For Yasuo Urata, the president and CEO of Oncolys BioPharma, the health ministry¡¯s approval earlier this month of Telomelysin ¡ª the world¡¯s first virus-based treatment drug for esophageal cancer ¡ª marks the culmination of its decadeslong effort aimed at sparing patients some of the toll of conventional cancer treatment.
On June 8, the health ministry granted full manufacturing and marketing approval for Telomelysin, a viral therapy for esophageal cancer patients who cannot undergo surgery or receive chemoradiotherapy.
¡°We want to bring out treatments that improve quality of life for patients,¡± Urata, 70, said in an interview. ¡°Anticancer drugs are essentially poison. I wanted to put an end to a world where the body and cancer are both fighting to survive.¡±
Compared to traditional treatment methods ¡ª such as surgeries, and chemotherapy that causes side effects including vomiting and hair loss ¡ª Telomelysin is far less disruptive, according to Urata.
Telomelysin is an oncolytic adenovirus treatment, which injects a genetically modified adenovirus ¡ª?designed to multiply only in cancer cells?¡ª directly into tumors. Adenoviruses are one of the families of viruses that can cause the common cold.
The drug is injected into the tumor with a long needle catheter through an endoscope once every two weeks during a six-week outpatient course of radiation. Side effects are said to be mild and may include a low-grade fever.
The company chose to target esophageal cancer first since survival rates for patients who suffer from it are relatively low compared to other cancers, and treatment is often harsh with severe side effects.
One of the conventional treatments for esophageal cancer is surgery, which can take eight to 10 hours. Recovery can be long and painful, and around 40% of patients experience complications. Surgery can be too risky for elderly patients, while some people are unable to receive chemotherapy because of poor liver or kidney function.
For patients who can¡¯t undergo surgery or chemotherapy, Telomelysin can be an attractive option.
In a 36-patient clinical trial, Telomelysin combined with radiation led to the disappearance of cancer in about half of patients after 1? years, showing a higher success rate than radiation alone.
The drug is expected to launch this summer after its price is set. It will initially be sold to about 80 medical institutions, with a goal of expanding sale to 300.
In Japan, other virus-based cancer therapies include Delytact, developed by the University of Tokyo and Daiichi Sankyo, which received conditional and time-limited approval in 2021. Kagoshima University and its startup, Surv BioPharma, are also developing viral cancer treatments.
Urata¡¯s interest in medicine began in the city of Inuyama, Aichi Prefecture, where he grew up in a pharmacy run by his father.
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