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Pharmacokinetics of Natural Berry Extracts as a Treatment for Hemangiomas

Gayle Gordillo, Abhishek Sen, Amitava Das
Indiana University School of Medicine, Division of Plastic Surgery
2020-02-19

Presenter: Abhishek Sen

Affidavit:
The work presented by scholar Abhishek Sen is original.

Director Name: Gayle M Gordillo

Author Category: Other Specialty Resident
Presentation Category: Basic Science Research
Abstract Category: General Reconstruction

Purpose: Current therapies for infantile hemangiomas (IH) have high risk side effect profiles. A proprietary blend of natural berry extracts (NBE) is being developed as a safer alternative treatment. Efficacy was evaluated when NBE was applied topically and administered orally as well as comparison with oral propranolol using a validated mouse model of hemangioma.
Methods: Two doses of NBE - low (1.5% anthocyanin) and high (8% anthocyanin) - were used to treat hemangioendothelioma tumors in 129P3 mice. Topical application (200mg/kg) and oral gavage (20mg/kg) routes of administration were studied individually and in combination. Results using propranolol treatment (human equivalent dosage of 3mg/kg/daily) was conducted to compare efficacy of treatment.
Results: Topical application of the low NBE dose decreased tumor volume by 40% at day 7 and significantly prolonged survival. When the same treatment was complemented with oral gavage, tumor volume was observed to reduce over 50% while doubling survival days. High dose topical + oral NBE treatment was equally effective at shrinking tumors and had a longer median survival time compared with propranolol. NBE absorption was identified in tumors and plasma with peak anthocyanin concentration in plasma in 5 min after topical treatment with a half-life of 7.7 hours.
Conclusions: Using a validated murine model of IH, we achieved a significant reduction in tumor size and increased survival following NBE treatment. This is the first report of kinetics for a nutraceutical agent when applied topically. This will enable the development of dosing strategies in preparation for clinical trials.

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