You are here
Patient Enrollment Commences for Phase 2 Trial of Interferon Enhancing Therapy
"With a real medical need for effective MS therapies, this trial is designed to demonstrate the ability of EMZ701 to increase interferon efficacy and recover a large patient population that has lost or is losing responsiveness to current interferon therapies." said Dr. Tony Cruz, Chairman and CEO of Transition.
The Phase II study will enroll 40 relapsing / remitting MS patients currently on interferon-(B) therapy showing renewed disease activity as evidenced by MRI changes. After monitoring MRI activity for 12 weeks while on interferon-(B) therapy alone, patients will receive weekly EMZ701 treatments in addition to their standard interferon-(B) therapy for 24 weeks.
In a Phase I clinical trial, Transition's EMZ701 was well tolerated with a good safety profile. In addition, pre-clinical studies have demonstrated that MS-I.E.T. is significantly more effective than interferon-(B) alone in reducing both symptoms and pathologies associated with MS in multiple animal models.
Transition's interferon enhancing technologies have also demonstrated more potent anti-viral and anti-proliferative effects than interferon alone and may potentially have applications in hepatitis C, hepatitis B and cancer. Transition is focused on the clinical development of its interferon enhancing therapies for MS, hepatitis C and cancer. Worldwide sales of interferon products are estimated to be in excess of US$ 5 billion annually.
MS is a complex and unpredictable progressive disease of the central nervous system in which the protective sheath around nerve fibres, called myelin, is destroyed and replaced by sclerotic patches or plaques. The result is a disruption of the flow of messages from the brain and a loss of motor function.
MS affects one in 1,000 individuals in the US and Europe and an estimated 2.5 million individuals worldwide. Interferon-based products for MS have annual sales in excess of US$2.5 billion representing approximately 70% of the MS therapeutic market.
Source: Transition Therapeutics Inc.