Positive Pharmacological and Clinical Data for Chemoprevention on Bilberry Extract

Following a study in preclinical carcinogenesis model suggesting that Mirtoselect may prevent malignancies in the gastrointestinal tract, the first-in-human pilot clinical trial has been presented at the Congress.

3 Dec 2009 --- Pharmacological and clinical data for colorectal carcinoma chemoprevention on Indena’s standardized bilberry extract Mirtoselect were presented by Professor Andreas Gescher from the University of Leicester (UK) at the 51st Annual Meeting of the Italian Cancer Society (SIC) in Sesto San Giovanni, Milano (November 23rd-24th, 2009) during the session of “Dietary Supplements and Nutraceuticals in the Management of Cancer”.

Following a study in preclinical carcinogenesis model suggesting that Mirtoselect may prevent malignancies in the gastrointestinal tract, the first-in-human pilot clinical trial has been presented at the Congress. 25 patients with colorectal cancer (and scheduled to undergo resection of primary tumor or liver metastasis) received Mirtoselect 1.4, 2.8 and 5.6 grams daily for 7 days before surgery. Anthocyanins and metabolites were measured in plasma and colorectal tissue. Mirtoselect reduced tumor proliferation in colorectal tumor samples taken from all patients who received the product by 7% compared with pre-intervention values.

“We are pleased that professor Gescher decided to use our product for his research as result of its high level of standardization, chemical characterization and safety profile. These data, even if preliminary, showed that anthocyanins rich bilberry extract may induce beneficial pharmacodynamic changes to counter tumor development in patients” said Antonella Riva, Senior Research Scientist at Indena.

Results from 2 other studies with Indena’s extracts in oncology presented at SIC Congress confirmed the company’s active involvement in oncological research. Indena researchers in conjunction with major Italian research institutes, presented two new posters illustrating important aspects of the pre-clinical work on the novel antitumoral molecules from Brassicaceae sp and Macleaya sp. In particular, during the session of “novel therapeutics approaches”, a poster presented by the Mario Negri Institute in Milan suggested that the isothiocyanate produced from glucomoringin has significant antitumoral activity in myeloma models  in vitro and in vivo. In another poster, presented by the Catholic University of the Sacred Heart, Rome, the alkaloid sanguinarine showed interesting antitumoral activity in mouse models of malignant melanoma. Those two posters, along with the particular attention the company is devoting to the use of standardized extracts from edible plants in cancer prevention, reflect the company’s active participation in oncological research.