- Phase I Trial begins in the United Kingdom -
SARASOTA, Florida, Jan. 30, 2015 /PRNewswire/ -- Rock Creek
Pharmaceuticals, Inc. (NASDAQ: RCPI), a drug development company
focused on chronic inflammatory disorders, announced today that the
United Kingdom's Medicines
Healthcare Products Regulatory Agency (MHRA) has approved a
clinical trial application (CTA) to commence a Phase I study of the
Company's lead compound, Anatabine Citrate. The Company's lead
compound has an anti-inflammatory mode of action distinct from
other anti-inflammatory drugs available such as biologics, steroids
and non-steroidal anti-inflammatory drugs.
The Company's Phase I trial is comprised of a three-part study
to determine the pharmacokinetic profiles of selected modified
release formulation prototypes, and to evaluate safety and
tolerability in healthy subjects. Parts one and two (with part two
being optional) will both enroll 14 healthy subjects and are
designed as open-label, non-controlled, single-dose studies of six
different formulations with each dose separated by 7-14 days. The 6
drug formulations planned for testing in part one differ from each
other in terms of dose and duration of action. Testing each in turn
will allow determination of which formulations have the most
acceptable release and safety profiles. Part three is a
double-blind, placebo-controlled, seven- day multiple dose study of
the optimal formulation in healthy subjects.
As per the trial design, outcome measures will focus primarily
on overall safety and tolerability through physical examination,
vital signs, clinical chemistry, hematology, urinalysis and
observation of adverse events (AE). Secondary outcome measures will
include standard pharmacokinetics (PK) parameters and also
pharmacodynamic (PD) assessment, specifically measuring the impact
of the drug on inflammatory processes.
"We are delighted to have been granted regulatory approval to
begin our Phase I studies in the UK. This is the first clinical
phase for our lead drug and will focus on safety and tolerability
of six different formulations, 5 of which have modified release
profiles and are of different doses. We look forward to generating
our first human clinical data under this CTA," Said Dr Michael Mullan, CEO of Rock Creek
Pharmaceuticals.
Quotient Clinical, the Company's UK-based outsourced partner
will immediately begin recruitment of healthy volunteers,
with dosing to commence in February
2015, and with initial formulation PK data to emerge shortly
after. Although study data management and analysis are expected to
continue into August 2015, the
Company anticipates having a substantial amount of data by
mid-year. As previously disclosed, Quotient Clinical will
employ its RapidFACT® (Rapid Formulation development And Clinical
Testing) service to accelerate the development of these novel,
oral, modified release formulations that have been co-developed
between the two companies.
Also on January 30, 2015, Rock
Creek filed a Form 8-K with the SEC disclosing information
regarding a private placement that the Company closed on
January 28, 2015, as well as an
update on the Company's capital resources. A copy of such
Form 8-K can be obtained from the SEC's website at www.sec.gov or
on the Company's website at www.rockcreekpharmaceuticals.com.
About Anatabine Citrate:
Rock Creek Pharmaceuticals' anatabine citrate is a small
molecule, cholinergic agonist which exhibits anti-inflammatory
pharmacological characteristics. 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. 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
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
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, 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 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 latest 10-Q Report filed
on August 11, 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.
CONTACT:
Ted Jenkins
Vice President, Corporate Strategy, Development, Investor
Relations
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: +1-941-251-0488
tjenkins@rockcreekpharmaceuticals.com
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