Navigation Links
Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs
Date:7/31/2014

SARASOTA, Fla., July 31, 2014 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI) announced today that it has initiated the development of its lead molecule, Anatabine Citrate, in Europe; and that it has selected Quotient Clinical, The Translational Pharmaceutics Company, based in the United Kingdom (UK) to run its early development programs.

The Company expects to file a Clinical Trial Application (CTA) by the end of the third quarter with the Medicines Healthcare products Regulatory Agency (MHRA) seeking regulatory approval to initiate its clinical trials. Upon CTA approval, a safety and tolerability study will be initiated to investigate escalating doses of Anatabine Citrate. At the same time, Quotient Clinical will employ its RapidFACT™ (Rapid Formulation development And Clinical Testing) service to identify the next generation of oral Anatabine Citrate formulations for progression into multiple pivotal Phase 2 proof of concept studies.

Michael J. Mullan MBBS (MD) PhD, Rock Creek Pharmaceutical's Chairman and CEO, said, "We are excited to be working with the Quotient Clinical team who provide a unique blend of services that integrate formulation development, real time GMP manufacturing and rapid clinical testing. These are exactly the resources and expertise our lead compound needs to expedite the drug development process to prepare us for phase II clinical trials expected to begin in 2015. "

Mark Egerton, Chief Executive Officer, Quotient Clinical said "Anatabine Citrate represents a potential new and exciting medicine for inflammatory disorders. We are delighted that Rock Creek have selected Quotient Clinical to progress their drug candidate through early development. Our Translational Pharmaceutics platform is proven to reduce program timelines and costs and we look forward to working with Rock Creek to accelerate their development plan".  

About Anatabine Citrate:

Rock Creek Pharmaceutical's Antabine Citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics via the inhibition of NF-kB (nuclear factor kappa-light-chain-enhancer of activated B cells). NF-kB is a key protein complex which plays a pivotal role in regulating response to cellular inflammation. The Company has sponsored extensive pre-clinical in vitro and in vivo studies resulting in peer reviewed and published scientific journal articles, covering inflammatory models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune Thyroiditis. In addition, the company's unusual compilation of human exposure, safety and tolerability data, provides important insights for future clinical pathway progression.

About Rock Creek Pharmaceuticals, Inc.:

Rock Creek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for inflammatory conditions and behavioral health.  Additionally, through its subsidiary RCP Development, the Company is engaged in the manufacturing, sale, and marketing of nutraceutical dietary supplements designed to promote maintenance of a healthy metabolism and lifestyle. 

For more information, visit: http://www.rockcreekpharma.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

CONTACT:

Rock Creek Pharmaceuticals:

Ted Jenkins 
Vice President, Corporate Strategy, Development, Investor Relations 
Rock Creek Pharmaceuticals 
tjenkins@rockcreekpharma.com

Quotient Clinical

Sarah Khan 
kdm communications Ltd 
Tel: + 44 (0)1480 405333
Sarahk@kdm-communications.com

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 market acceptance of our nutraceutical dietary supplements products, 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 10-Q Report filed on May 12, 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.

Logo - http://photos.prnewswire.com/prnh/20140731/132375

 


'/>"/>
SOURCE Rock Creek Pharmaceuticals, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Creekridge Capital Signs Several New Vendor Partners
2. Rock Creek Pharmaceuticals Issues Update On US Investigational New Drug Application
3. Creekridge Breaks Monthly and Quarterly Volume Records
4. Creekridge Capital Grows Healthcare Sales Team
5. Creekridge Capital Launches Vendor Sales Training Program
6. Creekridge Capital Expands Healthcare Sales Team
7. Creekridge Capital Adds Revolving Credit Specialist
8. Creekridge Capital Announces Record Volume
9. Star Scientific and Rock Creek Pharmaceuticals Report on the Beneficial Nutritional Effects of Anatabine in an Animal Model of Ulcerative Colitis
10. Creekridge Capital Continues Vendor Growth within Technology
11. A Forever Recovery Battle Creek, MI: Increasing Recreational Drug Use in Colleges Creates Risk for Addictions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... --  Bernstein Liebhard LLP today announced that a securities ... Court for the District of Arizona ... persons or entities who purchased common shares of Insys Therapeutics ... March 3, 2015 through January 25, 2016 (the "Class Period").  ... violations of the Securities Exchange Act of 1934.  ...
(Date:2/4/2016)... 4, 2016  Montoya Love is recognized by Continental ... of Pharmaceuticals. Montoya is the Regulatory Systems Operations Manager ... Manufacturing and selling a broad ... provides healthcare institutions, clinical laboratories and life science ... across the globe. ...
(Date:2/4/2016)... , Feb. 4, 2016 Frontier Pharma: ... Commercializing First-in-Class Innovation Chronic Obstructive ... with chronic inflammation of the airways and lungs. ... symptoms make the disease one of the leading ... death in the world. COPD is linked to ...
Breaking Medicine Technology:
(Date:2/7/2016)... ... 2016 , ... Dr. Todd Hobgood , certificated in ... surgical expertise. Technically known as deoxycholic acid or previously as ATX-101, Kybella® ... for reduction of fat below the chin (aka the “double chin”). Medication side ...
(Date:2/6/2016)... ... , ... With the FCPX LUT: Summer pack from Pixel Film ... LUT is a Lookup Table that contains a mathematical formula for modifying an image. ... By manipulating each pixel, LUT's can change each color range differently, it gives the ...
(Date:2/5/2016)... ... February 05, 2016 , ... Steven Tonkinson, 36, of ... completed every year since it started in 2003. This year, he ran all 26.2 ... fellow runners and NBA team the Miami Heat. , This Sunday, while many are ...
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior TV show, hosted ... feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will stream on Friday, ... on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food Warriors - people ...
(Date:2/5/2016)... ... February 05, 2016 , ... The Muscular Dystrophy ... Kitchen restaurants, launched the 14th annual “Appetite for a Cure” campaign on Feb. ... dystrophy, ALS and related diseases that severely limit strength and mobility. , ...
Breaking Medicine News(10 mins):