Fennec Pharmaceuticals Receives Fast Track Designation by FDA for PEDMARK
March 21 2018 - 5:30AM
Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX), a specialty
pharmaceutical company, today announced that the U.S. Food and Drug
Administration (FDA) has granted PEDMARK (a unique formulation of
sodium thiosulfate) Fast Track designation for prevention of
cisplatin-related ototoxicity in pediatric patients with standard
risk hepatoblastoma (SR-HB). There are currently no drugs approved
in the US for this condition. Fast Track designation is
intended to facilitate development and expedite review of drugs to
treat serious and life-threatening conditions so that an approved
product can reach the market expeditiously.
"We believe the receipt of Fast Track
designation from the FDA highlights the serious nature of hearing
loss that patients have following cisplatin chemotherapy and the
current lack of safe and effective treatments," said Rosty Raykov,
President and Chief Executive Officer of Fennec. "We look forward
to the more frequent interactions with the Agency that the Fast
Track designation provides, as we prepare for the NDA filing.”
Fast Track designation allows for closer
collaboration with the review team within the Oncology Division at
FDA, with the goal of getting important new drugs to patients more
rapidly. Through the Fast Track program, a product may be eligible
for priority review at the time of a New Drug Application (NDA)
filing and may also be eligible to submit completed sections of the
NDA on a rolling basis, before the complete application is
submitted.
About PEDMARK™ (Sodium Thiosulfate
(STS))
Cisplatin and other platinum compounds are
essential chemotherapeutic components for many pediatric
malignancies. Unfortunately, platinum-based therapies cause
ototoxicity in many patients, and are particularly harmful to the
survivors of pediatric cancer.
In the U.S. and Europe there is
estimated that over 10,000 children may receive platinum based
chemotherapy. The incidence of hearing loss in these children
depends upon the dose and duration of chemotherapy, and many of
these children require lifelong hearing aids. There is currently no
established preventive agent for this hearing loss and only
expensive, technically difficult and sub-optimal cochlear (inner
ear) implants have been shown to provide some benefit. Infants and
young children at critical stages of development lack speech
language development and literacy, and older children and
adolescents lack social-emotional development and educational
achievement.
STS has been studied by cooperative groups in
two Phase 3 clinical studies of survival and reduction of
ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and
SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol
enrolled one of five 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
enrolled only hepatoblastoma patients with localized tumors.
About Fennec
Pharmaceuticals
Fennec Pharmaceuticals, Inc., is a specialty
pharmaceutical company focused on the development of Sodium
Thiosulfate (STS) for the prevention of platinum-induced
ototoxicity in pediatric patients. STS has received Orphan Drug
Designation in the US in this setting. For more information, please
visit www.fennecpharma.com.
For further information, please
contact:
Rosty RaykovChief Executive OfficerFennec
Pharmaceuticals Inc.T: (919) 636-5144
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