Tuesday, April 10, 2012

Delcath Systems, Inc. (DCTH) Secures Training and Launch Agreement for Liver Cancer Treatment Technology with Key Netherlands Cancer Institute

Today, Delcath Systems, the oncology space operator who, as an advanced developer of specialty pharmaceutical and medical devices, has created a bold technological answer to solving metastatic liver cancer via an approach that utilizes isolation/chemosaturation of the liver, reported entry into a key training agreement with the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NKI-AVL) in Amsterdam, supporting launch of the company’s Hepatic Chemosat Delivery System.

Delcath has engineered an ingenious, minimally invasive, repeatable, and high-value method for delivering maximized dosages of chemotherapy directly to the liver, as well as filtering the blood in order to delimit systemic toxicity. This powerful technique has the ability to complement existing treatments, yielding an overall treatment envelope that promises true hope to sufferers from life-threatening liver metastases.

Estimates by the American Cancer Society for primary liver cancer and intrahepatic bile duct cancer for 2012 in the U.S. alone are staggering, with some 28.7k new cases (74% of which are men) being diagnosed at a 71.6% casualty rate. DCTH’s focus on treating primary and metastatic liver cancers is therefore a much welcomed initiative, as the incident rate has nearly doubled in the last decade alone.

Under terms of the agreement DCTH will support the NKI-AVL with logistical/clinical training requirements to cover chemosaturation therapy using the company’s (recently CE Marked, allowing European marketing to commence, with ongoing preparations for FDA approval via an NDA submission) Hepatic CHEMOSAT (chemosaturation system with melphalan) delivery system. This agreement will make the NKI-AVL training site the first location in The Netherlands to offer this ground-breaking treatment, after training has commenced this coming May.

The NKI-AVL is almost a century old and today accommodates some 550 scientists and scientific support personnel (with 53 medical specialists, 180 beds, an out-patient clinic handling some 183k patients annually, 5 operating theaters, and 9 irradiation units), all dedicated to advancing fundamental, clinical, and translational cancer research across a broad spectrum, united by a philosophy that brings scientists and clinicians together for maximum effect in the fight against cancer.

Director of Organization and Management for the NKI-AVL, W.H. Van Harten, MD, comm. Med., PhD, characterized the CHEMOSAT as an important new option for liver cancer treatment, pledging to investigate thoroughly the potential of the system in a whole range of tumor types. Sentiments echoed by NKI-AVL colleague and Interventional Radiologist, Warner Prevoo, MD, who said of the CHEMOSAT system that it was a technological evolution tracked closely at the NKI-AVL, ever since the preliminary results came back from Phase 3 trials and emerged via a 2010 American Society of Clinical Oncology report.

Dr. Prevoo was clearly pleased to be among the European vanguard of medical centers embracing this brave new technology, which promises to offer a treatment option to cancer sufferers throughout the EU (some 47k cases, 46k deaths in 2008, with some 12.7M cases and 7.6M deaths worldwide in the same year according to GLOBOCAN estimates).

President and CEO of DCTH, Eamonn P. Hobbs, understands implicitly the significance of this agreement and eagerly anticipated results from the endeavor, as a longstanding and globally respected institution like the NKI-AVL in Amsterdam, charging ahead with the company’s technology, will be a major PR boon in the wider global oncology market. Success in Europe should translate into FDA acceptance probability and the agreement’s opening of a key, seventh European front for DCTH means optimal saturation of core target markets has been achieved.

Seven early launch centers in Europe, strong hand in Amsterdam via the NKI-AVL agreement, and a winning technology offering spell serious momentum for DCTH investors.

For more information on the agreement, or to stay up to date on the latest developments at Delcath Systems, Inc., please visit the company’s website at: www.delcath.com

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