The company’s decision to submit a clinical trial application (CTA) follows a board review of progress with Atu027 and, in particular, consideration of recent discussions with BfArM, the German regulator for drugs and medical devices. Atu027 is a small interfering RNA (siRNA) molecule that is being developed for the systemic treatment of cancer.
Silence anticipates commencing its Phase Ib human clinical study of Atu027 in cancer patients in 2009, provided the relevant approvals are forthcoming. The company also confirmed that it has identified a number of new targets and indication opportunities that it intends to progress in 2009.
Iain Ross, chairman and CEO of Silence Therapeutics, said: The filing of this CTA is a very important milestone for Silence. Atu027 is a systemically delivered siRNA product, which has data to support repeated dose administrations over a 28-day period. Moving to human clinical testing in 2009 will be a significant step forward.
I am also pleased to confirm that by managing our cash reserves prudently the
company will have sufficient cash to fund its business regardless of whether
the ongoing partnership discussions are concluded in 2008 or in 2009.