Conducted at the Frontage Clinical Center in Hackensack, NJ, the trial examined the safety and tolerability of the botanical agent in soft gel capsules.
A total of 30 healthy volunteers enrolled in the open-label, single-dose, dose-escalation study, which was completed with “highly efficient project management skills and can-do attitude,” according to the study sponsor, who indicated a desire for future collaboration with Frontage.
Report: Global Market to Reach $32 billion by 2013
With an exclusive focus on these unique therapies, the sponsor is part of a global market for botanical and plant-derived drugs that is expected to reach $32 billion in 2013, with a 5-year compound annual growth rate of 11%, according to a recent technical market research report.
The report, “Botanical and Plant-Derived Drugs: Global Markets” (BIO022E) from BCC Research, projected that the specific botanical drug segment would grow at an astonishing 651.7% compounded annually, reaching $2.4 billion of the combined market.
This Frontage Phase I study marks a vital step on the sponsor’s path toward US FDA approval. The agency has noted the significant role of plant-derived compounds by carving out a new drug approval pathway for botanical drugs in 2004 and approving the first botanical based on these guidelines in 2006.
About Frontage
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 72-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.
