Priothera Ltd. lero yalengeza kuti bungwe la US Food and Drug Administration (FDA) lapereka chilolezo kuti lipitilize kufunsira kwa Company Investigational New Drug (IND) kuti iyambe maphunziro ake ofunikira a Phase 2b/3 pa mocravimod (wotchedwa MO-TRANS).
Priothera adzayambitsa maphunziro a MO-TRANS Global Phase 2b/3 ku Europe, US ndi Japan, ndikuwunika mphamvu ndi chitetezo cha mocravimod ngati chithandizo chothandizira komanso chothandizira odwala Acute Myeloid Leukemia (AML) omwe akudwala allogenic hematopoietic stem cell transplant (HSCT) ). Kafukufuku wa MO-TRANS akuyembekezeka kuyamba mu theka lachiwiri la 2022 ndipo zoyambira za kafukufukuyu zikuyembekezeka kumapeto kwa 2024.
Allogenic stem cell transplantation ndiyo njira yokhayo yomwe ingathe kuchiritsa odwala a AML, komabe njira zochiritsira zamakono zimagwirizanabe ndi zotsatira zambiri, komanso chiwerengero cha imfa.
Florent Gros, Co-Founder ndi CEO wa Priothera, anati "Chilolezo cha FDA IND kuyambitsa kafukufuku wa MO-TRANS kuyesa mocravimod mwa odwala a AML omwe akudwala allogeneic HSCT ndi chinthu china chofunika kwambiri kwa Priothera. Tili pachiwopsezo choyambitsa mayeso ofunikirawa a Phase 2b/3 ndipo tikuyembekezera kugwira ntchito limodzi ndi gulu lalikulu la ofufuza achangu ku US, Europe ndi Asia, omwe ali ndi cholinga chobweretsa mocravimod kwa odwala ngati chithandizo chothandizira komanso kukonza. kwa AML komanso matenda ena a hematologic.
ZOMWE MUNGACHITE PA NKHANIYI:
- We are on track to initiate this pivotal Phase 2b/3 clinical trial and are looking forward to working alongside a large team of enthusiastic investigators across the US, Europe and Asia, who share our goal of bringing mocravimod to patients as an adjunctive and maintenance treatment for AML and potentially other hematologic malignancies.
- Priothera will initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult Acute Myeloid Leukemia (AML) patients undergoing allogenic hematopoietic stem cell transplant (HSCT).
- The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.
