News
Protherics and Advancell start Acadra(TM) clinical study in B-cell chronic lymphocytic leukaemia
Protherics PLC ("Protherics" or the "Company"), the international biopharmaceutical company focused on critical care and cancer, and its co-development partner, Advancell s.l. ("Advancell"), today announce that the first patient has now been enrolled in a recently initiated phase 1/2 clinical study of Acadra(TM) (acadesine) in B-cell chronic lymphocytic leukaemia (B-CLL).
Most drugs currently used to treat B-CLL also kill T-cells, suppressing the patient's immune system and increasing the risk of serious infection; a common cause of death in patients with B-CLL. Acadra(TM) is a potentially selective treatment for B-CLL which has been shown to cause the death of B-cells whilst sparing T-cells in blood samples from patients with B-CLL. Acadra(TM) has also shown the capacity to kill B-CLL cells that are resistant to current therapies, such as fludarabine. Protherics and Advancell are jointly developing Acadra(TM) in this indication following a licensing and co-development agreement announced in December 2006.
The phase 1/2 study will be conducted at sites in Belgium, France and Spain and will enroll up to 30 B-CLL patients who have relapsed or are refractory to existing chemotherapy. The open-label study is designed to assess the safety, tolerability, pharmacokinetics and the effects on Acadra(TM) on B-cell and T- cell counts. Part I of the study will investigate escalating single doses of Acadra(TM) following in part II by an assessment of repeated doses. Results from part I of the study are expected in the second half of 2008 and the final study results are expected in the first half of 2009.
Luis Ruiz-Avila, Chief Executive Officer of Advancell, commented:
"We are delighted that Acadra has entered its first clinical study in patients with B-CLL. The current study is designed to demonstrate proof of concept in terms of the selective targeting of B-cells in patients that are resistant or refractory to fludarabine."
Andrew Heath, Chief Executive of Protherics, commented:
"Acadra is an exciting new therapy being developed to improve the safety and tolerability of chemotherapy in B-CLL patients. We expect to get an early indication of selectivity in this open-label study and we are encouraged by the strong ex-vivo data generated to date."