SARASOTA, Fla., July 31, 2014 /PRNewswire/ -- Rock Creek
Pharmaceuticals, Inc., (NASDAQ: RCPI) announced today that it has
initiated the development of its lead molecule, Anatabine Citrate,
in Europe; and that it has
selected Quotient Clinical, The Translational Pharmaceutics
Company, based in the United
Kingdom (UK) to run its early development programs.
The Company expects to file a Clinical Trial Application (CTA)
by the end of the third quarter with the Medicines Healthcare
products Regulatory Agency (MHRA) seeking regulatory approval to
initiate its clinical trials. Upon CTA approval, a safety and
tolerability study will be initiated to investigate escalating
doses of Anatabine Citrate. At the same time, Quotient Clinical
will employ its RapidFACT™ (Rapid
Formulation development And Clinical
Testing) service to identify the next generation of oral
Anatabine Citrate formulations for progression into multiple
pivotal Phase 2 proof of concept studies.
Michael J. Mullan MBBS (MD) PhD, Rock Creek Pharmaceutical's
Chairman and CEO, said, "We are excited to be working with the
Quotient Clinical team who provide a unique blend of services that
integrate formulation development, real time GMP manufacturing and
rapid clinical testing. These are exactly the resources and
expertise our lead compound needs to expedite the drug development
process to prepare us for phase II clinical trials expected to
begin in 2015. "
Mark Egerton, Chief Executive
Officer, Quotient Clinical said "Anatabine Citrate represents a
potential new and exciting medicine for inflammatory disorders. We
are delighted that Rock Creek have selected Quotient Clinical to
progress their drug candidate through early development. Our
Translational Pharmaceutics platform is proven to reduce program
timelines and costs and we look forward to working with Rock Creek
to accelerate their development plan".
About Anatabine Citrate:
Rock Creek Pharmaceutical's Antabine Citrate is a small
molecule, cholinergic agonist which exhibits anti-inflammatory
pharmacological characteristics via the inhibition of NF-kB
(nuclear factor kappa-light-chain-enhancer of activated B cells).
NF-kB is a key protein complex which plays a pivotal role in
regulating response to cellular inflammation. The Company has
sponsored extensive pre-clinical in vitro and in vivo studies
resulting in peer reviewed and published scientific journal
articles, covering inflammatory models of Multiple Sclerosis,
Alzheimer's Disease, and Auto-Immune Thyroiditis. In addition, the
company's unusual compilation of human exposure, safety and
tolerability data, provides important insights for future clinical
pathway progression.
About Rock Creek Pharmaceuticals, Inc.:
Rock Creek Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery, development and commercialization of new
drugs, formulations and compounds that provide therapies for
inflammatory conditions and behavioral health. Additionally,
through its subsidiary RCP Development, the Company is engaged in
the manufacturing, sale, and marketing of nutraceutical dietary
supplements designed to promote maintenance of a healthy metabolism
and lifestyle.
For more information, visit: http://www.rockcreekpharma.com
About Quotient Clinical
Quotient Clinical offers a unique range of services, based on
its Translational Pharmaceutics™ platform. Translational
Pharmaceutics™ integrates formulation development, real-time GMP
manufacturing with clinical testing, significantly reducing the
time and cost of bringing a drug to market.
For more than 20 years, Quotient Clinical has brought innovation
to early drug development programs for pharmaceutical companies
worldwide. At the company's purpose built facilities,
real-time manufacturing of all types of dosage forms is co-located
with its clinical pharmacology unit to maximize flexibility, speed
and cost savings for clients. More than 200 highly trained
specialists provide a full range of services from study set-up
right through to data analysis and reporting.
For further information, visit www.quotientclinical.com
CONTACT:
Rock Creek Pharmaceuticals:
Ted Jenkins
Vice President, Corporate Strategy, Development, Investor
Relations
Rock Creek Pharmaceuticals
tjenkins@rockcreekpharma.com
Quotient Clinical
Sarah Khan
kdm communications Ltd
Tel: + 44 (0)1480 405333
Sarahk@kdm-communications.com
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, results of clinical trials and/or other studies, the
challenges inherent in new product development initiatives,
including the continued development and market acceptance of our
nutraceutical dietary supplements products, the effect of any
competitive products, our ability to license and protect our
intellectual property, 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
and the outcome of the ongoing investigations 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, 2013 filed on
March 17, 2014 and our 10-Q Report
filed on May 12, 2014. 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.
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SOURCE Rock Creek Pharmaceuticals, Inc.