SARASOTA, Florida, 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.
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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.
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:
Stephanie Carrington
Investors
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic
Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
+1-646-277-1282
stephanie.carrington@icrinc.com
Ted Jenkins
Vice President, Corporate Strategy and Development,
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: +1-941-251-0488
tjenkins@rockcreekpharmaceuticals.com