FeRx Receives Approval From China's State Drug Administration To Conduct Phase II Clinical Trial Of MTC-DOX In Primary Liver Cancer
Study Marks First Time An Investigative Therapy Has Been Approved For Clinical Trials in China Prior to Regulatory Approval in the West
SAN DIEGO ¨C May 22, 2001 ¨C FeRx Incorporated today announced that it has received approval from the State Drug Administration (SDA) in Beijing, People¡¯s Republic of China, to conduct a multi-center Phase II clinical study utilizing its proprietary MTC technology to deliver its lead compound, MTC-Doxorubicin (MTC-DOX), in patients with primary liver cancer (hepatocellular carcinoma or HCC). The action marks the first time the SDA, the Chinese equivalent of the U.S. Food and Drug Administration, has approved an investigative procedure that has not first been approved for commercial use in ICH regions (U.S., Europe and Japan). The announcement was made at the UBS Warburg Global Specialty Pharmaceuticals Conference in New York City.
The SDA action also marks the first time a small, U.S.-based, independent biotechnology company, rather than a global pharmaceutical company, has received approval to undertake a multi-center clinical study of a novel therapeutic method in China, conducted under the new national GCP (Good Clinical Practice) guidelines enacted in May, 1999. The SDA decision was based, in part, on the presentation of preliminary Phase I/II data from an ongoing clinical study of primary liver cancer being conducted by FeRx at multiple centers in the United States. Typically, as a foreign sponsor of an investigational product, applicants are required to submit substantial safety and efficacy data in humans, obtained in large Phase II/III trials.
The study will be conducted at three medical centers identified by the SDA as GCP qualified sites: The National SDA GCP Center for Oncology, Chinese Academy of Medical Sciences, Beijing (Trial Organizer: Dr. Yan Sun, Director, National SDA GCP Center for Oncology; Director, Radiotherapy Center, Beijing Tumor Hospital; and, Fellow of the Chinese Academy of Engineering); the Liver Cancer Institute, Zhongshan Hospital, affiliated with Fudan University, Shanghai (Investigator: Dr. Sheng-Long Ye, Professor of Oncology and Vice Chairman, Liver Cancer Institute); and, the No. 81 General Hospital of the People¡¯s Liberation Army, Nanjing (Investigator: Dr. Shukui Qin, Chief Physician in Oncology).
¡°We are extremely pleased to receive this approval from the Chinese SDA and are particularly grateful for the work of our Chinese colleagues, especially Dr. Ming-Wei Wang of SiniWestÒ Holdings, Inc., whose tireless efforts resulted in this groundbreaking decision,¡± commented Jacqueline Johnson, Ph.D., President and CEO of FeRx Incorporated. ¡°We now look forward to initiating the Phase II clinical study which we hope will ultimately result in moving our lead product towards market approval in China.¡±
Primary liver cancer is the most prevalent cancer in the world, annually killing more than one million people. It is the predominant cancer in Asia, aided by the endemic presence of the hepatitis B virus. Based on recent surveys published by the International Agency for Research on Cancer (World Health Organization), there are currently well over 1,000,000 cases of liver cancer in China, which accounts for 43.7% of the worldwide incidence of the disease, and over 300,000 deaths each year, with at least 300,000 newly diagnosed cases occurring annually.
¡°With the continuing rise in the incidence of various cancers in China, SiniWest Holdings, Inc., is happy to have played a role in obtaining the approval of the SDA in order for FeRx to conduct this Phase II study,¡± said Ming-Wei Wang, M.D., Ph.D., President and CEO of SiniWest Holdings, and key consultant to FeRx in coordinating the SDA approval. ¡°We are particularly gratified that the study will include the General Hospital of the People¡¯s Liberation Army in Nanjing, providing access to a unique population of patients that represents the productive future of the country.¡±
SiniWest specializes in identifying, evaluating and developing high-tech based business opportunities in Mainland China with an emphasis on biotechnologies, pharmaceuticals, diagnostics, and agrochemicals. SiniWest serves as a bridge for international investors and businesses to enter the rapidly growing Chinese economy and provides a window of opportunity for the Chinese biopharmaceutical industry to access Western Markets. For additional information, please visit the company¡¯s web site at: www.siniwest.com.
FeRx is a privately held, product-oriented, targeted drug delivery company dedicated to the development and commercialization of its proprietary MTC technology to improve patient care, reduce toxicity and increase efficacy of known drugs. FeRx is currently completing a Phase I/II clinical trial of its lead compound, MTC-Doxorubicin (MTC-DOX), in patients with primary liver cancer and has recently initiated a Phase I/II study of MTC-DOX in patients with metastatic liver cancer. MTCs are under clinical investigation to determine their ability to meet two important goals for targeted drug delivery ¨C reducing drug toxicity created by nonspecific systemic exposure, while still achieving an efficacious concentration of drug at the desired site of action. Furthermore, MTCs are broadly applicable as carriers for a wide range of drugs, due to the absorptive properties of the activated carbon component. While FeRx is focusing on cancer therapy applications in its initial clinical trials, the MTC drug delivery technology will continue to be investigated for site-specific delivery and sustained release of various classes of pharmaceutical agents in other therapeutic areas. For additional company background, please visit the FeRx Incorporated web site at: www.FeRx.com.
Company Contact:
Richard W. Keatinge, Ph.D.
Vice President,
Corporate Development
FeRx Incorporated
858-677-7788 rkeatinge@ferx.com or
Siniwest Contact:
Ming-Wei Wang, M.D., Ph.D.
President & CEO
SiniWest Holdings, Inc.
619-301-1798 mwwang@siniwest.com or
Media Contact:
Kathy Witz Sweeney
Mentus, Inc.
858-455-5500 ext. 140
kwitz@mentusonline.com