UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): January 30, 2015
ROCK CREEK PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
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Delaware
(State or other jurisdiction of incorporation) |
000-15324
(Commission File Number) |
52-1402131
(IRS Employer Identification No.) |
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2040 Whitfield Avenue, Suite 300
Sarasota, Florida 34243
(Address of principal executive offices,
including zip code)
844-727-0727
(Registrant’s telephone number,
including area code) |
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Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
On January 30, 2015, the Company announced,
though a press release attached as Exhibit 99.1 to this Current Report on Form 8-K, that the United Kingdom’s Medicines Healthcare
Products Regulatory Agency (MHRA) approved the Company’s clinical trial application (CTA) to commence a Phase I study of
the Company’s lead compound, Anatabine Citrate. As stated in the Company’s announcement, 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.
| Item 9.01. | Financial Statements and Exhibits. |
| 99.1 | Press Release, dated January
30, 2015, relating to approval of clinical trial application. |
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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ROCK CREEK PHARMACEUTICALS, INC. |
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By: |
/s/ Michael J. Mullan |
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Michael J. Mullan |
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Chairman of the Board and Chief Executive Officer |
Date: January 30, 2015
Rock Creek Pharmaceuticals Receives Clinical
Trial Application Approval
- Phase I Trial begins
in the United Kingdom -
Sarasota, FL, January 30, 2015 - 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: 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
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