TD, There are really three different Targretin results slated for this year. I assume that you are asking about the breast cancer data, but I would not be surprised to see some coordination of the release of results.
The hardest date is the FDA's decision of Targretin for CTCL. Since it received priority review, the FDA must do something by Christmas. Usually a six month deadline usually translates into some very close to six months, so I suspect that the decision will be in late December.
The breast cancer trails is open label, and I'm fairly certain that LGND has looked at the very early data. The could release a small amount of data this quarter. The trial is fairly complex, two concentrations targeting 3 populations of advanced breast cancer, so the total number of patients in each arm is fairly small and there are at least 29 participating institutions, so a good chunk of data could be available by the end of the year, and a small chunk should be available now.
LGND has also promised an update on the psoriasis data being generated in Europe. The initial data was quite encouraging, and was released early, so the breast cancer data could follow suit.
I suspect that the percentage of patients responding will be significantly below the 94% generated for rats. However, Targretin will be quite expensive and a response rate as low as 10% would still create quite an improvement to LGND's bottom line.
If LGND releases breast cancer data this Q, I would expect the numbers to be pretty small. However, a few positives could create quite a stir because the disease is extremely high profile and the treatment is oral, so patients with advanced breast cancer would likely create a significant demand, and if approved for CTCL, off label use would soar. |
