Santaris begins multi-center leukemia trial

The trial is an escalating, repeated dose study of this new investigational drug in chronic lymphocytic leukemia (CLL) patients who have failed or no longer respond to chemotherapy. The open label investigation will evaluate the safety and efficacy of SPC2996 in CLL.

The study will take place in nine leading European centers for the treatment of hematological cancers in Denmark, the UK and France. It is therefore the first worldwide clinical study of a drug from this new class of LNA-based RNA antagonists and signifies Santaris Pharma’s first product to enter a clinical trial.

Lene Dalby, Santaris Pharma’s vice president of clinical development, commented: “We are pleased to announce the initiation of clinical studies with SPC2996, our lead drug candidate. CLL is a disease with significant unmet medical needs and by acting via a new mechanism, SPC2996 may improve outcomes in patients with progressing CLL.”

SPC2996 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.