Fennec Pharmaceuticals Announces Investigator-Sponsored Study to Be Conducted by University of Arizona Cancer Center
Rhea-AI Summary
Fennec Pharmaceuticals (NASDAQ:FENC) announced the University of Arizona Cancer Center will conduct an investigator-sponsored Phase I/II study evaluating PEDMARK® (sodium thiosulfate) as an otoprotectant in adolescent/young adult and adult patients with head and neck and testicular cancers receiving cisplatin.
The release notes PEDMARK® is approved for pediatric patients one month and older and holds a NCCN 2A recommendation for AYA patients. Fennec cited two other recent institution-led studies at Tampa General Hospital and City of Hope; additional investigator-initiated studies are under review.
AI-generated analysis. Not financial advice.
Positive
- PEDMARK approved for pediatric patients (one month+)
- NCCN 2A recommendation for AYA patients
- Multiple investigator-initiated studies started at major centers (Arizona, Tampa, City of Hope)
Negative
- No adult FDA label expansion announced; adult indication remains unapproved
- University-led Phase I/II trial indicates early-stage evidence; definitive adult efficacy not yet established
News Market Reaction – FENC
On the day this news was published, FENC declined 1.56%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peer moves were mixed, with IMMP down ~2.6% and LXEO up ~3.2%. Other close peers like VNDA, AVIR, CADL, and NMRA showed both positive and negative moves, indicating stock-specific rather than broad biotech momentum for this news.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 31 | Inducement option grants | Neutral | +6.6% | New employee stock options granted under 2026 Equity Inducement Plan. |
| Mar 24 | FY2025 earnings update | Positive | -19.2% | Strong net product sales growth and debt elimination alongside FY2025 net loss. |
| Mar 18 | Earnings date notice | Neutral | -3.7% | Announcement of timing and access details for FY2025 results call. |
| Mar 16 | Patent litigation settlement | Positive | +5.0% | Cipla agrees not to launch generic sodium thiosulfate product before 2033. |
| Mar 04 | Clinical collaboration | Positive | +2.5% | Collaboration with TGH to study real-world PEDMARK use in AYA and adults. |
Recent news with clearly positive fundamentals (earnings growth, collaborations, IP settlement) has usually seen aligned positive reactions, with one notable earnings-related selloff despite strong growth metrics.
Over the last month, Fennec has reported several milestones. On March 4, it settled PEDMARK patent litigation with Cipla, limiting generic entry until September 1, 2033. A March 16 collaboration with Tampa General Hospital expanded real‑world PEDMARK data in AYA and adult patients. The company then flagged its earnings date on March 24, followed by FY2025 results highlighting strong net product sales growth and a debt-free balance sheet. On March 31, inducement option grants were announced. Today’s investigator‑sponsored study further extends real‑world and label‑expansion efforts.
Market Pulse Summary
This announcement expands real‑world evaluation of PEDMARK into AYA and adult patients with head and neck and testicular cancers, complementing recent institution-led studies at Tampa General Hospital and City of Hope. The University of Arizona Phase I/II trial focuses on cisplatin-induced hearing loss and cisplatin elimination over 6 hours. Combined with prior collaborations and the Cipla settlement extending protection to 2033, the news highlights Fennec’s push toward broader clinical adoption and potential label expansion pathways for PEDMARK.
Key Terms
cisplatin medical
ototoxicity medical
hazard ratio medical
intravenous medical
sodium thiosulfate medical
open-label medical
unbound cisplatin medical
pivotal trials medical
AI-generated analysis. Not financial advice.
~ University of Arizona Cancer Center Initiating Study to Explore Use of PEDMARK® in AYA & Adult Patients with Solid Tumors Receiving Cisplatin ~
~ This New Study and Other Independent, Institution-Led Research Continues to Expand Real-World Validation of PEDMARK® Across New Tumor Types and Patient Populations ~
RESEARCH TRIANGLE PARK, N.C., April 07, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced the initiation of an investigator-sponsored study by University of Arizona Cancer Center to evaluate use of PEDMARK® (sodium thiosulfate injection) in adolescent and young adult (AYA) and adult patients with head and neck and testicular cancers receiving cisplatin.
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 adolescent and young adult patients.
Fennec recently announced the initiation of two other institution-led clinical studies:
- In March 2026, Fennec announced that Tampa General Hospital (TGH) Cancer Institute is initiating a study evaluating the real-world clinical utility of PEDMARK® in reducing the risk of ototoxicity in AYA and adult cancer patients receiving cisplatin-based treatment. Additional investigator-initiated studies supporting the use of PEDMARK® in additional tumor types and patient populations, including AYA cancer, have been submitted to Fennec and are currently under review.
- In December 2025, Fennec announced that City of Hope, a U.S. cancer research and treatment organization, is evaluating PEDMARK® for the prevention of cisplatin-induced ototoxicity (CIO) in adult men with stage II-III metastatic testicular germ cell tumors.
Additional investigator-initiated studies supporting the use of PEDMARK® have been submitted to Fennec and are currently under review.
“At Fennec, we are committed to supporting independent research efforts, which help build real-world evidence and expand understanding of how PEDMARK® may benefit patients beyond the populations studied in our pivotal trials,” said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. “Within the last few months, we have announced the initiation of three new studies with leading and highly respected academic and community oncology centers. We believe that data and insights generated through these studies – and others to come – will help support broader clinical adoption of PEDMARK® to prevent ototoxicity, or permanent hearing loss, in AYA and adult cancer patients receiving cisplatin-based treatment. We look forward to continued dialogue with regulatory authorities regarding the potential pathways for PEDMARK® label expansion as our growing body of evidence-based data matures.”
University of Arizona Study Details:
University of Arizona Cancer Center: Tucson, Arizona
Principal Investigator: Lisa Davis / Alejandro Recio-Boiles
| Title: | Phase I/II Open-Label Trial of Intravenous Sodium Thiosulfate (PEDMARK®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy |
| Overview: | Phase I/II study to determine the efficacy of intravenous sodium thiosulfate to reduce hearing impairment caused by cisplatin as determined from prior hazard ratio (HR) risk reduction compared to historical control data and determine the systemic elimination of unbound cisplatin up to 6 hours after infusion. |
About Cisplatin-Induced Ototoxicity
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.1
Hearing loss from cisplatin treatment is not rare. Studies show that between 60
PEDMARK® (sodium thiosulfate injection)
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. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.
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
PEDMARK® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
Important Safety Information
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.
Hypersensitivity reactions occurred in
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
Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.
Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.
The most common adverse reactions (≥
Please see full Prescribing Information for PEDMARK® at: www.PEDMARK.com.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI.
In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, with rights to commercialize PEDMARQSI® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in the U.K. and Germany.
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.
For more information, please visit www.fennecpharma.com and follow on LinkedIn.
Forward Looking Statements
Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®/PEDMARQSI®, the market opportunity for and market impact of PEDMARK®/ PEDMARQSI®, its potential impact on patients and anticipated benefits associated with its use, future commercial and regulatory milestone and royalty payments from Norgine, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2025. Fennec disclaims any obligation to update these forward-looking statements except as required by law.
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:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299
Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com
_______________
1 Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369.
2 Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Trends Pharmacol Sci. 2013;34(8):458-469
3 Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
4 Clemens E, van den Heuvel-Eibrink MM, Mulder RL, et al. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019;20(1):e29-e41
5 . Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.
6 Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
7 Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63-74.
8 Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer. Int J Pediatr Otorhinolaryngol. 2020;138:110401. doi:10.1016/j.ijporl.2020.110401
9 Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.
