Click here to close now.

Welcome!

News Feed Item

Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs

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.

Rock Creek Pharmaceuticals

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 
[email protected]

Quotient Clinical

Sarah Khan 
kdm communications Ltd 
Tel: + 44 (0)1480 405333
[email protected]

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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists discussed how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations migh...
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of...
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, analyzed how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining BI In...
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
SYS-CON Events announced today that Secure Infrastructure & Services will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Secure Infrastructure & Services (SIAS) is a managed services provider of cloud computing solutions for the IBM Power Systems market. The company helps mid-market firms built on IBM hardware platforms to deploy new levels of reliable and cost-effective computing and hig...
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development...
Live Webinar with 451 Research Analyst Peter Christy. Join us on Wednesday July 22, 2015, at 10 am PT / 1 pm ET In a world where users are on the Internet and the applications are in the cloud, how do you maintain your historic SLA with your users? Peter Christy, Research Director, Networks at 451 Research, will discuss this new network paradigm, one in which there is no LAN and no WAN, and discuss what users and network administrators gain and give up when migrating to the agile world of clo...
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, it is now feasible to create a rich desktop and tuned mobile experience with a single codebase, without compromising performance or usability.
Containers are revolutionizing the way we deploy and maintain our infrastructures, but monitoring and troubleshooting in a containerized environment can still be painful and impractical. Understanding even basic resource usage is difficult – let alone tracking network connections or malicious activity. In his session at DevOps Summit, Gianluca Borello, Sr. Software Engineer at Sysdig, will cover the current state of the art for container monitoring and visibility, including pros / cons and liv...
SYS-CON Media announced today that CloudBees, the Jenkins Enterprise company, has launched ad campaigns on SYS-CON's DevOps Journal. CloudBees' campaigns focus on the business value of Continuous Delivery and how it has been recognized as a game changer for IT and is now a top priority for organizations, and the best ways to optimize Jenkins to ensure your continuous integration environment is optimally configured.
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the...
"In the IoT space we are helping customers, mostly enterprises and industry verticals where time-to-value is critical, and we help them with the ability to do faster insights and actions using our platform so they can transform their business operations," explained Venkat Eswara, VP of Marketing at Vitria, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
The most often asked question post-DevOps introduction is: “How do I get started?” There’s plenty of information on why DevOps is valid and important, but many managers still struggle with simple basics for how to initiate a DevOps program in their business. They struggle with issues related to current organizational inertia, the lack of experience on Continuous Integration/Delivery, understanding where DevOps will affect revenue and budget, etc. In their session at DevOps Summit, JP Morgenthal...
"We provide a web application framework for building really sophisticated web applications that run on a browser without any installation need so we get used for biotech, defense, and banking applications," noted Charles Kendrick, CTO and Chief Architect at Isomorphic Software, in this SYS-CON.tv interview at @DevOpsSummit (http://DevOpsSummit.SYS-CON.com), held June 9-11, 2015, at the Javits Center in New York