RNA Antagonist SPC2996 Receives FDA Approval For Phase I/II Trials

Filed in archive Drugs, Vaccines and Therapeutics on November 8, 2005

Santaris Pharma, a Danish biopharmaceutical company developing anti-caner drugs using RNA-interference technology, received US FDA approval for its international Phase I/II study of SPC2996, an Investigational New Drug (IND) against Chronic Lymphocytic Leukaemia (CLL).

CLL is a type of blood cancer resulting from accumulation of long-lived, but non-functional lymphocytes. Over time, these abnormal cells cause complications as it replace the normal white cells, red cells and platelets in the bone marrow.

SPC2996 is the first of a new class of RNA-based investigational drugs known as RNA Antagonists. By binding to and inactivating Bcl-2 messenger RNA, SPC2996 reduces the level of Bcl-2 protein in tumor cells. Bcl-2 is a key intracellular protein that protects cells against apoptosis (programmed cell death). By down-regulating the production of Bcl-2 proteins, aging lymphocytes proceed to natural cell death.

Phase I/II clinical trials are already ongoing in Denmark, UK and France.
The first US center to join the study will be the Holden Comprehensive Cancer Center at the University of Iowa.

More info from Bioportfolio.