Rock Creek Pharmaceuticals Announces Inhibition of STAT 3 Activation, A Key Marker of Inflammation, In Phase I Clinical Trial in Europe

Feb 03, 2016, 08:45 ET from Rock Creek Pharmaceuticals, Inc.

SARASOTA, Fla., Feb. 3, 2016 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (OTCQB: 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.

About Rock Creek Pharmaceuticals, Inc.:

Rock Creek Pharmaceuticals, Inc. is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic and acute inflammatory diseases.

About Anatabine Citrate:

Rock Creek Pharmaceuticals' compound is a small molecule, cholinergic agonist that exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company's lead compound has been investigated extensively in pre-clinical (in vitro and in vivo) studies resulting in several peer reviewed and published scientific journal articles, covering models of multiple sclerosis, Alzheimer's disease, and autoimmune thyroiditis. All these studies demonstrated the anti-inflammatory effects of the Company's compound. In addition, the Company's compilation of human exposure, safety and tolerability data, has provided important insights for ongoing clinical and regulatory pharmaceutical development.

For more information, visit: http://www.rockcreekpharmaceuticals.com

Forward Looking Statements:

Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, failure to obtain sufficient capital resources to fund our development program and operations, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our significant payables, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices, pending litigation matters, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2014 filed on March 12, 2015. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

CONTACT:

Investor Contact: 
PCG Advisory Group 
Stephanie Prince 
646.762.4518 
sprince@pcgadvisory.com

Media Contact: 
PCG Advisory Group 
Sean Leous 
646 863 8998 
sleous@pcgadvisory.com

Company Contact: 
Rock Creek Pharmaceuticals, Inc.  
2040 Whitfield Ave. Suite 300 
Sarasota Florida, 34243 
1-844-727-0727 
IR@rockcreekpharma.com

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SOURCE Rock Creek Pharmaceuticals, Inc.



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