Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[CoachKWJ]

Check PR from earlier:
http://finance.yahoo.com/news/rock-creek-pharmaceuticals-announces-inhibition-134500908.html

SARASOTA, Fla., Feb. 3, 2016 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (RCPI), a clinical stage drug development company which is focused on the application of its lead compound to treat acute and chronic inflammatory conditions, announced today that the Company has received an interim report of the pharmacodynamic (PD) results of its Phase I clinical trial of its lead compound, anatabine citrate.

The Company previously announced that the Phase I trial approved by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), demonstrated that the drug was safe, well tolerated and had a consistent pharmacokinetic (PK) profile. This PD report highlighted that anatabine citrate produced significant reductions in a key marker of inflammation, STAT 3 (Signal Transducer and Activator of Transcription 3), in human volunteers.

Although the Phase I trial was designed primarily for the assessment of safety, tolerability and PK, the PD report also covers data generated from the newly developed PD assay, as applied to two dosing regimens in the Company's Phase I trial. The PD assay examined the effect of the drug on inflammatory responses induced in blood samples taken from human volunteers. The blood samples were taken prior to ingestion of the drug and then taken at various times after ingestion. The blood samples were then stimulated with a bacterial inflammatory molecule called lipopolysaccharide (LPS) and two markers of inflammation were examined. These two inflammation markers are the transcription factors STAT 3 and NF-kB, which are widely known as key molecular drivers of inflammation, and are responsible for the production of a variety of inflammatory molecules such as TNF alpha, interleukin-1, interleukin-6 and COX-2, as examples.

In this present study, it was observed that STAT 3 activity was shown to be significantly reduced in blood samples taken after drug administration compared to blood samples taken before drug administration, when activated STAT 3 values were appropriately normalized by the amount of a reference protein (GAPDH) that is unaffected by LPS stimulation in the blood samples.

One of the oral dosing regimens within the study also showed NF-kB reduction, when data was normalized via this newly developed PD assay, although observations for NF-kB activity were generally less consistent than the STAT 3 results. This was attributed to the novel PD assay not being optimized for NF-kB and that in future studies, the incubation period for the NF-kB samples should be changed to account for this finding. Analyses of the remaining regimens is ongoing.

Dr. Michael Mullan, (MBBS, PhD), Chairman and Chief Executive Officer of Rock Creek Pharmaceuticals commented, "These results are very much in concert with what has been previously observed in preclinical and clinical studies of the drug. The fact that STAT 3 activity was significantly, statistically suppressed in the two treated groups, analyzed in depth, is meaningful. Further, this is the first time a drug version of the compound, under strict regulatory conditions, has been shown to be anti-inflammatory in human blood."

As previously announced, the Company has been unifying its scientific, clinical, regulatory and consultancy resources to focus on inflammatory skin diseases and is planning a Phase IB, proof-of-concept trial with patients diagnosed with mild to moderate psoriasis, expected to commence mid-2016.