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Silence Cleared to Test Cancer Drug in Pancreatic Cancer

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Silence Therapeutics said this week that it has received clearance from German regulators to start a phase Ib/IIa clinical trial of its lead cancer drug Atu027 in combination with the widely prescribed chemotherapeutic gemcitabine for pancreatic cancer.

The company said that the first portion of the study will take approximately three months to complete, and the phase IIa portion about a year. The entire trial is expected to wrap up in mid-2014.

Silence also said that the regulators suggested that the drug combination be tested in a “wide range of cancers, and that such trials could be run in parallel with the pancreatic cancer study.

Atu027, which comprises blunt-ended siRNAs targeting the protein kinase PKN-3, recently finished a phase I dose-finding trial in patients with advanced or metastatic solid tumors.

In June, Silence said that preliminary data from the study indicate that 0.336 mg/kg is the maximum tolerated dose of the drug, and that treatment at 0.18 mg/kg achieved the same blood plasma siRNA concentration that in preclinical studies triggered PKN3 silencing.

Silence also said this week that it is “actively looking for an aggressive expansion” of its technology platform, which includes a stable of drug-delivery approaches, drug targets, and key personnel.

“The company and its major shareholders are reviewing the financing options in respect of this expansion,” Silence said, noting that it has roughly £8 million ($12 million) on hand.

Company officials did not return a request for additional comment.

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