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SR Pharma PLC (SPA.L) Announces Start Of Phase I Trial With Novel RNAi Therapeutic RTP-801i In Age-Related Macular Degeneration (AMD)


2/5/2007 11:09:37 AM

LONDON, February 5 /PRNewswire-FirstCall/ -- SR Pharma plc today announces that Quark Biotech Inc. has started a Phase I clinical trial with RTP-801i, a small interfering RNA (siRNA) therapeutic product licensed from Atugen AG, a subsidiary of SR Pharma plc. RTP-801i is based on Atugen's proprietary siRNA (AtuRNAi) technology and modifies the expression or function of one specific gene target, which is involved in the progression of Age-related Macular Degeneration (AMD). RTP-801i has been licensed to Quark Biotech for the treatment of AMD and other diseases. This Phase I study is being funded by Pfizer Inc., which in-licensed RTP-801i in a deal announced on 26 September 2006 for the treatment of AMD.

AMD is the leading cause of blindness in the developed world affecting about 15 million Americans alone over the age of 50. The target indication for RTP-801i is the neovascular or wet AMD. Wet AMD is the most devastating form of the disease and occurs due to the formation of an abnormal vascular network beneath the retina of the eye. These blood vessels are excessively leaky and lead to an accumulation of fluid and blood beneath and within the retina resulting in a loss of visual acuity.

Iain Ross, Chairman, said: "We are excited about the AMD clinical trial commencing as it marks the first clinical study with one of our AtuRNAi molecules. The advancement of this compound represents another strong validation for SR Pharma's proprietary AtuRNAi (siRNA) technology and triggers a further $1.5 million milestone payment. This follows the initial $2 million milestone received in 2006. The fact that this is only the fourth clinical programme with siRNA therapeutics worldwide confirms SR Pharma's leading position in this young Nobel Prize winning technology."

Dr Klaus Giese, Chief Scientific Officer, said "These developments further demonstrate our ability to design siRNA molecules, based on our own patented siRNA chemistry, which can address specific disease targets. This capability means that we are able to generate new molecules for our own development programmes in the cancer field whilst concurrently offering collaboration partners access to stabilised siRNA molecules for use against other targets and indications."

Notes to Editors

SR Pharma (www.srpharma.com)

SR Pharma plc is a European biopharmaceutical company, listed on AIM. The Company has two operating subsidiaries Atugen AG (www.atugen.com) based in Berlin, Germany and Stanford Rook Ltd based in London, UK.

SR Pharma is a leader in RNAi therapeutics, which is a Nobel Prize winning technology that "silences" genes linked to the onset of disease. The Company has developed novel, chemically modified proprietary siRNA molecules ("AtuRNAi"), which have a number of advantages over conventional siRNA molecules including enhanced stability against nuclease degradation. In addition, the Company has developed a proprietary delivery system ("AtuPLEX"), which increases bioavailability, circulation times and functional intracellular uptake of siRNA molecules.

SR Pharma has sublicensed the AtuRNAi compound RTP-801i to Pfizer through its collaboration partner Quark Biotech Inc. for the treatment of AMD and a number of other indications. As announced above, this compound entered the clinic in early 2007. In addition SR Pharma has licensed a further AtuRNAi compound, PFTi, to Quark Biotech Inc., which should enter clinical trials for acute renal failure in 2007. SR Pharma expects to begin the clinical development of its proprietary AtuRNAi therapeutic molecules for systemic cancer indications in 2007.

SR Pharma also owns a proprietary Mycobacterium vaccae-based technology and related products. Currently the Company is in discussions with third parties regarding the co-development and out-licensing of these products.

Forward-Looking Statements

This press release includes forward-looking statements that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. All forward-­looking statements are based on information currently available to SR Pharma and SR Pharma assumes no obligation to update any such forward-looking statements.

SR Pharma plc

CONTACT: For further information, please contact the following: SR Pharmaplc, +44-(0)20-7307-1620, Iain Ross, Chairman, Melvyn Davies, FinanceDirector; Citigate Dewe Rogerson, +44-(0)20-7638-9571, David Dible, ValerieAuffray, Yvonne Alexander; Atugen AG, +49-(0)30-9489-2800, ThomasChristely, Chief Executive Officer, Dr. Klaus Giese, Chief ScientificOfficer


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