Atu027 update: progression into Phase IIa

Atu027 update: progression into Phase IIa

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

Progressing the Phase Ib/IIa study (Atu027-I-02/ NCT01808638) of the RNAi therapeutic Atu027 in combination with gemcitabine to the main part of the study after completion of lead-in safety period.

Silence announces that the Data Safety Monitoring Board (DSMB) has unanimously recommended the continuation of the Phase Ib/IIa study of Atu027. The Phase Ib/IIa study uses Atu027 in combination with gemcitabine, a chemotherapy agent in patients with advanced pancreatic cancer qualifying for first-line-treatment. The recommendation was made after the DSMB reviewed results from the completed safety lead-in period in patients with refractory cancer disease supporting the tolerability of this combination. The timing of this recommendation is consistent with our expectations as disclosed in the 5 March 2013 business update. 

Silence will start recruiting patients with loco-regionally advanced or metastatic pancreatic cancer, the main part of the Phase Ib/IIa study.  In this disease, the tumor micro-environment is implicated in fostering tumor growth, invasion and metastasis. The investigational drug combination aims to attenuate further disease progression by combining the anti-neoplastic activity of gemcitabine with the anti-metastatic action of Atu027. We continue to expect to recruit all patients by mid-2014, and complete one-year follow-up on them by mid-2015. Further indications for Atu027 as well as non-oncology opportunities for other drug candidates are being evaluated and will be disclosed in due course.

Prof. Dr. med. Joachim Drevs, the chair of the DSMB commented: "This safety lead-in part of the trial is the first clinical safety experience of combination use of Atu027 (with its presumed anti-metastatic activity via knock down of PKN3 in the host endothelium) with a chemotherapy agent that acts directly on the primary tumour. The study protocol calls for the safety cohort to expand from three to six if any of the three subjects experiences an unacceptable toxicity; we did not find this necessary. We look forward to seeing Atu027 progress in the main part of the study."

Additional information about this trial can be found at www.clinicaltrials.gov.

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