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Prometic Posts Interim Clinical Data from Ongoing Phase 3 Trial
Prometic Life Sciences shared new interim data from six-month clinical data from its ongoing pivotal IVIG Phase 3 clinical trial in patients suffering from primary immunodeficiencies.
Prometic Life Sciences (TSX:PLI; OTCQX:PFSCF) shared new interim data from six-month clinical data from its ongoing pivotal IVIG Phase 3 clinical trial in patients suffering from primary immunodeficiencies.
As quoted in the press release:
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. Forty-nine 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 3 trial will enable us to complete the clinical portion of our New Drug Submission with Health Canada”, said Pierre Laurin, President and Chief Executive Officer 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”.
Click here to read the full press release.
Source: www.newswire.ca
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