Rock Creek Pharmaceuticals, Inc. provided clinical development update. The United Kingdom's Medicines Healthcare Products Regulatory Agency (MHRA) approved in January 2015 a CTA to commence a Phase I study of the Company's lead compound, Anatabine Citrate. The Phase I trial is being conducted in three parts, Part Two being optional.

Patient recruitment in Part One of this study and initial dosing of the first cohort of 14 healthy subjects were completed March 1, 2015. Subsequent dose and duration formulations will be administered over the next eight to ten weeks to this cohort of subjects, allowing the identification of drug variants (from the six drug formulations being evaluated) with the most acceptable release and safety profiles. Subsequently, the company expects to conduct Part Three of this study comprised of a double-blind, placebo-controlled, seven-day multiple dose study of the optimal formulation in healthy subjects and is targeting study completion and generating preliminary results by the end of the second quarter 2015.

It is anticipated that follow up data management and analysis will be completed during the third quarter 2015. As per the trial design, outcome measures will focus primarily on overall safety and tolerability with secondary measures focusing on standard pharmacokinetics (PK) parameters and also pharmacodynamic (PD) assessment, specifically measuring the impact of the drug on inflammatory processes.