Protagonist治疗公司前不久宣布,欧洲药物管理局(EMA)已授予PTG-300治疗真性红细胞增多症(polycythemia vera)的孤儿药资格认定。PTG-300是天然激素hepcidin的一种可注射合成肽模拟物,此前已获得美国食品和药物管理局(FDA)授予治疗真性红细胞增多症的孤儿药资格认定。 Protagonist治疗公司前不久宣布,欧洲药物管理局(...
Rusfertide (PTG-300) is a hepcidin mimetic being developed as a non-cytoreductive option to consistently control HCT at < 45% in PV patients.Methods:We report results from two Phase 2 trials investigating the activity of rusfertide in PV patients. The first (NCT04057040) was conducted in ...
治疗真性红细胞增多症..2020年12月2日,Protagonist Therapeutics宣布,美国FDA已授予PTG-300治疗真性红细胞增多症(PV)的快速通道资格,此前该疗法已获治疗PV的FDA孤儿药资格。PV是一
Context: Polycythemia vera (PV) patients are routinely treated with periodic therapeutic phlebotomy (TP) alone or combined with cytoreductive therapy to maintain hematocrit (HCT) <45% and reduce the incidence of thrombosis. TP may not adequately control HCT and results in iron deficiency. Rusfertide...
Key words: Hepcidin, Hematocrit, Rusfertide, PTG-300, Polycythemia Vera, PV, Therapeutic Phlebotomy Download: Download high-res image (567KB) Download: Download full-size image Figure 1. Disclosures Gupta: Protagonist Therapeutics: Current Employment. Valone: Protagonist Therapeutics: Consultancy...
PTG-300是一种皮下注射的铁调素模拟物,正在进行临床开发以潜在治疗β-地中海贫血(一种以慢性贫血及铁超载为特征的罕见病)。PTG-300疗法也可能对其他疾病有潜在益处,比如骨髓增生异常综合征(myelodysplastic syndrome,MDS)、遗传性血色沉着病(hereditary hemochromatosis,HH)、真性红细胞增多症(polycythemia vera,PCV)、亲...
VERIFY: A randomized controlled phase 3 study of the hepcidin mimetic rusfertide (PTG-300) in patients with polycythemia vera (PV).662222Background:聽PV is a myeloproliferative neoplasm characterized by overproduction of red blood cells and increased risk of thrombosis. Patients may require ...
Pharmacokinetics, pharmacodynamics, and tolerability of an aqueous formulation of rusfertide (PTG-300), a hepcidin mimetic, in healthy volunteers: A double-blind first-in-human studyObjectives Rusfertide is a potent peptide mimetic of hepcidin being investigated for the treatment of polycythemia vera...
PTG-300 Eliminates the Need for Therapeutic Phlebotomy in Both Low and High-Risk Polycythemia Vera PatientsBackground. Polycythemia vera (PV) patients are treated with periodic therapeutic phlebotomy (TP) in order to maintain hematocrit levels 45%, thereby potentially increasing their risk of ...
PTG-300Polycythemia VeraPVTherapeutic PhlebotomyBackground . Polycythemia vera (PV) patients are treated with periodic therapeutic phlebotomy (TP) alone or in combination with either hydroxyurea (HU), ruxolitinib (RUX) or interferon (IFN) to maintain hematocrit (HCT) levels below 45% as per NCCN ...