Specialty pharmaceuticals firm Fennec Pharmaceuticals Inc. (FENC:NASDAQ), which is focused on improving the lives of children with cancer who experience hearing loss due to chemotherapy treatment, today announced that "the U.S. Food and Drug Administration (FDA) has approved PEDMARK® (sodium thiosulfate injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors."
David R. Freyer, D.O., M.S. remarked, "Historically, there have been no approved treatments for preventing cisplatin-induced hearing loss. The FDA approval of PEDMARK addresses an enormous unmet need and for many children and young adults has the potential to greatly improve everyday activities for these patients."
The company noted that PEDMARK is now the only FDA-approved treatment indicated for reducing the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors who are one month of age and older.
Fennec Pharmaceuticals' CEO Rosty Raykov commented, "The FDA approval of PEDMARK represents an important breakthrough for pediatric patients with localized, non-metastatic solid tumors at risk for cisplatin-induced hearing loss. Cisplatin is a critical standard of care agent used in the treatment of pediatric cancers; however, even though effective, it could be harmful to children, frequently causing permanent and irreversible bilateral hearing loss. With PEDMARK, physicians now have an approved treatment option to reduce the risk of cisplatin-induced hearing loss in pediatric patients."
The firm advised that the FDA approved PEDMARK based on the results from two separate Phase 3 studies. The trials were designed to measure the safety and efficacy of PEDMARK in combination with a cisplatin-based regimen compared to stand-alone cisplatin-based regimens for the reduction of cisplatin-induced hearing loss in pediatric patients.
The company reported that in each of these clinical studies, the PEDMARK plus cisplatin arms showed consistently and significantly lower incidences of hearing loss compared to the cisplatin arm alone. The firm stated that in the Phase 3 COG ACCLO431 trial, 21.4% of subjects in the PEDMARK plus cisplatin cohorts experienced hearing loss versus 73.3% in the cisplatin alone arm.
Similarly, in the Phase 3 SIOPEL6 trial, 32.7% of participants in the PEDMARK plus cisplatin cohorts experienced hearing loss versus 63.0% in the cisplatin alone arm.
David R. Freyer, D.O., M.S., Director of the Survivorship & Supportive Care Program at the Cancer and Blood Disease Institute at Children's Hospital in Los Angeles, who served as the primary investigator in the Phase 3 COG ACCL0431 study, remarked, "Historically, there have been no approved treatments for preventing cisplatin-induced hearing loss. As a physician focused on pediatric cancer for many years and a primary investigator in the pivotal PEDMARK Phase 3 Clinical Oncology Group (COG) trial, the FDA approval of PEDMARK addresses an enormous unmet need and for many children and young adults has the potential to greatly improve everyday activities for these patients."
The company mentioned that even though treatments and outcomes for pediatric patients with localized, solid tumors have improved greatly, the use of platinum-based chemotherapy, which remains the accepted standard of care in many cases, can prove to be toxic to the ears with cisplatin treatment often causing permanent bilateral hearing loss in 60-90% of children treated with cisplatin.
The company explained that chemotherapeutic agents such as Cisplatin and other platinum-based compounds are essential in treating pediatric malignancies. However, these platinum-based therapies may cause permanent and irreversible hearing loss (ototoxicity) depending on the duration of treatment and dosage levels.
Fennec is a specialty pharmaceutical firm headquartered in Research Triangle Park, N.C. The company is dedicated to improving the lives of children with cancer and primarily focuses on developing and commercializing PEDMARK® for use in preventing platinum-induced ototoxicity in pediatric patients.
Fennec began the day with a market cap of around $194.23 million with approximately 26.07 million shares outstanding. FENC opened nearly 3% higher today at $7.85 (+$0.22, +2.88%) over yesterday's $7.63 closing price. The stock traded today between $7.65 and $8.75 per share and is currently trading at $8.69 (+$1.06, +13.89%).
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