Fennec Pharmaceuticals Inc. (NASDAQ: FENC) eked out gains Tuesday after the company disclosed that it has received Breakthrough Therapy designation by the FDA for PEDMARK.
PEDMARK, a unique formulation of sodium thiosulfate, is touted as a Breakthrough Therapy designation for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).
Fennec CEO Rosty Raykov said in a statement Tuesday, "The decision by the FDA to grant PEDMARK the first Breakthrough Therapy designation for the prevention of cisplatin ototoxicity reflects a recognition of the promising efficacy and safety data generated from SIOPEL 6 and COG ACCL0431 studies.
"We believe the recent receipt of Fast Track designation, and today, Breakthrough Therapy designation highlights the current lack of safe and effective treatments and overwhelming need to address this serious condition."
According to the FDA, Breakthrough Therapy designation is given when preliminary clinical evidence has been provided to show that a treatment effect may represent substantial improvement over available therapies for the treatment of a serious condition.
The designation includes all of the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program.
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.
The North Carolina-based Fennec saw its stock gain two cents late Tuesday morning to $10.92.
