PROMETIC REPORTS POSITIVE CLINICAL DATA FROM ITS INTRAVENOUS IMMUNOGLOBULIN (IVIG) PIVOTAL PHASE 3 TRIAL - 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, QUEBEC, CANADA – April 30, 2018 – 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.
Secondary endpoints including episodes of fever (=100.4°F), number of missed days, number of days of hospitalization due to infection, number of days on antibiotics, number of infections other than SBI, and trough IgG level were comparable between Prometic’s IGIV and commercial drugs. Only 4.94 days/subject/year were lost from work with Prometic IGIV 10%, which was significantly less than the rate observed while on commercial product.
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