RESEARCH TRIANGLE PARK, NC, March 25, 2022 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate ) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced that the company will participate in the Maxim 2022 Virtual Group Growth Conference, taking place March 28-30, 2022. The conference will include company presentations, fireside chats, panel discussions, and live Q&As hosted by Maxim Research analysts.
Robert Andrade, CFO of Fennec, will participate in a fireside chat on Monday, March 28 at 4:00 p.m. ET.
This conference will be live on M-Vest. To see, click here to reserve your place or https://m-vest.com/events/2022-virtual-growth-conference.
Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and especially harmful to survivors of childhood cancer.
In the United States and Europe, it is estimated that more than 10,000 children each year may receive platinum-based chemotherapy. The incidence of ototoxicity depends on the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There are currently no established preventive agents for this hearing loss and only expensive, technically difficult and suboptimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children who experience ototoxicity at critical developmental stages lack speech language development and literacy, and older children and adolescents lack social-emotional development and academic achievement.
PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies for survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. COG protocol ACCL0431 enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 only enrolled patients with hepatoblastoma with localized tumours.
The Marketing Authorization Application (MA) for sodium thiosulfate (trade name PEDMARQSI) is currently being assessed by the European Medicines Agency (EMA). PEDMARK received Breakthrough Therapy and Fast Track designation from the FDA in March 2018.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK™ for the prevention of platinum-induced ototoxicity in pediatric patients. Additionally, PEDMARK has received orphan drug designation in the United States for this potential use. Fennec has a licensing agreement with Oregon Health and Science University (OHSU) for exclusive worldwide licensing rights to intellectual property relating to sodium thiosulfate and its use for chemoprotection, including the prevention of induced ototoxicity by platinum chemotherapy in humans. For more information, visit www.fennecpharma.com
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 these terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the Company’s expectations regarding its interactions and communications with the FDA, including the Company’s expectations and objectives regarding the resolution of the issues raised in the CRL and the Company’s plans to resolve them, as well as the expected timing of the finalization and filing of a new NDA submission for PEDMARK. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to differ, including risks and uncertainties relating to the Company’s dependence on third-party manufacturing, the risk that unforeseen factors may delay the resubmission of NDAs, the risks of delay or failure to obtain FDA approval for PEDMARK, the risks related to the ability of the Company and its manufacturer to adequately respond to concerns identified in the CRL, the risk that the resubmission of the NDA to the FDA will not be satisfactory, that regulatory developments and guidelines may change, data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receive required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability due to an outbreak of a pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, the protection afforded by patents and patent applications of the Company may be challenged, invalidated or circumvented by its competitors, the market available for the products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, the revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future cap needs. 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 fiscal year ended December 31 2021. 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 see our public filings available at www.sec.gov and www.sedar.com.
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Fennec Pharmaceuticals Inc.
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