MedPath

PRTX-100

Generic Name
PRTX-100
Drug Type
Small Molecule
Background

PRTX-100 is a highly-purified form of Staphylococcal Protein A that binds directly to monocytes and a subset of B-cells that are involved in the development and progression of various autoimmune diseases. These binding interactions enable the compound to modulate the function of these cells and restore the balance of the immune system.

Indication

Investigated for use/treatment in autoimmune diseases, inflammatory disorders (unspecified), rheumatoid arthritis, and thrombocytopenia.

PRTX-100-203 Open-Label, Dose Escalation Study in Adult Patients With ITP

Phase 1
Terminated
Conditions
Immune Thrombocytopenia
Interventions
First Posted Date
2015-10-02
Last Posted Date
2019-03-25
Lead Sponsor
Protalex, Inc.
Target Recruit Count
15
Registration Number
NCT02566603
Locations
🇫🇷

CH Lyon Sud, Pierre-Bénite, Lyon, France

🇫🇷

Côte de Nacre Hospital, Caen, France

🇫🇷

Mondor Hospital, Créteil, France

and more 13 locations

PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP

Phase 1
Terminated
Conditions
Immune Thrombocytopenia
Interventions
First Posted Date
2015-03-27
Last Posted Date
2019-07-05
Lead Sponsor
Protalex, Inc.
Target Recruit Count
13
Registration Number
NCT02401061
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Gabrail Cancer Center, Canton, Ohio, United States

🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

and more 8 locations

6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection

Phase 1
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2015-01-05
Last Posted Date
2018-10-16
Lead Sponsor
Protalex, Inc.
Target Recruit Count
13
Registration Number
NCT02330445
Locations
🇺🇸

Protalex Investigational Site, Coeur d'Alene, Idaho, United States

Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis

First Posted Date
2012-12-17
Last Posted Date
2014-12-23
Lead Sponsor
Protalex, Inc.
Target Recruit Count
61
Registration Number
NCT01749787
Locations
🇺🇸

Protalex Investigational Site, Allen, Texas, United States

🇺🇸

Protalex Investigative Site, Los Angeles, California, United States

Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP

Phase 1
Terminated
Conditions
Idiopathic Thrombocytopenic Purpura (ITP)
Interventions
First Posted Date
2007-12-12
Last Posted Date
2018-07-20
Lead Sponsor
Protalex, Inc.
Target Recruit Count
9
Registration Number
NCT00571467
Locations
🇦🇺

St. George Hospital, Sydney, New South Wales, Australia

🇦🇺

Canberra Hospital, Garran, Australian Capital Territory, Australia

🇦🇺

Royal Brisbane, Brisbane, Queensland, Australia

and more 4 locations
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