Basal cell carcinoma nevus syndrome (BCCNS) patients have
new hope for an oral treatment after HedgePath Pharmaceuticals Inc. announced
the interim data on the Phase IIb cancer trial.
HedgePath released the data after 16 weeks of the clinical trial. SUBA-Itraconazole oral capsules produced an average 60 percent tumor reduction in eight of the 13 participants. In addition, 25 percent of the lesions disappeared and 42 percent have stabilized. Twenty-five percent of the lesions have shrank by more than 30 percent.
BCCNS is a rare genetic mutation, with approximately 10,000 diagnosed cases in the U.S. Numerous basal cell carcinomas (BCC) develop and require surgical removal. The disease can lead to facial disfigurement due to multiple surgeries to remove the tumors. The participants in the study had at least 10 surgeries to remove tumors and currently display 10 to 15 significant lesions.
SUBA-Itraconazole qualifies for Orphan Drug Designation due to the rarity of BCCNS. If the final study results are consistent with the interim data, the U.S. Food and Drug Administration may grant the medication a New Drug Application. At this point, the only approved treatment for the tumors is surgery; there are no drug therapies for BCCNS.