Rock Creek Pharmaceuticals Reports Human Proof of Principle Study of Lead Compound Demonstrating Inhibition of Inflammatory Markers In White Blood Cells

Jul 01, 2015, 08:30 ET from Rock Creek Pharmaceuticals, Inc.

SARASOTA, Fla., July 1, 2015 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today the results of a human proof of principle study with anatabine citrate, the Company's lead compound. Results from the study show that a single oral dose of anatabine citrate can significantly inhibit the activation of inflammatory proteins in the blood of human subjects. The Company is developing this compound in a Phase 1 clinical trial under a Medicines and Healthcare Products Regulatory Agency (MHRA) regulatory protocol in the United Kingdom.

New Zealand Study

In December of 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 objective of the study was to determine whether a single dose of orally administered anatabine citrate could reduce the activation of inflammatory proteins in human white blood cells. Blood samples were taken from ten healthy human subjects, collected before and after oral administration of anatabine citrate. The blood samples were immediately challenged with lipopolysaccharide (LPS), a well-known potent stimulator of inflammation. The blood samples were then evaluated to measure the activation of two proteins, NF-kB and STAT3, which are known to be central to inflammation. The study compared the amount of LPS-induced activation of NF-kB and STAT3 in the white blood cells before and after the administration of anatabine citrate. Activated NF-kB and STAT3 protein levels were measured by two different, well-established molecular biology methods.

Data analysis showed that there were statistically significant (p<0.05) reductions in LPS stimulated levels of both NF-kB and STAT3 in human white blood cells after a single oral dose of anatabine citrate. These data are consistent with several peer reviewed scientific papers showing that anatabine can reduce NF-kB and STAT3 activation in animal models of inflammatory diseases, as well as in several human cell lines as shown by in vitro studies. Additionally, evaluation of safety data showed that anatabine citrate was well tolerated by the study participants and there were no safety concerns.

Ryan Lanier, PhD, Rock Creek Pharmaceuticals'  Chief Scientific Officer remarked, "This is the first time that anatabine citrate taken orally by human subjects has been shown to oppose the activation of these known inflammatory proteins in white blood cells. The data are entirely consistent with our proposed mechanism of action of anatabine citrate which forms the basis for our advancement of this compound into clinical trials for human inflammatory diseases."

About Anatabine Citrate:
Rock Creek Pharmaceuticals' Anatabine Citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company has sponsored extensive pre-clinical (in vitro and in vivo) studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune Thyroiditis. All these studies demonstrated the anti-inflammatory effects of Anatabine Citrate. In addition, the Company's compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies and post-marketing data collection of the previously marketed nutraceutical product, has provided important insights for clinical development.

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 inflammatory disease, neurologic disorders and behavioral health.

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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.


Stephanie Carrington
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
(646) 277-1282

Ted Jenkins
Vice President, Corporate Strategy and Development,
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL  34243
Direct: 941-251-0488

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SOURCE Rock Creek Pharmaceuticals, Inc.