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Fennec Pharma Taking the Lead in Reducing Pediatric Chemo Hearing Loss

By Mindy Hamlin, NCBiotech Writer

Fennec Pharmaceuticals, a specialty pharmaceutical company with executive headquarters in the Research Triangle Park, is making a difference for children with hearing loss.

The company develops PedMark, a formulation of sodium thiosulfate (STS), for the prevention of platinum-induced chemotherapy toxicity in pediatric patients. Cisplatin, a widely used platinum-based chemotherapy agent, can cause irreversible and permanent hearing loss in children as the result of ototoxicity.

This year, the company completed the second of two trials that now pave the way for regulatory approval.

“Our goal is to allow patients and their families to receive PedMark in 2019 and improve their quality of life,” said Fennec CFO Robert Andrade.

Identifying a need for pediatric cancer patients

According to Fennec, each year more than 7,000 children are diagnosed with cancerous tumors that are often treated with platinum-based chemotherapy. The good news: the survival rate for treatment of these tumors exceeds 80 percent. Therefore, a focus on the quality of life after cancer treatment is a big concern.

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While platinum-based chemotherapy treatment is effective, the incidence of high-frequency hearing loss related to ototoxicity in pediatric patients exceeds 60 percent. Hearing difficulties in children can impact language, speech and literacy, as well as social and educational development.

Currently, there is no preventive agent for ototoxicity in development or commercially available. Fennec’s drug has received orphan drug designation, which means it is intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S.

Preventing hearing loss in pediatric patients

Two Phase 3 studies evaluated the reduction of ototoxicity and impact on survival. Preliminary results in the European randomized study, SIOPEL 6, showed that the addition of STS reduced the incidence of cisplatin-induced hearing loss. SIOPEL is the international society for pediatric oncology.

The numbers in the SIOPEL 6 study speak for themselves. Of the 94 patients who participated in the study, hearing loss occurred in 29 of 44 participants who received Cisplatin only. That was 65 percent. However, only 19 out of 50 patients, or 38 percent, experienced hearing loss when STS was administered following Cisplatin chemotherapy.

“PedMark has been in development for 10 years, and this year is very important. The findings from the European-based trial reflected the findings from a U.S.-based trial in 2014,” said Andrade. “We will now focus on gaining regulatory approval to ensure a real impact on our patients’ quality of life and their ability to maintain their hearing.”

Funding development of STS

Founded in Canada in 1996, the company moved its headquarters to RTP in 2004. Originally known as Adherex, the company changed its name to Fennec and began exclusively focusing on the development of STS in 2014. The company draws its name from the fennec fox, which has distinctively large ears which dissipate heat and provide very sensitive hearing.

In September 2017, the company announced that its shares of common stock were approved for listing on the Nasdaq Capital Market under the symbol “FENC.”

“We look forward to the expanded visibility, improved liquidity, and the potential diversification of our stockholder base that the trading on the Nasdaq may provide as we continue to focus on increasing stockholder value,” said CEO Rosty Raykov in a statement. “Our listing on the Nasdaq represents a significant corporate milestone as we continue our commitment towards serving an unmet medical need for pediatric patients with cisplatin chemotherapy.”

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