BMG Pharma S.r.l., a specialty pharmaceutical company, has announced the European regulatory approval for its GelX product to be used for the prevention of oral mucositis.
This new regulatory approval for GelX is the first for a medical product to be used for both the treatment and prevention of oral mucositis in cancer patients.
The approval is based on clinical data, (conducted under Good Clinical Practice(GCP) principles) from 149 adult and paediatric patients showing unique results with 99.3 percent of patients experiencing prevention or remission of oral mucositis during cancer therapy.
This new approval will allow patients to receive cancer treatment with a significantly reduced chance of developing oral mucositis during that treatment and to reduce the grade of oral mucositis, allowing the opportunity for normal eating and drinking.
Marco Mastrodonato, founder and CEO of BMG Pharma S.r.l. commented, “We achieved a unique milestones by giving the opportunity to cancer patients to prevent Oral Mucositis in both adults and children which will allow them to continue with a complete nutritional program while under cancer treatment. GelX will be available through its partners to over 1.1m patients in the seven major markets, suffering from oral mucositis as a side-effect of cancer and transplants treatment.’’
(Source: BMG Pharma S.r.l.)
Filed Under: Drug Discovery