SARASOTA, Fla., June 11, 2015 /PRNewswire/ -- 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 either the Company's UK contract research
organization or its UK based trial medical monitor.
The Company now expects to conduct 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.
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
(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: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com
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SOURCE Rock Creek Pharmaceuticals, Inc.