April 04, 2012 -- Frontage, the global contract research organization, today announced that it has successfully filed an Investigational New Drug (IND) application to launch a U.S. clinical program on behalf of Zhejiang Hisun Pharmaceutical Co., Ltd.
The IND enables Hisun to initiate an early phase clinical study for HS-25, an innovative cholesterol-lowering compound to treat the onset of hypercholesterolemia and nephrotic hyperlipidemia.
Unlike other statins, HS-25 inhibits intestinal cholesterol absorption and promotes biliary cholesterol excretion thus lowering total cholesterol and low density lipoprotein (LDL) to improve the body's cardiovascular function.
In addition to the U.S. filing, HS-25 has been submitted for Chinese and global protection under the Patent Cooperation Treaty. If ultimately successful, HS-25 will join a class of compounds that includes the number one cholesterol lowering drug, Lipitor, which generated global revenue of $9.6 billion last year for Pfizer.
As the U.S. regulatory agent for Hisun, Frontage supported the HS-25 IND filing with drug development and regulatory consulting services, including CMC and pharmaceutical toxicology, plus the clinical development plan and protocols. In addition, Frontage provided communications with the FDA ranging from the pre-IND meeting through the IND filing and post-IND discussions. Frontage will also conduct the Phase I trial and other clinical pharmacology studies for HS-25 at its U.S. clinical center.
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform. Frontage runs three Phase 1 Clinical units, a 88-bed Phase 1 Unit in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China. Frontage has an AALAC certified preclinical animal facility in Pennsylvania, where it also maintains bioanalytical and CMC facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. As a rapidly expanding CRO with ten years of success providing high-quality GXP services, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems.