Fennec Pharma Backs Real-World Study Of PEDMARK To Protect Hearing In Cancer Patients

Benzinga Newsdesk 8 months ago

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Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company, today announced that the Tampa General Hospital (TGH) Cancer Institute is initiating a study evaluating the real-world clinical

Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company, today announced that the Tampa General Hospital (TGH) Cancer Institute is initiating a study evaluating the real-world clinical utility of sodium thiosulfate injection (PEDMARK®) in reducing the risk of ototoxicity in Adolescent and Young Adult (AYA) and adult cancer patients receiving cisplatin-based treatment.

"The TGH Cancer Institute, in collaboration with the USF Health Morsani College of Medicine, is committed to better understanding and advancing otoprotective strategies aimed at preserving auditory function in patients receiving cisplatin chemotherapy," said Gene A. Wetzstein, PharmD, BCOP, Director of Supportive Care Research & Scientific Affairs at the TGH Cancer Institute and principal investigator of the initiative. "This evaluation will examine real-world clinical data and audiology monitoring that will help inform future clinical research and quality efforts in assessing, preventing and managing ototoxicity."

PEDMARK® is currently approved for pediatric patients one month of age and older with localized non-metastatic solid tumors and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in AYA patients.

"Real-world evidence plays a critical role in demonstrating the clinical utility of PEDMARK® across diverse patient populations and tumor types," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "As more institutions generate data on its use outside of controlled trials, clinicians will gain a clearer picture of the important role of PEDMARK® in providing hearing loss protection for patients receiving cisplatin."

The following sections provide general background information and labeling approved by the U.S. Food and Drug Administration for PEDMARK® and are not intended to solicit participation in any research activity.
 

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