Rock Creek Pharmaceuticals Files 2014 Annual Report and Provides Clinical Development Update
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
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