Fennec Pharmaceuticals Inc. (FENC) is expanding the clinical reach of its otoprotective therapy PEDMARK as the University of Arizona Cancer Center launches a new investigator-sponsored Phase I/II study evaluating the drug in adolescent and young adult (AYA) and adult patients receiving Cisplatin chemotherapy.
Cisplatin remains a widely used chemotherapy for solid tumors, but it carries a high risk of permanent hearing loss- a complication that can severely impact communication, learning, and long-term quality of life.
PEDMARK, a sodium thiosulfate formulation, is currently the only FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors. It also holds a Category 2A NCCN recommendation for use in AYA patients.
The new University of Arizona study, led by investigators Lisa Davis and Alejandro Recio-Boiles, will assess intravenous PEDMARK in adults receiving cisplatin for head and neck and testicular cancers.
The Phase I/II trial is designed to evaluate reductions in hearing impairment compared with historical controls and measure the systemic elimination of unbound cisplatin up to six hours after infusion.
The study adds to a growing number of investigator-sponsored efforts evaluating PEDMARK across broader patient populations. Tampa General Hospital began a similar real-world evaluation in March 2026, and City of Hope is currently studying PEDMARK in adult men with metastatic testicular germ cell tumors. Additional investigator-sponsored studies across new tumor types and age groups are under review.
Fennec's Chief Medical Officer, Pierre S. Sayad, said these independent studies reflect growing clinical interest in understanding how PEDMARK may benefit broader patient populations beyond those included in pivotal trials. He added that real-world data from these efforts could help support wider adoption and inform potential future regulatory discussions.
PEDMARK has been validated in two completed Phase 3 trials- COG ACCL0431 and SIOPEL 6- and is commercially available in the U.S., U.K., and Germany (as PEDMARQSI). The therapy also holds Orphan Drug Exclusivity in the U.S. and Pediatric Use Marketing Authorization in Europe.
FENC has traded between $4.68 and $9.92 over the past year. The stock closed Tuesday's trading at $6.32, down 1.56%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.