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news.Danish biopharmaceutical company Santaris Pharma has received the go ahead from the FDA to commence its US phase I/II study of its investigational drug candidate SPC2996 in chronic lymphocytic leukaemia.
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The phase I/II clinical trial, the European arm of which is already ongoing in Denmark, the UK and France, is a multi-center study of SPC2996 in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) requiring therapy.
The primary objective is to investigate the safety and potential efficacy of SPC2996 in CLL patients and the company plans to enroll a total of 42 patients. The participation of US centers is intended to facilitate the further development of this novel investigational agent.
SPC2996 is the first of a new class of investigational drugs known as RNA antagonists and is designed to reduce the level of Bcl-2 protein within tumor cells by binding and inactivating Bcl-2 messenger RNA, thereby inducing programmed cell death (apoptosis).
Bcl-2 is highly over-expressed in CLL cells and appears to play a role in pathogenesis of the disease, preventing lymphocyte apoptosis and being strongly correlated with poor clinical outcome.
“The FDA approved the SPC2996 dossier as submitted and without questions. To receive IND approval is always pleasing, but to obtain approval for the first IND for a new class of molecule without any regulatory issues or concerns is particularly gratifying,” commented Lene Worsaae Dalby, vice president of clinical development.