Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[haysaw]

Per the June 11th 8K (released this morning):

Rock Creek Pharmaceuticals Announces Clinical Update

SARASOTA, Fla., June 10, 2015 – Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory
disease and neurologic disorders, announced today an update on its clinical and regulatory drug development activities.
Phase I Trial Update
The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) approved in January 2015 a Clinical Trial Application (CTA) to
commence a Phase I study of the Company's lead compound,Anatabine Citrate. The trial consists of three parts, with Part Two being optional. The objectives
of Parts One and Two are to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of various modified and immediate release formulations of
anatabine citrate in healthy adult subjects, and to identify an optimal formulation for multiple day dosing in Part Three. Exploratory pharmacodynamic (PD)
outcome measures are also being assessed.
As previously announced, the Company completed recruitment and commenced human dosing for the study by March 1, 2015. As of June 1, 2015, Part One
of the Phase I study is complete, and the Company announces that there were no reports of serious adverse events (AEs) or AEs leading to study withdrawal.
Further, there were no safety concerns raised by the Company’s UK contract research organization or its UK based trial medical monitor.
The Company now expects to conduct an abbreviated Part Two of the study primarily to evaluate the effects of food on PK parameters. Dosing in Part Two is
expected to commence and be completed within the third quarter 2015.
Subsequently, the Company expects to conduct Part Three of the 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 in the third quarter 2015. It is anticipated
that follow up data management and analysis will be completed during the fourth quarter 2015. As per the trial design, outcome measures will focus primarily
on overall safety and tolerability with secondary measures focusing on standard PK parameters and also PD assessment, specifically measuring the impact of
the drug on inflammatory processes

New Zealand Study
As previously announced, the Company completed its New Zealand study of the Company’s nutritional supplement variant of Anatabine Citrate. In
December 2014, the Company received a New Zealand Ministry of Health Ethics Committee approval to conduct a single-site, single dose, open-label human
study, entitled “Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal, Healthy
Volunteers.” The primary outcome measure of the study was a pharmacodynamic assessment of whether a single dose of orally administered anatabine citrate
can acutely attenuate expression and/or production of pro-inflammatory mediators in human white blood cells, thus creating an anti-inflammatory effect.
Follow up analysis is complete and the Company is expecting to provide a formal report in the third quarter.