Israel’s Ministry of Health has granted biopharmaceutical company Medgenics approval to initiate two Phase I/II clinical trials of subcutaneous autologous tissue implant, Infradure, in patients with hepatitis C.
The company hopes the trials will demonstrate that Infradure biopumps can safely and continuously produce and deliver effective levels of active interferon alpha (IFNa) into patients’ circulation for a sustained period of time.
Previously untreated patients with genotypes 1 and 3 will be evaluated in one trial, and the other will study genotype 1 patients who have relapsed after initially responding to prior treatments.
The first study, which will enrol up to 16 patients with hepatitis C, is expected to start in the fourth quarter of 2012 and last for 24 months, while the second study will be initiated following initial results of the first.
Medgenics strategic advisory board member and Beth Israel Deaconess Medical Center, Liver Center director and hepatology chief Dr Nezam H Afdhal said the first tudy will be important not only for its use in treating hepatitis C, but could lead to the development of interferon therapy produced by the patient’s own tissue for other forms of hepatitis such as B and D.
"Infradure aims to make the most of that natural defense by providing sustained interferon to bolster the immune system while minimising the burdens of patient compliance and reducing side effects," Afdhal said.
"Infradure offers hope not only in hepatitis C, but could also fulfill an unmet need for reliable interferon therapy for hepatitis D, an aggressive form of hepatitis for which IFNa is the only effective treatment.
"It also addresses the emerging need for a practical, time limited alternative to years of expensive oral antiviral treatments for hepatitis B, a disease which afflicts an estimated 350 million patients worldwide."
Medgenics president and CEO Dr Andrew L Pearlman said; "Following the recent Orphan Drug Designation for INFRADURE in hepatitis D, these hepatitis C clinical studies launch our broader hepatitis clinical program."