Now the R/S is done I am going to get back in i think. but what do you think about the Phase 2 Extension Study of GCS-100 in Chronic Kidney Disease. Why is there an extension? they will release data in march looks like for the initial phase 2. Do you think the data is good or bad? not sure i completly understand what the extension is for.
Ryan extension is for safety and toleration determination. There are 2 different doses, only active high and lower dose. They are taking patients who finished the 1st trial, some may have been on placebo from the way it reads. I don't know if they know anything about data, but I would think so, or why bother like you said. I would think they could infer some efficacy data (may show some trend) from it to help design a future trial. I am thinking of holding my shares for a while. All JMO, if you all have some other info please add to discussion.
"The Phase 2 Extension study (GCS-100-CS-4003) will enroll CKD patients who completed the 12-week Phase 2 study (GCS-100-CS-4002), including a maximum of 115 patients at 5 sites. Subjects will be randomly assigned 1:1 to treatment with 1.5 mg/m2 GCS-100 or 30 mg/m2 GCS-100. All doses of study drug will be administered intravenously once weekly for up to 8 consecutive weeks with a 4 week follow-up period and then at least once a month for a total of 1 year.
The primary objective of the Phase 2 Extension study is to determine the safety and tolerability of extended dosing with GCS-100. The secondary objective will be to determine the efficacy as measured by eGFR of GCS-100 administered for 8 weeks relative to the effect of 8 weeks of treatment for the same patient on the GCS-100-CS-4002 study including those who were on placebo. This study also provides the opportunity to compare crossover data for individual patients from the initial Phase 2 study and this extension study."
Ryan, there is a good bit of research out there from varying groups that establish the inverse correlation of Galectin-3 and GFR. What isn't well established is if the relationship is causative and not just incidental. Animal studies are tough in this whole Galectin biz, in my view, because there is a good bit of difference in the expression (& probably fxn) across species. There is one rat study from 2012 out there by Yu et al (PHD dissertation), entitled, "Pharmacological Inhibition of Galectin-3 Protects Against Hypertensive Nephropathy". I haven't found anything in humans yet that gives me confidence in the study. I also don't like the number of shares in this company, fully diluted. However, I bought 50k shares with play money before the 50:1 for the throw of the dice. Could get a decent run up prior to results as well.
My outmost concern are the outstanding prefered shares. Although no prefered share holder is allowed to convert preferred shares and to own common shares in excess of 9,99% of common shares, this rule sets no real limit on conversion of prefered. Its allowed to sell all common shares, convert the prefered ones, sell again the resulting common shares, .... and so on.
This problem works like a brake for a sustainable share price appreciation. I didn't a DD on the science of the pipeline drug.