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Modern Biosciences plc - Initiates Phase I clinical trial in cancer

16 Apr 2008

Modern Biosciences plc (“MBS”), the drug development company, is pleased to announce that it has initiated dosing for a Phase Ia clinical trial of rimcazole, a novel anti-cancer agent.

Rimcazole, a sigma receptor ligand, has shown significant activity in pre-clinical models of cancer, including breast, lung and prostate cancers. Exclusive worldwide rights to develop and market rimcazole for the treatment of cancer were licensed to MBS by the University of Dundee in August 2007.

The Phase Ia trial will include 12 healthy volunteers and will examine safety and pharmacokinetics. Results are expected in the second half of 2008. A Phase Ib trial designed to yield proof-of-principle data is expected to start in early 2009.

Dr Sam Williams, Chief Executive Officer of Modern Biosciences, said: "The fact that we have moved rimcazole into the clinic just eight months after licensing the programme from the University of Dundee is evidence of MBS’ ability to identify viable drug development programmes from UK academia and to advance these towards proof-of-principle studies in a timely and cost-effective manner. We and the University of Dundee look forward to the results from the current Phase Ia trial later this year and the initiation of Phase Ib.”

For further information, please contact:

Modern Biosciences 
Dr Sam Williams 020 7002 1529

Press Enquiries for Modern Biosciences 020 7357 9477
The Hogarth Partnership 
Melanie Toyne-Sewell / Sarah MacLeod / Simon Hockridge

Notes for Editors

About rimcazole

Rimcazole represents a highly attractive development candidate as it has already been the subject of a clinical trial programme in a different therapeutic area, schizophrenia. The re-profiling of rimcazole for cancer is lower risk than a normal development programme as there is already a considerable amount of pre-clinical and clinical safety data available for the drug.

Rimcazole has several features that make it particularly promising for the treatment of cancer:

it is a small molecule drug that can be taken orally;
it works via a dual mechanism of action that makes it highly potent – stimulating apoptosis (cell ‘suicide’) and preventing angiogenesis (the growth of blood vessels) within tumours;
it has activity against a broad range of cancer types;
it has very little toxic effect towards normal, healthy tissues, which means it is likely to have a low side effect profile.

The development of rimcazole for the treatment of cancer has been made possible through the groundbreaking research of Dr Barbara Spruce and her team at the University of Dundee. Dr Spruce’s work has focussed on the so-called ‘sigma-1 receptor’, which has been the subject of considerable pharmaceutical research in the field of psychiatric and neurological disorders.

Dr Spruce and her team were the first to show that agents that bind to the sigma-1 receptor (such as rimcazole) cause tumour cells, but not normal cells, to undergo apoptosis. In recognition of her work, Dr Spruce received the inaugural Gannochy Trust Innovation Award of the Royal Society of Edinburgh in 2003.

About Modern Biosciences

Modern Biosciences is a drug development company which sources late-stage discovery projects from academia and start-up companies, conducts early proof-of-principle clinical studies and out-licenses the resulting programmes to the pharmaceutical and biotechnology industries. The Company has three projects in development; two in the field of cancer and one in inflammation.

For more information, please visit our website at www.modernbiosciences.com

About The University of Dundee

The University of Dundee has powered its way to an internationally recognised position of excellence in life sciences and medical research with particular expertise in cancer, diabetes, cardiovascular and tropical diseases. The University has both a 5* rated School of Medicine and College of Life Sciences, with research expanding from "the cell to the clinic to the community", and has a larger medical research complex than the National Institute for Medical Research in London. The University has an excellent track record in attracting research income and commercialising research activity. See www.dundee.ac.uk for further details.



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