Rock Creek Pharmaceuticals, has initiated the development of its lead molecule, Anatabine Citrate, in Europe; and that it has selected Quotient Clinical, The Translational Pharmaceutics Company, based in the United Kingdom to run its early development programmes.
The company expects to file a Clinical Trial Application (CTA) by the end of the third quarter with the Medicines Healthcare products Regulatory Agency (MHRA) seeking regulatory approval to initiate its clinical trials. Upon CTA approval, a safety and tolerability study will be initiated to investigate escalating doses of Anatabine Citrate. At the same time, Quotient Clinical will employ its RapidFACT (Rapid Formulation development And Clinical Testing) service to identify the next generation of oral Anatabine Citrate formulations for progression into multiple pivotal phase 2 proof of concept studies.
Michael J. Mullan MBBS (MD) PhD, Rock Creek Pharmaceutical's chairman and chief executive officer, said, "We are excited to be working with the Quotient Clinical team who provide a unique blend of services that integrate formulation development, real time GMP manufacturing and rapid clinical testing. These are exactly the resources and expertise our lead compound needs to expedite the drug development process to prepare us for phase II clinical trials expected to begin in 2015. "
Mark Egerton, chief executive officer, Quotient Clinical said "Anatabine Citrate represents a potential new and exciting medicine for inflammatory disorders. We are delighted that Rock Creek have selected Quotient Clinical to progress their drug candidate through early development. Our Translational Pharmaceutics platform is proven to reduce programme timelines and costs and we look forward to working with Rock Creek to accelerate their development plan".
Rock Creek Pharmaceutical's Antabine Citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics via the inhibition of NF-kB (nuclear factor kappa-light-chain-enhancer of activated B cells). NF-kB is a key protein complex which plays a pivotal role in regulating response to cellular inflammation. The Company has sponsored extensive pre-clinical in vitro and in vivo studies resulting in peer reviewed and published scientific journal articles, covering inflammatory models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune Thyroiditis. In addition, the company's unusual compilation of human exposure, safety and tolerability data, provides important insights for future clinical pathway progression.
Rock Creek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialisation of new drugs, formulations and compounds that provide therapies for inflammatory conditions and behavioural health. Additionally, through its subsidiary RCP Development, the Company is engaged in the manufacturing, sale, and marketing of nutraceutical dietary supplements designed to promote maintenance of a healthy metabolism and lifestyle.
Quotient Clinical offers a unique range of services, based on its Translational Pharmaceutics platform. Translational Pharmaceutics integrates formulation development, real-time GMP manufacturing with clinical testing, significantly reducing the time and cost of bringing a drug to market.
For more than 20 years, Quotient Clinical has brought innovation to early drug development programmes for pharmaceutical companies worldwide. At the company's purpose built facilities, real-time manufacturing of all types of dosage forms is co-located with its clinical pharmacology unit to maximise flexibility, speed and cost savings for clients. More than 200 highly trained specialists provide a full range of services from study set-up right through to data analysis and reporting.