has been successfully completed. This has provided data required to plan a phase II programme of combination studies, which is scheduled to start during the second half of 2004. AS1404 is considered most likely to provide a benefit when used alongside other therapies. Separate trials will be conducted in different tumour types, each combining AS1404 with an established cancer treatment. In at least one of the trials AS1404 will be given with taxane drugs because this combination has shown particular promise in preclinical work. AS1404 belongs to a class of drugs called 'vascular targeting agents' which specifically disrupt tumour blood vessels. The drug therefore has potential against a wide variety of cancers.

AS1405

AS1405 has started its first trial in patients with a highly malignant brain cancer called glioma. The phase I trial will provide information on safety, dosing and distribution of the drug, as well as looking for any initial signs of anti-tumour activity. Patients included in the study have suffered a relapse of their glioma with regrowth of the tumour after their initial treatment. The majority of the new tumour growth will be removed by surgery followed by an injection of AS1405 into the cavity left in the brain. AS1405 is a radiolabelled antibody that binds to a protein found around new tumour blood vessels. It delivers a targeted dose of radiation with the aim of preventing or delaying the relapse of cancer.

Because glioma is a relatively rare cancer, a so-called 'niche indication', AS1405 is not included in Antisoma's alliance with Roche. Antisoma intends to pursue alternative routes to commercialisation, with the intention to maximise its retained share of the product's value. Given the very poor results with current treatments, Antisoma considers this an attractive opportunity. The Company estimates that on the basis of the need for a suitable surgical history, and taking together newly diagnosed patients and those with recurrent disease, some 29,000 patients could be eligible for the treatment each year in North America, Europe and Japan.

R&D update overview

Three external experts will speak on the background to Antisoma's AS1404, AS1405 and telomerase inhibitor programmes.

The background to vascular targeting agents, the class of drugs to which AS1404 belongs, will be provided by Prof Richard Begent of the Royal Free and University College Medical School, UCL. He will consider the variety of ways to attack tumour blood vessels and how drugs of this type can be combined with other cancer treatments to maximise their effect.

Prof David Thomas, a neurosurgeon from The National Hospital for Neurology and Neurosurgery in London, will talk about the issues in treating brain cancers. Speaking in advance of the meeting, Prof Thomas said: "Brain cancer is a huge challenge; we can often operate to remove the bulk of the cancer, but we need drugs that can be used alongside surgery to attack the cancer that we can't get out. There's a lot of interest at the moment in targeted approaches such as the use of monoclonal antibodies."

Professor Stephen Neidle of the London School of Pharmacy will describe the anti-cancer drugs known as telomerase inhibitors. He developed the programme of telomerase inhibitors that Antisoma in-licensed from Cancer Research UK during 2003.

In addition to the external speakers, Dr Nigel Courtenay Luck, Chief Scientific Officer of Antsioma, will highlight the broad potential of antibodies in cancer treatment, illustrated by the ways in which Antisoma is adapting its antibodies for use in different settings. These include development of naked antibody drugs like R1550, radiolabelling approaches as used in R1549 and AS1405, linking of apoptosis enzymes as in AS1406, and most recently the use of antibodies in conjunction with cytokines, illustrated by the ATTACK programme under co-development with EMD Lexigen Research Center of the US.

Speaking before the R&D update, Glyn Edwards, Antisoma's Chief Executive Officer commented: "The advances we have announced today for AS1404 and AS1405 show the steady progress we are making in developing and broadening our clinical pipeline. Today's event will also highlight the strong scientific foundations on which our programmes and collaborations are based."

About Antisoma

Based in London, UK, Antisoma is a biopharmaceutical company that develops novel products for the treatment of cancer. The Company fills its development pipeline by acquiring promising new product candidates from internationally recognised academic or cancer research institutions. Its core activity is the preclinical and clinical development of these drug candidates. Antisoma forms partnerships with pharmaceutical companies to bring its products to market. In November 2002, Antisoma formed a broad strategic alliance with Roche to develop and commercialise products from Antisoma's pipeline. Please visit www.antisoma.com for further information about Antisoma.



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