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BTG initiates Phase I trial of AQ4N, an innovative cancer drug

BTG : 11 October, 2006  (Company News)
BTG, a global leader in commercialising innovative technologies, announced today the start of a Phase I clinical study to test AQ4N, a new drug designed to increase the effectiveness of several widely-used anticancer drugs as well as radiotherapy.
This clinical study, funded by BTG and organised by the UK's Cancer Research Campaign, will take place at Leicester Royal Infirmary and Imperial Cancer Research Fund's unit at the Churchill Hospital, Oxford, UK. Consistent with its business strategy, BTG is also seeking a licensee to further develop and commercialise this compound.

The study should provide a good foundation for further trials of the efficacy of AQ4N in a range of tumour types when given with radiotherapy or with cancer chemotherapeutics. The main objectives of the trial are: to establish the maximum tolerated dose of AQ4N either given alone intravenously or in combination with radiotherapy; to determine the toxicity profile of AQ4N and identify the dose limiting toxicity; and to establish a safe dose for Phase II evaluation. Additional Phase I studies are under consideration.

One of the main reasons for failure to cure some cancers appears to be oxygen deficiency, or hypoxia. This is thought to occur in most solid tumours. Hypoxic cells, which may contribute up to 20 percent of tumour mass, are relatively resistant to several established anticancer drugs as well as radiotherapy. These hypoxic cells form a residue within solid tumours from which malignant growth can occur, following re-oxygenation after therapy.

AQ4N is the lead compound selected from a series of hypoxic-cell cytotoxins developed by Professor Laurence Patterson initially whilst at De Montfort University and more recently at The School of Pharmacy, University of London. This drug is designed to be relatively non-toxic until selectively activated within hypoxic cells of solid tumours by enzyme-mediated reduction. It then kills preferentially reservoirs of poorly treated hypoxic cells and immediately adjacent cells. The technology has great potential when used in combination with other treatments, which primarily kill oxygenated tumour cells.

Professor Will Steward, Professor of Oncology at the University of Leicester and principal investigator at the Leicester Royal Infirmary, said: 'We are extremely pleased to be able to give AQ4N to patients and begin to examine its potential benefit. The treatment of hypoxic tumours is a clinical challenge and I am optimistic this drug can overcome the inability of standard chemotherapy and radiotherapy to address this issue.'

Dr Geoffrey Porges, BTG's Executive Vice President and Director, Health, Medical & BioTechnologies, said: 'This is an important milestone in the development of this new anti-cancer drug. It is also a good example of how BTG selectively invests in individual early-stage technologies with the aim of increasing considerably their value.'
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