The method of action on THLD's drug is completely different from CYTR's. Both drugs, if approved, will ne synergistic in treating STS. In addition, THLD will be reporting out at the end of this year, not next year. Finally, THLD has a partner with Merck of Germany who is paying 75 percent of the trials so they are not burning cash as quickly as CYTR. I am long both stocks. Review the presentations by THLD as they clearly explain the two different methods of action.
Well, I can't get the entire excerpt to post. But age 50 is a significant threshold where patients have an inferior survival outcome and that could explain the differences between OS and PFS between the two trials.
For some reason, all of the excerpt did not post. Here is the conclusion to the 2011 study.
Rhabdomyosarcoma was the only entity with a median age
I believe the age difference is a material difference between the two trials.
Below are the results from a retrospective study.
There were 48,012 cases that met the selection criteria. Individuals less than 20 years of age represented 5.6%, with rhabdomyosarcoma being the most common subtype. In adults, the most common types were Kaposi sarcoma, fibrohistiocytic tumors, and leiomyosarcoma. Rhabdomyosarcoma was the only entity with a median age
Is this statistically relevant? There are no statistics that are applicable. What can be said tis that spontaneous remission is extremely rare, by some estimates from one in 60,000 to one in 100,000. It should be noted that these are patients in this phase two trial who already failed treatment. So to have three of eighteen patients with a pathologically verified complete response seems to suggest a positive outcome. In other words, something is going on here that is not mere chance.
I give the STS trial a higher percentage of success because it includes maintenance therapy. There was no maintenance therapy in the Picasso trial. THLD reported updated data on November 15 2012. I believe the maintenance therapy is a data point that is mostly ignored when making comparisons to the Picasso trial.
Review the PDF shareholder file on the THLD website:
TH‐CR‐406:TH‐302 Phase 3 Trial in Patients with Soft Tissue Sarcoma
You will see that the "recent historical data" refers to EORTC 92012 on page 3.
The Picasso trial had nothing to do with the expanded patient enrollment. Rather it was the EORTC 62012 trial which resulted in the expanded enrollment. One must remember that in the EORTC trial, patient enrollment was limited to those sixty years and younger. So this was a younger population which, perhaps, could explain, in part, the improved overall survival.