New Clinical Trial

18 November 2013

New clinical trial

Silence Therapeutics plc ("Silence" or the "Company"), a leading RNA interference (RNAi) company, provides the following update.

A second study for Atu027 is planned via an investigator-led study with the University of Birmingham. This study will test Atu027 in combination with cisplatin, 5-FU and cetuximab, concentrating on first line and second line patients with recurrent or metastatic head and neck squamous cell carcinoma

Silence announces that the University of Birmingham plans to carry out a Phase Ib trial to test the safety of Atu027 in combination with cisplatin, 5-FU, and cetuximab. This is the second study in which safety is tested for Atu027 in combination with other cancer treatments. These studies, if positive, would support future investigations on whether Atu027's presumed anti-metastatic activity would work synergistically with the anti-neoplastic activity of traditional oncology drugs.

This Phase Ib study is an investigator-led trial, run by the Institute of Head and Neck Studies and Education at the University of Birmingham, who expect to file for approval to start human studies in the UK early next year, with the Medicines and Healthcare Products Regulatory Agency (MHRA). Standard background treatment in the trial will be funded by the National Health Service. The trial is in the process of being adopted on to the National Cancer Research Institute's head neck portfolio.

Prof. Hisham Mehanna, Director of the Institute of Head and Neck Studies and Education, at the University of Birmingham, and Chief Investigator of the trial commented: "We are very excited about this opportunity to test whether the use of a novel anti-metastatic drug such as Atu027, on top of a combination of cytotoxic agents, may help delay disease progression through development of new metastases in head and neck squamous cell carcinoma (HNSCC) patients. In the next 9-12 months, we are going to recruit up to 18 patients with the aim of evaluating the safety and toxicity of Atu027 in combination of cisplatin, 5-FU and cetuximab, in order to establish a safe dose, as well as to define any dose limiting toxicities, a maximum tolerated dose and recommended dose for a Phase II trial. Additionally, we will seek to develop assays to measure effects of Atu027 on PKN3 and other markers in endothelial cells."

Michael Khan, Chief Medical Officer of Silence also commented: "We are delighted to cooperate with the University of Birmingham on the Phase Ib trial of Atu027 led by Prof. Hisham Mehanna, Chair of the UK's National Cancer Research Institute head and neck group and the Chair of the Research Committee of the British Association of Head Neck Oncologists. Prof. Mehanna is an ideal partner for the trial owing to his proven scientific and clinical capabilities in head and neck cancer, a condition where Atu027's anti-metastatic activity may be of particular significance for patients. "

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