Study Demonstrates Siliphos Helps Reduce Chemotherapy-Associated Liver Toxicity in Children with Leukemia

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.

18 Feb 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.

“Indena is excited about the positive results of Siliphos on chemotherapy-associated liver toxicity in children with leukemia” - said Antonella Riva, Senior Research Scientist at Indena – “Siliphos has been extensively used and investigated for maintaining healthy liver function, and these preliminary results indicate another potential benefit for Siliphos to preserve liver function, even under severe hepatotoxic challenge.”