Friday, January 11, 2008 7:59:57 AM
Protherics PLC announces Research Update
Friday January 11, 2:00 am ET
Cheshire, UK--(MARKET WIRE)--Jan 11, 2008 --
Protherics PLC
Protherics and Advancell start Acadra(TM) clinical study
in B-cell chronic lymphocytic leukaemia
London, UK; Brentwood, TN, US; 11 January 2008 - 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."
http://biz.yahoo.com/iw/080111/0347391.html
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