Speaking of markets, the "Beyond Tamoxifen" paper suggests 3 major breast cancer markets for Targretin. Since Targretin works better than Tamoxifen in the breast cancer model and produces fewer side effects (it actually inhibits the uterine growth stimulating properties of Tamoxifen), one application would be as monotherapy.
Since Targretin also synergizes with Tamoxifen, and second approach would be combination therapy. Tumors frequently become resistant to Tamoxifen and a study of patients who had been on Tamoxifen for more than 5 years found that there was no benefit beyond the five years. Combination treatment with Tamoxifen, or other SERMs such as Evista (Raloxifene), Droloxifene, CP-366,156, or TSE424 would allow the drugs to be used at lower concentrations to minimize side effects and further resistance.
A third application would be to treat patients who did become resistant to Tamoxifen.
Of course all of these trials would take considerable time and money. However, since oral Targretin will likely win approval for CTCL next year (NDA is slated for this year), off label use could be very significant. As shown by LGND's record volume of almost 2 million shares on Thursday, as well as new posters to this site, there is considerable interest in breast cancer treatment (and prevention).
MD's frequently prescribe off-label use for treatment of life threatening conditions, especially if some efficacy has already been demonstrated in Phase II trials.
It sounds like LGND is considering Phase II trials for all of the above. CEO Robinson has recently said that the breast cancer data keeps getting better and better and LGND will aggressively pursue clinical trials targeting advanced breast cancer.
Looks like it's going to be a very good year. |
