SARASOTA, Florida, Oct. 15, 2015 /PRNewswire/ -- Rock Creek
Pharmaceuticals, Inc., (NASDAQ: RCPI), a clinical stage drug
development company focused on the application of its lead compound
being developed to treat chronic inflammatory conditions, announced
today the successful completion of its three part Phase I clinical
trial conducted in the United
Kingdom (UK). The overall objective of the Phase I
trial was to evaluate safety, tolerability and pharmacokinetic (PK)
profiles of different formulations of the Company's lead compound,
Anatabine Citrate, in healthy volunteers.
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In part one of the Phase I trial, subjects took six different
oral formulations of the Company's experimental medication while
safety and tolerability were assessed. The formulations differed in
dose and time release profile, which produced a range of PK
outcomes. All formulations were generally well tolerated with no
serious adverse events or safety issues leading to study
withdrawal. Part two of the trial examined the effects of food on
PK profiles produced by single oral doses of the medication. There
were no safety concerns with these "food effect" studies and the
medication was again well tolerated. Part three of the Phase I
trial was a randomized, double blind, placebo-controlled study
design consisting of seven days of oral dosing of the study
medication (or placebo) which demonstrated that the Company's
compound was safe and well tolerated.
All active treatment parts of the Phase I trial were conducted
with the healthy volunteers as inpatients in a clinical trial unit.
Although the Company expects to have a formal analysis at a later
time, the conclusions from the clinical research organization
conducting the studies were that there were no clinically
significant changes in any safety assessments including clinical
lab tests, vital signs and ECGs in any of the parts of the Phase I
trial.
With the completion of this Phase I oral dosing trial, the
Company is now poised to conduct a proof-of-concept clinical trial
to investigate the safety and efficacy of topical formulations of
its lead compound in patients suffering from mild-to-moderate
psoriasis. Psoriasis is characterized by an increase in
activity of the intracellular transcription factors NF-κB and
STAT3, which are responsible for driving the inflammation
associated with this disease. Much preclinical data suggests
that the Company's lead compound can attenuate the activity of
these two transcription factors thus producing anti-inflammatory
effects. The Company currently anticipates that a safety and
efficacy clinical trial for mild-to-moderate psoriasis will
commence in the first half of 2016.
"The Company's lead compound performed very well in the Phase I
clinical trial, with regard to safety, tolerability, and the
consistency of the PK profiles. Although the collected data will be
analyzed more thoroughly in the following weeks and months, the
preliminary feedback from the clinical research organization
conducting the trial and the Company's medical monitor in the UK
suggest there are no safety impediments to continued human clinical
trials," Noted Dr Ryan Lanier, Chief
Scientific Officer of the Company.
Dr Michael Mullan, the Company's
CEO commented "This is an important clinical milestone for the
Company signifying, as it does, the first regulatory test of its
lead compound in human subjects. We can now look forward to testing
the safety and efficacy of this compound in human subjects
suffering from psoriasis, a chronic inflammatory condition. We are
specifically focused on mild-to-moderate psoriasis, which
represents an unmet clinical need and will offer us the opportunity
to demonstrate proof of concept of this molecule's novel
anti-inflammatory properties."
About Anatabine Citrate:
Rock Creek Pharmaceuticals' compound 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 the Company's compound. In addition, the Company's
compilation of human exposure, safety and tolerability data, has
provided important insights for ongoing clinical and regulatory
pharmaceutical 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 and acute inflammatory diseases.
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:
Ted Jenkins
Vice President, Corporate Strategy & Development
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com