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Clinical Trials

Date: 2012-02-27

Type of information:

phase:

Announcement: initiation

Company: Apeiron Biologics (Austria)

Product: liposomal topical formulation of the enzyme human recombinant superoxide dismutase (project APN201)

Action mechanism:

Disease: prevention of radiation dermatitis in breast cancer patients.

Therapeutic area: Cancer Oncology

Country: Austria

Trial details: The double blind, placebo-controlled study is conducted at a single center and shall enroll 20 breast cancer patients that receive radiation therapy after breast-preserving surgery. Superoxide dismutase (SOD) is an enzyme that degrades and renders harmless highly reactive oxygen radicals that occur, amongst other situations, during radiotherapy of cancer. This pilot study aims at investigation of safety and tolerability of topical APN201 as well as hints for efficacy to prevent radiation dermatitis in breast cancer patients that undergo radiotherapy after surgery.

Latest news: Apeiron Biologics has announced that a clinical trial has started with the agent superoxide dismutase (project APN201) to investigate its potential for prevention of radiation dermatitis in breast cancer patients.
The clinical trial has started with a liposomal topical formulation of  the enzyme human recombinant superoxide dismutase (project APN201) at the University Hospital for Radiation Therapy / Radio-oncology of the Medical University Graz. The product is being developed clinically in collaboration with the Austrian contract manufacturer Polymun Scientific.

Is general: Yes