TMCnet News
Fennec Pharmaceuticals Announces Oral Presentation of Detailed Results from Investigator-Initiated Phase 2 STS-J01 Clinical Study of Pedmark® in Japan at SIOP 2026~ Primary Endpoint Met: American Speech-Language-Hearing Association (ASHA)-Defined Hearing Loss Occurred in 24.0% of Patients Versus the Prespecified Historical Benchmark of 56.4% (P=0.001) ~ ~ 84% of Patients Had Grade 0 Hearing Loss by Brock Criteria; No Grade 3 or Grade 4 Hearing Loss Was Observed ~ ~ Objective Responses Observed in 23 of 24 Evaluable Patients (95.8%); Prospective Pharmacokinetic Analyses Provide New Mechanistic Insight Supporting the Six-Hour PEDMARK® Administration Interval for Pediatric & Adolescent and Young Adult (AYA) Patients ~ ~ Building Upon the Pivotal Children’s Oncology Group (COG) Protocol ACCL0431 & SIOPEL 6 Studies, STS-J01 Represents Third Study to Demonstrate that PEDMARK® Showed No Interference with Cisplatin Antitumor Activity ~ RESEARCH TRIANGLE PARK, N.C., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced the oral presentation of detailed results from the investigator-initiated Phase 2 STS-J01 clinical trial evaluating PEDMARK® (sodium thiosulfate injection) for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult (AYA) patients with non-metastatic solid tumors in Japan. The data will be presented today during the 58th Annual International Society of Pediatric Oncology (SIOP) Annual Meeting in San Antonio, TX. PEDMARK® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A endorsement for use in AYA patients. The study enrolled 33 patients across 11 institutions in Japan, including 27 patients in the primary cohort and six in exploratory cohorts. Key study findings include:
“The clinical and pharmacologic findings of STS-J01 are compelling. We observed a significant reduction in hearing loss, with no Grade 3 or Grade 4 hearing loss by Brock criteria, alongside a 95.8% objective response rate in evaluable patients. The prospective pharmacokinetic analyses further provide important mechanistic insight into why the six-hour interval matters, supporting a model in which PEDMARK® acts on residual circulating and exchangeable platinum after cisplatin has had time to distribute and initiate its antitumor activity. Together, these findings add an important independent body of evidence supporting the clinical rationale for delayed PEDMARK® administration,” said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. The safety profile was consistent with the known tolerability profile of PEDMARK® and the expected toxicities of cisplatin-containing chemotherapy. No serious adverse event was attributed to PEDMARK®, and no Grade 4 PEDMARK®-related toxicity was observed. “For patients navigating cancer in Japan, the ability to successfully treat their tumors while preserving hearing can have a profound impact on their lives long after treatment ends. Cisplatin remains an important and effective treatment, but the risk of permanent hearing loss represents a significant unmet need, particularly for children and young people who may live with its consequences for the rest of their lives,” said Eiso Hiyama, M.D., PhD, lead investigator and professor in the Department of Pediatric Surgery at Hiroshima University Hospital in Hiroshima, Japan. “The results from STS-J01 are encouraging because they demonstrate significant hearing protection and provide reassuring clinical context regarding antitumor activity with delayed PEDMARK® administration. We believe that these results provide further support and confidence in PEDMARK® for healthcare professionals.” Fennec is pursuing registration in Japan and is currently exploring partnering or licensing opportunities for PEDMARK®. About the STS-J01 Study About Cisplatin-Induced Ototoxicity Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy.2 Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.3 Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.4,5 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations. PEDMARK® (sodium thiosulfate injection) Additionally, PEDMARK® is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement. Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.6,7 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.8,9 PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. Indications and Usage Limitations of Use Important Safety Information Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma. PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers. Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L. Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate. The most common adverse reactions (=25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (=25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia. Please see full Prescribing Information for PEDMARK® at: www.PEDMARK.com. About Fennec Pharmaceuticals In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in multiple countries. PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK until 2039 in both the U.S. and internationally. For more information, please visit www.fennecpharma.com and follow on LinkedIn. Forward Looking Statements For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com. PEDMARK® PEDMARQSI® and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc. ©2026 Fennec Pharmaceuticals Inc. All rights reserved. For further information, please contact: Investors: Corporate and Media: 1 Sheth S et al. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Frontiers in Cellular Neuroscience. 2017, Vol. 11. 
|
