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July 11, 2014
16:34 EDTRCPIRock Creek Pharmaceuticals provides update on U.S. investigational NDA
Rock Creek Pharmaceuticals announced that the FDA has notified the company that the agency will provide comments on RCP's Investigational New Drug application before granting the company permission to start its clinical trial in the US. Dr. Chris Chapman, RCP's President, commented, "We appreciate the agency's review and comments on our IND. When we receive the agency's official comments and/or recommendations, we will respond expeditiously. We look forward to moving this important product through the regulatory process."
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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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