What the hell is this?? From gov't site "clinicaltrials". On July 7 the site shgowed the FDA approved and they are RECRUITING for patients with <<severe dry eye>>. The trial is being done by Dr. David Dunn. This is NOT the dry eye trial to start in August with ORA Inc! This is a different one. BUT????? RGRX already STARTEd the dry eye trial with Dr. Dunn..on December 22, 2010. That was for regular Dry Eye from GVHD. THIS trial is for "severe" dry eye with GVHD. Each trial is 20 patients. read for your self! It is just fresh on clinical trials:
I want to know WHY this trial hits the site in July? For severe dry eye?? Because in December 2010, RGRX said this:
<<20-Patient Trial Expected to be Completed in 2011 ROCKVILLE, Md., Dec 22, 2010
RegeneRx Biopharmaceuticals announced today that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the Company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease. The double-blind, placebo-controlled, investigator-sponsored trial is expected to enroll a total of 20 patients over the next several months, with data reported later in 2011. The clinical trial is being conducted under a physician-sponsored IND in Detroit, Michigan. Steven Dunn, M.D., the principal investigator in this study, is an ophthalmologist and corneal specialist who previously treated a group of patients with recalcitrant neurotrophic keratitis with RGN-259. In a group of six such patients, Dr. Dunn reported substantial healing within the treatment period or follow-up.>>
The reasson I ask? if Dr. Dunn finished the December 2010 announced trial? In regular GVHD with dry eye? Why would he then move to do a SEVERE dry eye trial, with all FDA notifications - in JULY 2011.....if the first one of Dec 2010 did NOT GO WELL??? if it did not go well, why move up to severe dry eye?
Is this a hint that the first Dr. Dunn trial was a winner? Or is the FDA mentioned trial just the original 2010 one???
RGRX, as USUAL.....won't straighten us out. But if this JULY 2011 trial is a NEW one? I think it;s a sign the 2010 one went well!
......Michigan (Drs Dunn, Heidemann, and Chow); RegeneRx Biopharmaceuticals, Inc, Bethesda, Maryland...thymosin beta 4 eye drops supplied by RegeneRx Biopharmaceuticals, Inc (Rockville, Maryland...unpaid member of the advisory committee of RegeneRx; Mr Crockford, Drs Turjman and Allan......
Where else could they find thymosin beta 4 eye drops besides Regenerx?
<<Study First Received: July 7, 2011 Last Updated: July 12, 2011>>
...but then goes on to state:
<<Estimated Enrollment: 20 Study Start Date: March 2011 Estimated Study Completion Date: December 2012 Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)>>
Dates referenced are a bit all over the map. BUT...still encouraging.
Results & patents. Nothing else much helps until we get both these.
See for yourself. Here is clinicaltrials site. Look for trial #5, which is the soon phs 2 by ORA Inc in dry eye. Then look at trial no#7.....which is in "severe" dry eye. The FDA put this up in early July:
I wish I knew what the "severe" dry eye trial is. Is it just the dry eye trial that was started with patients in December 2010? but that trial was just dry eye. The FDA is very specific in this new trial that it is only for "severe dry eye".
Is the dry eye trial started Dec 2010 about done? Was that only in moderate dry eye? was there success in it? Is that why they go to FDA to file and start another one in "severe dry eye"? If this the case? why isn't RGRX releasing results of moderate dry eye started Dec 2010?
Too many things are NOT made CLEAR to shareholders. RGRX mgmt knows, but they don't inform shareholders at all.
And BTW? I am STILl dying to know just what the granted 2007 patent in USA for TB 4 covers. According to the issued patent, RGRX filed for EVERYTHING...the kitchen sink. But why won't RGRX tell us what we have or don't have???
shareholders deserve to be better informed. I find the stuff...but I can't say what it means for sure.