Rock Creek Pharmaceuticals, Inc. announced that it has initiated the development of its lead molecule, Anatabine Citrate, in Europe; and that it has selected Quotient Clinical to run its early development programs. 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(TM) (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.

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.