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.

“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.”

###

About Siliphos®
Siliphos® is a phytosome obtained from the complexation of silybin with soy phospholipids exploiting the Phytosome® technology to improve gastro-intestinal absorption. Silybin is the most abundant and potent constituent of silymarin, a standardized extract of the fruit of milk thistle (Silybum marianum, Family Asteraceae). The antioxidant properties of silymarin are proven to boost the liver resistance to toxic insults. To learn more about Siliphos® and other phytosomes, please check the newly launched www.phytosomes.info

About Indena
Indena is the world's leading company dedicated to the identification, development and production of active principles derived from plants, for use in the pharmaceutical, health food and cosmetics industries. Backed up by over 85 years of botanical experience, the key to Indena’s success is its intense research activity. The company has more than 150 primary patents and has published more than 700 scientific studies. Indena employs more than 700 staff, including 10% dedicated to full-time research activities carried out at Settala Research Center, near Milan. Indena also co-operates with the world's most prestigious universities and private research institutions. Headquartered in Milan, Indena has 5 production sites and 4 international branches throughout the world and manages distribution operations in more than 40 countries. The Company's experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMEA, and ESCOP, and work with all the main pharmacopoeias.

###
Further Information on Indena: www.indena.com
Further Information on Siliphos® and Phytosome®: www.phytosomes.info