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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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February 3, 2016
08:50 EDTRCPIRock Creek Pharmaceuticals reports results of Phase II trial of lead compound
Rock Creek Pharmaceuticals has received an interim report of the pharmacodynamic results of its Phase I clinical trial of its lead compound, anatabine citrate. The previous Phase I trial demonstrated that the drug was safe, well tolerated and had a consistent pharmacokinetic profile. This PD report highlighted that anatabine citrate produced significant reductions in a key marker of inflammation, STAT 3, in human volunteers. In this present study, STAT 3 activity was shown to be significantly reduced in blood samples taken after drug administration compared to blood samples taken before drug administration. This is the first time a drug version of the compound, under strict regulatory conditions, has been shown to be anti-inflammatory in human blood. The company has been unifying its scientific, clinical, regulatory and consultancy resources to focus on inflammatory skin diseases and is planning a Phase IB, proof-of-concept trial with patients diagnosed with mild to moderate psoriasis, expected to commence mid-2016.

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