Fennec Pharmaceuticals Inc. (NASDAQ:FENC) on Tuesday shared topline results from the investigator-initiated Phase 2/3 STS-J01 trial of Pedmark (sodium thiosulfate injection) to reduce cisplatin-induced ototoxicity in pediatric and adolescent and young adult patients with non-metastatic solid tumors in Japan.
Pedmark is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity (hearing loss) associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors.
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors.
The study, which enrolled 27 patients in the primary cohort (patients aged 3-18 years) and 6 in exploratory cohorts and examined the addition of Pedmark administered six hours after cisplatin.
The primary endpoint of the study was met, and the data showed that 24% and 16% of evaluable patients who were treated with Pedmark experienced hearing loss (ototoxicity) as assessed by the American Speech-Language-Hearing Association criteria and Brock grade scaling, respectively.
These rates compare favorably to the cisplatin-only arms of Pedmark’s pivotal Phase 3 trials, where 56% of children developed clinically significant hearing loss, and 63% developed hearing impairment.
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Further, the study demonstrated that among the largest subgroup of patients aged 7–18 years, hearing loss occurred in only 19% (ASHA) and 14.3%.
Additionally, pharmacokinetic analyses demonstrated no reduction in cisplatin exposure, and there was no evidence of adverse interaction or attenuation of antitumor activity.
The overall tumor response rate of approximately 95% confirms that Pedmark does not interfere with the antitumor activity of cisplatin.
Pedmark was well-tolerated in the study. Across more than 200 treatment-emergent adverse events reported, none were attributed to Pedmark.
Fennec intends to pursue registration in Japan and will also explore partnering or licensing opportunities for Pedmark. Full results from the study will be shared in a future scientific presentation and submitted for publication in a peer-reviewed journal.
FENC Price Action: Fennec Pharmaceuticals shares were down 0.78% at $7.85 at the time of publication on Tuesday, according to Benzinga Pro data.
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