staphylococcal protein A (PRTX-100) / Protalex - LARVOL DELTA

Reaserch Advances in the Treatment of Primary Immune Thrombocytopenia--Review (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi) - "Recently, avatrombopag and fostamatinib have been approved by the FDA for the treatment of primary ITP in adults, while new drugs such as rozanolixizumab, efgartigimod, PRTX-100, decitabine and atorvastatin have shown efficacy in early clinical trials. This review summarizes the current accepted therapies for the clinical treatment of primary ITP in adults, and briefly discuss the progress of new therapies."

Journal • Review • Hematological Disorders • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Study of PRTX-100 in Adult Patients With Persistent/Chronic Immune Thrombocytopenia (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Protalex, Inc.

New P1/2 trial • Biosimilar • Hematological Malignancies • Immunology

Study of PRTX-100 in Adult Patients With Persistent/Chronic Immune Thrombocytopenia (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Protalex, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Hematological Malignancies • Immunology

PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP (clinicaltrials.gov) - P1/2; N=13; Terminated; Sponsor: Protalex, Inc.; N=36 ➔ 13; Active, not recruiting ➔ Terminated; Enough data has been collected to allow analysis of safety profile and risk-benefit.

Clinical • Enrollment change • Trial termination

PRTX-100-203 Open-Label, Dose Escalation Study in Adult Patients With ITP (clinicaltrials.gov) - P1b; N=15; Terminated; Sponsor: Protalex, Inc.; N=30 ➔ 15; Trial completion date: Dec 2018 ➔ May 2018; Recruiting ➔ Terminated; Trial primary completion date: Dec 2018 ➔ May 2018; Enough data has been collected to allow analysis of the safety profile and risk-benefit.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP (clinicaltrials.gov) - P1/2; N=36; Active, not recruiting; Sponsor: Protalex, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2018 ➔ Mar 2019

Clinical • Enrollment closed • Trial primary completion date