Fennec Announces City of Hope PEDMARK Trial for Adult Testicular Cancer Patients

Fennec Pharmaceuticals announced that City of Hope will begin an investigator-sponsored Phase I study evaluating PEDMARK, a sodium thiosulfate formulation, to help reduce cisplatin-related hearing loss in adult men with stage II and III metastatic testicular germ cell tumors. Cisplatin has been lifesaving for many, but it can leave a large number of survivors with permanent hearing damage. This study will explore whether adding PEDMARK to standard cisplatin treatment can help protect hearing for men with testicular cancer.

City of Hope principal investigator Dr. Alexander Chehrazi-Raffle noted the importance of addressing long-term quality-of-life issues for survivors, especially since treatment-related hearing loss often lasts a lifetime. Fennec’s chief medical officer, Dr. Pierre Sayad, shared that this study reflects growing interest in focusing on both survival and survivorship in cancer care. PEDMARK is already approved for pediatric and AYA patients with localized, non-metastatic tumors, and expanding research into metastatic disease may provide valuable insight for a population where cisplatin is widely used.

The trial, titled Testing the Addition of PEDMARK to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage, will take place at City of Hope in Duarte, California. Several other investigator-initiated studies involving PEDMARK have been submitted to Fennec and are in various stages of review, signaling continued interest across the oncology community.

Cisplatin-induced ototoxicity remains a serious concern for survivors, often requiring hearing aids or cochlear implants and affecting speech, learning, social development, and overall quality of life. PEDMARK is currently the only FDA-approved therapy proven to reduce the risk of cisplatin-related hearing loss in pediatric patients, based on two Phase 3 clinical trials. Fennec continues to expand access to the therapy in the United States and internationally under the brand name PEDMARQSI, supported by partnerships and regulatory protections that extend through 2039.