Компания BIOTRON успешно завершила КИ II фазы новой терапии от гепатита С
Australian drug developer Biotron may have found a potential cure for Hepatitis C.
Biotron on Friday said that all patients who completed a phase II clinical trial of its antiviral drug, BIT225, in combination with other drugs, had undetectable levels of Hepatitis C 12 weeks after ceasing treatment.
An undetectable level of Hepatitis C virus 12 weeks after completion of treatment is considered to be "a prediction of permanent clearance of the virus and, effectively, a cure", Biotron said.
The news pushed up Biotron shares five cents, or 50 per cent, to 15 cents.
Biotron managing director Dr Michelle Miller said data from the trial supported BIT225 as a potential new therapy for Hepatitis C, especially for patients with both HIV and Hepatitis C who typically had more serious Hepatitis C infection and fewer treatment options.
"Both HIV and HCV viruses present substantial challenges for treatment and represent multi-billion-dollar markets," Dr Miller said.
"We look forward to progressing commercialisation of BIT225 as a valuable new therapy that will work in combination with current and future treatment strategies."
Dr Miller said treatment including BIT225 could benefit patients in that it was more effective, required a shorter treatment time and was less expensive.
The phase II trial in Bangkok involved eight patients with HIV and Hepatitis C.
Biotron said although the number of patients in the trial was small, the fact that 100 per cent had no Hepatitis C virus detected from the 12th week into the trial onwards was encouraging evidence of BIT225's efficacy.
Dr Miller said the next important step in the development of BIT225 for the treatment of Hepatitis C would be the results of a larger trial involving 60 patients.
Preliminary data from the larger trial is expected before the end of 2014.
Hepatitis C is one of five viruses causing Hepatitis, which means inflammation or swelling of the liver.
A chronic Hepatitis infection can result in liver damage.
Hepatitis C is spread through blood-to-blood contact.
The eight patients starting the Bangkok trial received "standard" Hepatitis C drugs - interferon and ribavirin - for seven days before starting treatment with BIT225.
They then received BIT225 twice a day, plus the "standard" drugs for 28 days.
After that, patients continued to take the interferon and ribavirin until week 48, at which time all treatment stopped.
Three patients withdrew during the first 12 weeks of the study due to intolerance of the interferon and ribavirin treatment.
The remaining five had undetectable levels of Hepatitis C after week 12.
Virus levels continued to be undetected at week 24 and at week 48, when all treatment ceased.
At week 60 - 12 weeks after treatment finished - all the patients who completed the course remained clear of the Hepatitis C virus.