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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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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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