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July 31, 2014
15:39 EDTRCPIRock Creek Pharmaceuticals looks to file CTA by Q3 end
Rock Creek Pharmaceuticals announced 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 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.
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July 1, 2015
08:38 EDTRCPIRock Creek Pharmaceuticals' lead compound shows positive results
Rock Creek Pharmaceuticals announced results of a human proof of principle study with anatabine citrate, the company's lead compound, showing that a single oral dose of anatabine citrate can significantly inhibit the activation of inflammatory proteins in the blood of human subjects. These data are consistent with several scientific papers showing that anatabine can reduce NF-kB and STAT3 activation in animal models of inflammatory diseases, as well as in several human cell lines as shown by in vitro studies. Anatabine citrate was well tolerated by the study participants and there were no safety concerns. The company is developing this compound in a Phase 1 clinical trial under a Medicines and Healthcare Products Regulatory Agency regulatory protocol in the U.K.

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