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Prometic Reports Positive Clinical Data from its Intravenous Immunoglobulin (IVIG) Pivotal Phase 3 Trial

Prometic
Posted on: 30 Apr 18

Clinical data presented at the Clinical Immunology Society Annual Meeting in Toronto, Canada on April 27-28, 2018

Pivotal clinical trial meets primary and secondary endpoints

Clinical data demonstrates comparable efficacy to commercially-approved drugs

Prometic IVIG's safety and tolerability profiles maintained without any significant drug related issues

LAVAL, QC, April 30, 2018 /PRNewswire/ - Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic)  today announced positive clinical data from its pivotal IVIG phase 3 clinical trial, meeting its clinical primary and secondary endpoints in adult patients suffering from primary immunodeficiencies (PID). The clinical data presented at the Clinical immunology Society Annual Meeting in Toronto on April 27-28 2018 on Prometic's IVIG demonstrated comparable safety and efficacy data to existing commercial IVIG products without any significant drug related safety issues.

The primary end point is the rate of clinically documented serious bacterial infections (SBIs), defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis or visceral abscess. The FDA Guidance for Industry on studies required to support marketing of IGIV states: "…a statistical demonstration of a serious infection rate per person-year less than 1.0 is adequate to provide substantial evidence of efficacy". Since there were no SBIs observed during the study, Prometic IGIV 10% clearly meets this requirement.

For more information:
www.prnewswire.com/news-releases/prometic-reports-positive-clinical-data-from-its-intravenous-immunoglobulin-ivig-pivotal-phase-3-trial-300638716.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 30/04/2018

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