|By PR Newswire||
|July 31, 2014 03:32 PM EDT||
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
Rock Creek Pharmaceuticals:
Vice President, Corporate Strategy, Development, Investor Relations
Rock Creek Pharmaceuticals
kdm communications Ltd
Tel: + 44 (0)1480 405333
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.
SOURCE Rock Creek Pharmaceuticals, Inc.
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
Oct. 25, 2016 04:45 PM EDT Reads: 1,536
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
Oct. 25, 2016 04:15 PM EDT Reads: 1,435
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Oct. 25, 2016 03:28 PM EDT Reads: 216
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, will discuss how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team a...
Oct. 25, 2016 03:15 PM EDT Reads: 377
A completely new computing platform is on the horizon. They’re called Microservers by some, ARM Servers by others, and sometimes even ARM-based Servers. No matter what you call them, Microservers will have a huge impact on the data center and on server computing in general. Although few people are familiar with Microservers today, their impact will be felt very soon. This is a new category of computing platform that is available today and is predicted to have triple-digit growth rates for some ...
Oct. 25, 2016 03:00 PM EDT Reads: 34,197
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Oct. 25, 2016 03:00 PM EDT Reads: 2,012
Governments around the world are adopting Safe Harbor privacy provisions to protect customer data from leaving sovereign territories. Increasingly, global companies are required to create new instances of their server clusters in multiple countries to keep abreast of these new Safe Harbor laws. Is it worth it? In his session at 19th Cloud Expo, Adam Rogers, Managing Director of Anexia, Inc., will discuss how to keep your data legal and still stay in business.
Oct. 25, 2016 02:30 PM EDT Reads: 1,472
The Internet of Things (IoT), in all its myriad manifestations, has great potential. Much of that potential comes from the evolving data management and analytic (DMA) technologies and processes that allow us to gain insight from all of the IoT data that can be generated and gathered. This potential may never be met as those data sets are tied to specific industry verticals and single markets, with no clear way to use IoT data and sensor analytics to fulfill the hype being given the IoT today.
Oct. 25, 2016 02:15 PM EDT Reads: 2,654
Successful transition from traditional IT to cloud computing requires three key ingredients: an IT architecture that allows companies to extend their internal best practices to the cloud, a cost point that allows economies of scale, and automated processes that manage risk exposure and maintain regulatory compliance with industry regulations (FFIEC, PCI-DSS, HIPAA, FISMA). The unique combination of VMware, the IBM Cloud, and Cloud Raxak, a 2016 Gartner Cool Vendor in IT Automation, provides a co...
Oct. 25, 2016 01:45 PM EDT Reads: 1,257
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
Oct. 25, 2016 01:30 PM EDT Reads: 2,695
SYS-CON Events announced today that MathFreeOn will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. MathFreeOn is Software as a Service (SaaS) used in Engineering and Math education. Write scripts and solve math problems online. MathFreeOn provides online courses for beginners or amateurs who have difficulties in writing scripts. In accordance with various mathematical topics, there are more tha...
Oct. 25, 2016 01:15 PM EDT Reads: 1,058
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 25, 2016 12:45 PM EDT Reads: 4,949
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
Oct. 25, 2016 12:30 PM EDT Reads: 8,484
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Oct. 25, 2016 12:00 PM EDT Reads: 2,690
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm ...
Oct. 25, 2016 11:45 AM EDT Reads: 3,817