Notes on PYMX call
1. Earlier studies of PMX-60056 by itself (I assume Phase 1a) showed that the higher the dose of the drug, the lower the blood pressure. That was in a trial without the use of heparin. As the drug is only supposed to be used in the presence of heparin, the drug was tested in conjunction with heparin in the Phase 1b and there were no significant changes in blood pressure.
2. The Phase 1b trial was conducted in the U.S. with a total of 6 patients at a total cost of just $100,000. There were 2 dosing groups of 3 patients each and each patient served as their own control by receiving heparin then receiving either placebo or PMX-60056, going through a two-day washout period, and then repeating the procedure with the other control.
3. There were no SAEs in the Phase 1b. The main side effect was a "warmth" and "itching" that occurred during the 10-minute infusion of PMX-60056 but quickly went away after the end of the infusion.
4. Size of market - With respect to heparin, there are 8 million unit doses of protamine sold each year. With respect to LMWH (where protamine is useless), there are about 12 million patients that receive a LMWH each year. Of these, 1-4% experience serious bleeding and up to 20% experience clinically significant bleeding.
5. PYMX expects to start Phase 1b/Phase 2 studies of PMX-60056 in LMWH and heparin patients early in 2010 and to complete such studies in 1H2010.
6. No chatter on potential partners or anything.
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