CeloNova BioSciences, Inc. (CeloNova), today announced that the U.S. Food and Drug Administration (FDA) has granted approval to start an investigational device exemption (IDE) clinical trial for its novel ONCOZENE™ embolic microspheres, loaded with doxorubicin, a chemotherapy drug used in the treatment of Hepatocellular Carcinoma (HCC). HCC is the most common primary liver cancer and accounts for approximately 600,000 deaths annually on a worldwide basis1. Untreated HCC patients have a median survival time of less than 12 months2.
CeloNova’s ONCOZENE™ microspheres small sizes and precise calibration allow for super selective embolization combined with distal penetration which may greatly increase the chemotherapeutic impact at the tumor site, while lowering the toxicity in other parts of the body, thereby potentially improving the patient’s tolerance of the treatment. CeloNova’s TANDEM™ microspheres are available in Europe and bear the European Union’s CE mark since it was granted in 2012 for embolization of HCC, with or without delivery of doxorubicin.
“Our ONCOZENE™ microspheres platform, when combined with its precise drug delivery capability, presents a potentially improved treatment option for liver cancer patients,” said Jane Ren, Ph.D., CeloNova’s Chief Technology Officer. “We are very pleased to be working with the leading HCC experts in the world to alleviate the pain of our patients.”
“We are excited to move ONCOZENE™ microspheres into a pivotal Phase 3 trial,” said Dr. Ghassan Abou-Alfa at Memorial Sloan-Kettering Cancer Center. “Early studies have shown that Liver-Directed Therapies utilizing drug eluting microspheres such as ONCOZENE™ microspheres provide an excellent treatment option for locally advanced HCC patients.”
“This IDE trial is designed to develop an evidence-based treatment plan for late stage HCC patients and will enroll patients in multiple cancer centers across the United States, Europe and Asia,” said Dr. Riccardo Lencioni, Professor at the Pisa University School of Medicine in Italy and Chairman of the World Conference on Interventional Oncology (WCIO).
CeloNova CEO Martin Landon commented, “The recent expanded indication for our ONCOZENE™ and EMBOZENE™ microspheres, to include embolization of Hepatoma, combined with this IDE trial approval for ONCOZENE™ microspheres loaded with doxorubicin, represent two more ´industry first´ examples of how we are executing on our vision to bring unique and disruptive solutions to physicians, patients and payers that improve patient care and add significant clinical and economic value to the healthcare community.”
The company announced on September 3, 2014 that the FDA had issued 510(k) clearance expanding the indication of its ONCOZENE™ and EMBOZENE™ microspheres products to include the treatment of Hepatoma, also known as HCC. That approval provides support for another treatment option for physicians and patients in their battle against primary liver cancer.
About the Company
CeloNova BioSciences, Inc., headquartered in San Antonio, Texas, is a global medical device company that develops, manufactures and markets a family of Interventional Cardiology and Endovascular products. Our products are developed and manufactured in Carlsbad, California, U.S.A. and Ulm, Germany. The Company’s regional offices are located in Germany, France, United Kingdom, Netherlands and Austria. For additional information about CeloNova BioSciences, see the company website at www.celonova.com.
Forward-looking statements contained in this press release are based on estimates and assumptions of CeloNova management and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made. We do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied based on a number of factors, including but not limited to, unexpected clinical trial timing and outcomes, results of expanded clinical experience and unanticipated impacts of regulatory decisions
References:
1. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics. CA Cancer J Clin. 2005;55:74-108.
2. Greten TF, Papendorf F, Bleck JS, Kirchhoff T, Wohlberedt, Kubicka S, Klempnauer J, Galanski M, Manns MP. Survival rate in patients with hepatocellular carcinoma. Br J Cancer May 23, 2005; 92(10):1862-1868
