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): October 15, 2015
ROCK CREEK PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
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))
| Item 7.01. | Regulation FD Disclosure. |
On October 15, 2015, the Company announced
information regarding the completion of a Phase I Clinical Trial, which
information was included in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Current Report on
Form 8-K shall not be treated as filed for purposes of the Securities Exchange Act of 1934, as amended.
| Item 9.01. | Financial Statements and Exhibits. |
| 99.1 | Press Release, dated October 15, 2015. |
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: October 15, 2015
Exhibit 99.1
Rock Creek Pharmaceuticals Announces Successful
Completion of Phase I Clinical Trial to Evaluate Oral Formulations of its Lead Compound, Plans to Conduct Proof-of-Concept Trial
in Subjects with Mild to Moderate Psoriasis
SARASOTA,
Fla., October 15, 2015 – 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.
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
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