SARASOTA, Florida, March 12, 2015 /PRNewswire/ --
Clinical Update:
- Gained approval of a Clinical Trial Application (CTA) in
Europe during January 2015 allowing study of Company's lead
compound, Anatabine Citrate
- Completes recruitment and initial dosing in Part One of the
Phase I trial, being conducted in the United Kingdom
- Commences clinical study of nutritional variant of Anatabine
Citrate in New Zealand under
"MedSafe" approval
Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug
development company focused on the treatment of chronic
inflammatory disorders, today filed its annual report on Form 10-K
with the Securities and Exchange Commission and provided an update
on its drug development activities.
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Dr. Michael Mullan, CEO of Rock
Creek Pharmaceuticals, commented, "2014 was a period of significant
transformation as we embarked on a new strategy to advance our lead
candidate, Anatabine Citrate, into human clinical development
pursuant to formal regulatory protocols both in the United States and Europe. We have transformed Rock Creek
Pharmaceuticals into a clinical stage company and realigned our
corporate facilities and personnel."
Dr. Mullan continued, "During the first quarter of 2015, we
commenced our Phase I trial in the UK and began dosing in Part One
of the study. We look forward to providing subsequent updates in
the coming months regarding progress of the Phase I trial as we
generate the first human clinical data with the prototype drugs
being tested under this CTA. As previously announced, under our
current development plan and contingent on obtaining sufficient
capital resources, we plan on initiating one or more Phase IIa
trials during the second half of 2015. We are delighted that our
Phase I trial is moving ahead in Europe, and we are hopeful that in conjunction
with the additional pre-clinical work conducted in the Fall of
2014, we will be able to move forward with an updated protocol for
the Company's US IND refiling this year."
Phase I Trial Update
The United Kingdom's Medicines Healthcare Products
Regulatory Agency (MHRA) approved in January
2015 a CTA to commence a Phase I study of the Company's lead
compound, Anatabine Citrate. As previously announced, the Phase I
trial is being conducted in three parts, Part Two being optional.
Patient recruitment in Part One of this study and initial dosing of
the first cohort of 14 healthy subjects were completed March 1, 2015. Subsequent dose and duration
formulations will be administered over the next eight to ten weeks
to this cohort of subjects, allowing the identification of drug
variants (from the six drug formulations being evaluated) with the
most acceptable release and safety profiles. Subsequently, the
Company expects to conduct Part Three of this 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 by the end of the
second quarter 2015. It is anticipated that follow up data
management and analysis will be completed during the third quarter
2015. As per the trial design, outcome measures will focus
primarily on overall safety and tolerability with secondary
measures focusing on standard pharmacokinetics (PK) parameters and
also pharmacodynamic (PD) assessment, specifically measuring the
impact of the drug on inflammatory processes.
Study in New
Zealand
The nutritional supplement variant of
Anatabine Citrate has received "MedSafe" approval from the New
Zealand Medicines and Medical Devices Safety Authority, which has
allowed the Company to conduct a clinical study in New Zealand. In December 2014, the Company received a New Zealand
Ministry of Health Ethics Committee approval to conduct a
single-site, 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 is the pharmacodynamic assessment of
inflammatory markers including the expression and/or production of
pro-inflammatory mediators from peripheral blood cells. This study
will offer further insights into Anatabine Citrate's
anti-inflammatory mechanism of action in human blood. The dosing of
the healthy volunteers has been underway and the Company expects to
provide analysis and commentary mid year 2015.
Annual Meeting
The Company's annual meeting will be
held on April 10, 2015 in
Sarasota, Florida and will be
accessible through a live webcast. In addition to the conduct of
corporate matters at that meeting, the Company will hold a
shareholder vote to conduct a reverse split at an appropriate ratio
to insure compliance with Nasdaq minimum bid listing rules, and to
maintain the Company's Nasdaq listing. Further, the Company will
provide commentary on its regulatory strategy and ongoing drug
development initiatives designed to advance its lead compound
through Phase I and into Phase II trials.
Capital Resources
In addition to the Company's current
previously announced "at-the-market" (ATM) offering equity
facility, the Company continues to explore a variety of potential
financing options, including additional private placements and
financing transactions that would leverage the Company's
intellectual property and would fund the Company's development
plan. The Company began utilizing the ATM equity facility in
February of 2015 and, without giving effect to further sales under
the ATM equity facility, the Company's current capital resources
will fund the Company's development activities through the end of
the first quarter 2015. Given the corporate restructuring and
anticipated impending settlement of various legal matters, the
Company expects expenses (not including drug development research)
to be significantly reduced in 2015 as compared to 2014.
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. 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 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, Investor
Relations
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 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
(646) 277-1282
stephanie.carrington@icrinc.com