CHEMOSAT®, marketed by medac Pharma, is a minimally invasive delivery system for the administration of high-dose chemotherapy directly to the liver while controlling systemic exposure. CHEMOSAT® is used predominantly to treat patients with unresectable liver-dominant metastatic ocular melanoma.
Delcath Systems, Inc. (the manufacturers of CHEMOSAT®) will present new preliminary data from the Phase 3 FOCUS trial at the Annual ASCO Meeting next week.
“Percutaneous hepatic perfusion (PHP) with melphalan for patients with ocular melanoma liver metastases: Preliminary results of FOCUS (PHP-OCM-301/301A) phase III trial” presented by Jonathan S. Zager, MD FACS is taking place on June 4, 9:00 AM (EDT) (2:00 PM in the UK).
Dr Zager will be presenting on behalf of the Principal Investigators that participated in the FOCUS trial.
FOCUS is an open label, single-arm, multi-centre trial, conducted in 23 centres in USA and EU sponsored by Delcath Systems, Inc. The trial is intended to evaluate the efficacy, safety and pharmacokinetics of melphalan hydrochloride in combination with CHEMOSAT® in patients with hepatic-dominant ocular melanoma. In the oral presentation at the ASCO Annual Meeting we are expecting new positive data regarding the prespecified endpoints overall response rate, median progression free survival and disease control rate.
CHEMOSAT® is a device used in Chemosaturation therapy, an innovative technique developed to treat metastatic liver cancer that has been shown to be particularly effective for metastases that have occurred from ocular melanoma.
During the procedure, the blood flow from the liver to the rest of the body is diverted (hepatic vein isolation) before the chemotherapy drug melphalan is delivered directly into the liver (percutaneous hepatic artery perfusion), potentially targeting both visible tumours and undetected microtumours. Blood leaving the liver is then taken out of the body and through the specialist CHEMOSAT® filter which removes the melphalan before the blood is returned to the body. The aim is to allow high doses of melphalan chemotherapy to be used, which would otherwise not be tolerated because of severe systemic side effects.
About medac Pharma
medac Pharma is a privately owned, pharmaceutical company specialising in product development and the treatment of diseases within the key areas of oncology, autoimmune and urology.
medac GmbH was originally founded in Germany in 1970 and the UK operation was established in 1993. Since then we have become known for developing innovative products, especially in less common indications, which have resulted in a comprehensive portfolio of pharmaceutical products which help make a positive difference to the lives of your patients. We are committed to supplying therapeutic products and providing the diagnostic resources to identify diseases. We continue to invest in our manufacturing and logistic capabilities to ensure we meet the increasing demand of both healthcare professionals and patients’ needs.
ABOUT DELCATH SYSTEMS
Delcath Systems Inc is an interventional oncology company focused on the treatment of primary and metastatic liver cancers and are the manufacturers of CHEMOSAT®. Their US headquarters are in New York with its European headquarters based in Galway in the Republic of Ireland.
For further information, please visit www.chemosaturationphp.co.uk