Amongst pediatric in addition to adolescent and younger grownup (AYA) sufferers with non-metastatic strong tumors in Japan, optimistic topline outcomes from a part 2/3 medical trial have proven that Pedmark (sodium thiosulfate injection) is related to a discount in chemotherapy-induced ear injury.
The event was introduced in a information launch issued by Fennec Prescription drugs Inc., a specialty pharmaceutical firm, which famous that Pedmark is the primary and so far solely remedy accredited by the U.S. Meals and Drug Administration (FDA) for the discount of the chance of ototoxicity related to cisplatin therapy in pediatric sufferers age 1 month and older with localized, non-metastatic, bought tumors.
The STS-J01 examine enrolled 27 sufferers in its main cohort, age 3 to 18 years, and 6 in exploratory cohorts. The examine’s main endpoint was met, with information exhibiting that 24% and 16% of evaluable sufferers handled with Pedmark skilled listening to loss as assessed by the American Speech-Language-Listening to Affiliation (ASHA) standards and Brock grade scaling, respectively. Within the cisplatin-only arms of Pedmark’s pivotal part 3 trials, 56% of sufferers developed clinically important listening to loss in response to ASHA standards and 63% developed listening to impairment beneath Brock grade scoring. In line with the information launch, the examine additionally demonstrated that among the many largest subgroup of sufferers, age 7 to 18 years, listening to loss solely occurred in 19% and 14.3% in response to the ASHA and Brock scores, respectively.
Evaluation exhibiting an total tumor response fee of 95% confirmed that Pedmark didn’t intervene with cisplatin’s antitumor exercise, the corporate said.
“The STS‑J01 findings add compelling assist to the worldwide medical proof base for PEDMARK®,” mentioned Pierre S. Sayad, chief medical officer of Fennec Prescription drugs, in an announcement included within the information launch. “Seeing such low charges of listening to loss in an actual‑world, investigator‑initiated setting in Japan reinforces the consistency and magnitude of Pedmark’s protecting impact, which has now been demonstrated throughout a number of continents, tumor varieties and medical settings. Importantly, the excessive tumor response fee and the pharmacokinetic information present that Pedmark doesn’t intervene with how cisplatin works; by six hours, the lively platinum is already sure and inactive. It is a crucial and extremely reassuring discovering for physicians, households and regulators alike.”
The information launch moreover famous that in additional than 200 treatment-emergent negative effects, none have been discovered to be attributable to Pedmark.
“For many years in Japan, we have now witnessed the profound and lifelong burden of cisplatin‑induced listening to loss among the many youngsters and younger adults,” mentioned Dr. Eiso Hiyama, lead investigator and professor within the Division of Pediatric Surgical procedure at Hiroshima College Hospital in Hiroshima, Japan. “These encouraging outcomes from the primary large-scale pediatric and adolescent and younger adults trial in Japan show that Pedmark can defend listening to with out compromising cisplatin’s efficacy or introducing any regarding negative effects. As a clinician, and with the present unmet medical want of most cancers sufferers in Japan, these findings give me confidence within the effectiveness and security of Pedmark which can provide sufferers the possibility for each survival and preserved high quality of life.”
In line with the information launch, full outcomes from the examine shall be shared in a future scientific presentation and submitted for publication in a peer-reviewed journal.
The examine, in response to the information launch, enrolled sufferers throughout two cohorts, with 27 youngsters age 3 to 18 years and 6 infants from age 1 month to lower than 3 years, all with localized strong tumors, together with neuroblastoma, hepatoblastoma, germ cell tumors, bone and delicate tissue sarcomas, medulloblastoma and atypical teratoid rhabdoid tumors. Sufferers, the information launch defined, obtained Pedmark intravenously six hours after cisplatin infusion, with dosing adjusted by physique weight.
Reference
- “Fennec Prescription drugs Declares Optimistic Topline Outcomes From Investigator-Initiated Scientific Research of PEDMARK® in Japan to Cut back Cisplatin-Induced Listening to Loss,” information launch; https://www.globenewswire.com/news-release/2025/12/02/3197763/0/en/Fennec-Prescription drugs-Declares-Optimistic-Topline-Outcomes-From-Investigator-Initiated-Scientific-Research-of-PEDMARK-in-Japan-to-Cut back-Cisplatin-Induced-Listening to-Loss.html
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