New data mean ProMetic ready to file NDS for IVIG product

Canada-based ProMetic Life Sciences (TSX: PLI) has announced positive interim six-month clinical data from its ongoing pivotal intravenous immunoglobulin (IVIG) Phase III clinical trial in patients suffering from primary immunodeficiencies (PID) following review of the data by the Data Safety Monitoring Board (DSMB), which confirmed no significant safety issues and that efficacy appeared to be comparable to existing commercial IVIG products.

The current data meets Health Canada’s requirements for a New Drug Submission (NDS) filing with at least 20 evaluable PID patients treated with ProMetic’s IVIG for a minimum six-month period together with comparison data from a similar six-month period during which patients received comparable approved commercial IVIG products. 49 adult and 10 pediatric patients have completed at least six months of treatment with ProMetic’s IVIG in the current trial. Comparisons with the approved products include safety, Immunoglobulin (IgG) levels, frequency of infections, use of antibiotics, periods of hospitalization due to severe infections and missed days of school or work.

“These positive interim clinical results from our pivotal IVIG Phase III trial will enable us to complete the clinical portion of our New Drug Submission with Health Canada,” said Pierre Laurin, president and chief executive of ProMetic. “We look forward to eventually commercializing our plasma-derived IVIG in Canada initially and contributing to Canada’s self-sufficiency with regards to plasma-derived therapeutics”.