The oral drug, SUBA-Itraconazole, may be an effective treatment for patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), without many of the issues associated with surgery, according to a press release.1
BCCNS, also known as Gorlin Syndrome, causes patients to develop basal cell carcinomas frequently throughout their lifetime. Surgical removal is the standard of care, though this treatment can leave patients with significant scarring.
HedgePath Pharmaceuticals developed SUBA-Itraconazole, which is in phase 2(b) testing, as an alternative to surgery for the treatment of these lesions.
Two interim analyses were conducted: change in the sum of the longest diameters of each tumor per patient (tumor burden), and the change in the longest diameter of target lesions per patient.
Tumor burden has not increased for any patient, and has reduced by more than 30% for 8 of the 13 enrolled patients. Of 167 analyzed lesions, 25% disappeared, 25% were reduced by more than 30%, 42% are stable (defined as less than 20% increase or less than 30% reduction), and 8% increased by more than 20%. No tumors required surgical removal.
No grade 2 or higher toxicities were reported for 90% of enrolled patients.
The developers intend to continue data collection; if the final results are as encouraging as the interim analyses, a New Drug Application will be filed with the U.S. Food and Drug Administration.
- HedgePath Pharmaceuticals announces positive interim data in its phase II(b) cancer trial. PRNewsWire. http://www.prnewswire.com/news-releases/hedgepath-pharmaceuticals-announces-positive-interim-data-in-its-phase-iib-cancer-trial-300308347.html Updated August 3, 2016. Accessed August 4, 2016.