Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[bhp1rtp]

SPECIFICALLY MEASURING THE IMPACT OF THE DRUG ON INFLAMMATORY PROCESSES

IMO

This is no ordinary Phase 1 clinical trial.

This sounds like a phase 1 clinical trial combined with a small phase 2 and a small part of a phase 3 clinical trials. Look at what Wikipedia has on Clinical Trials.

Phase 1 Determines whether drug is safe to check for efficacy

Phase 2 Determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever

Phase 3 Determines a drug's therapeutic effect

If RCPI is testing the impact of the drug on inflammatory processes are they not determining a drugs therapeutic effect on inflammation?

http://en.wikipedia.org/wiki/Phases_of_clinical_research

RCPI says they will measure secondary outcomes including standard pharmacokinetics (PK) parameters and also pharmacodynamic (PD) assessment, SPECIFICALLY MEASURING THE IMPACT OF THE DRUG ON INFLAMMATORY PROCESSES.

http://investors.rockcreekpharmaceuticals.com/2015-01-30-Rock-Creek-Pharmaceuticals-Receives-Clinical-Trial-Application-Approval

To understand how big this is look at what the Merk Manual and Wikipedeia have to say about pharmacokinetics (PK) and pharmacodynamic (PD)

Pharmacokinetics (PK) What The Body Does To A Drug

http://www.merckmanuals.com/professional/clinical_pharmacology/pharmacokinetics/overview_of_pharmacokinetics.html

http://en.wikipedia.org/wiki/Pharmacokinetics

Pharmacodynamic (PD) What A Drug Does To The Body

http://www.merckmanuals.com/professional/clinical_pharmacology/pharmacodynamics/overview_of_pharmacodynamics.html

http://en.wikipedia.org/wiki/Pharmacodynamics

They will test six different formulations, 5 of which have modified release profiles and are of different doses.

IMO this means they are testing 5 different modified release profiles of different doses and their original formula. This is a slam dunk on the original formula the only question is how the time release formulas work.