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Silence Therapeutics to Present New Data from Phase I Study with Atu027 at 2011 ASCO Annual Meeting

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Silence Therapeutics plc has announced that it will present new data from its ongoing Phase I study of Atu027, its lead internal therapeutic candidate, at the 2011 American Society of Clinical Oncology (“ASCO”) Annual Meeting on 06 June 2011.

Top-line data includes results for 21 patients who received the study’s first seven escalating doses of Atu027 and show that six of these patients experienced stable disease after three months.

One patient with neuroendocrine cancer had disease stabilization for nine months, a second neuroendocrince cancer patient experienced partial regression of pulmonary metastases, and a patient with breast cancer demonstrated regression of liver metastases.

More data from the ongoing Phase I Atu027 clinical study will be the subject of a poster presentation at ASCO with the following details:

Abstract Title: First-in-human phase I study of Atu027, a liposomal small interfering RNA formulation, targeting protein kinase N3 (PKN3) in patients with advanced solid tumors

Abstract #: 3057

Poster Session: General Poster Session: Developmental Therapeutics - Experimental Therapeutics

Presentation Date/Time:    Mon, June 06, 2011 / 8:00am - 12:00pm

Location: Hall A - Poster Board #13F

Presenters: Klaus Giese, Ph.D., chief scientific officer of Silence, and Dr. Dirk Strumberg, Professor of Medicine and Director, Department of Hematology and Medical Oncology, University of Bochum, Marienhospital Herne, the study’s principal investigator

Silence’s open label, single-centre, dose-finding Phase I study of Atu027 in subjects with advanced solid cancer is ongoing with dose escalation continuing. The study is designed to evaluate a total of 11 escalating doses of Atu027 and enroll approximately 33 patients.

Across the first seven completed dose levels, Atu027 was generally well tolerated with no dose-limiting toxicities observed. Additionally, as consistent with preclinical data, preliminary Phase I pharmacokinetic (PK) data showed dose-dependent increase in plasma siRNA and lipid levels, suggesting no evidence of drug accumulation during repeat treatment.

Silence expects to complete the ongoing Phase I clinical trial of Atu027, one of the most clinically advanced RNAi therapeutics in the area of oncology, in the second half of 2011. The full ASCO abstract for the Phase I Atu027 study is now available online at: http://chicago2011.asco.org/.

“This positive data to date is very encouraging and we believe the disease stabilization and antitumor activity, in particular, are suggestive of a potential therapeutic benefit for extremely ill patients who have no other treatment options,” said Philip Haworth, Ph.D., chief executive officer of Silence Therapeutics. “This data marks Silence’s continued progress in the area of RNAi therapeutic development, and we look forward to sharing more complete findings from the ongoing Phase I study at ASCO in June.”