STUDY DEMONSTRATES SILIPHOS® HELPS REDUCE
CHEMOTHERAPY-ASSOCIATED LIVER TOXICITY IN CHILDREN WITH LEUKEMIA
Milan, Italy - February 17, 2010 - Results of a new
study recently published in the online edition of Cancer
showed that silybin (also known as silybinin), the major
active constituent of silymarin, can reduce liver
toxicity in children receiving chemotherapy treatment
for acute lymphoblastic leukemia (ALL) when administered
in a more bioavailable
complex.
The randomized, controlled, double-blind study was
conducted in 50 children undergoing a standard
chemotherapy treatment for ALL known to induce hepatic
toxicity (vincristine, MTX, 6-MP). The participants were
randomized to receive either the silybin–phospholipid
complex (Indena's Siliphos®) or a placebo
orally for 28 days. The complex was obtained through the
Phytosome® technology to enhance its
bioavailability. Liver function tests were performed
during the study.
The study investigated liver toxicity by measuring amino
alanine transferase (ALT), aspartate amino transferase
(AST) or total bilirubin (TB) at day 0, day 28 and day
56. At day 56, patients receiving Siliphos®
had a significantly lower AST and TB, and a trend toward
a significantly lower ALT. No differences in side
effects, incidence and severity of toxicities, or
infections were observed between groups.
The study results demonstrate that Siliphos®
may help reduce liver toxicity in children with acute
lymphoblastic leukemia without antagonizing the effects
of the chemotherapy agents used in the treatment.
