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CBP-1011. InKine Pharmaceutical Co.

P Gionchetti¹, F Rizzello

¹Department of Internal Medicine and Gastroenterology, 59 Via S Vitale, University of Bologna, Italy. paolo@med.unibo.it

Idrugs : the Investigational Drugs Journal

|June 24, 2005

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Medroxyprogesterone acetate (CBP-1011) is an investigational corticosteroid for inflammatory conditions. It is in Phase III trials for idiopathic thrombocytopenic purpura and has completed Phase II for inflammatory bowel disease.

Area of Science:

Immunopharmacology
Gastroenterology
Hematology

Background:

CBP-1011, medroxyprogesterone acetate, is an immunosuppressant corticosteroid.
It is under development by InKine Pharmaceuticals for inflammatory conditions.

Purpose of the Study:

To evaluate CBP-1011 for treating idiopathic thrombocytopenic purpura (ITP).
To assess CBP-1011 for inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC).

Main Methods:

Phase III clinical trials are ongoing in the US for ITP.
Phase II trials for IBD were completed by December 2000.
A patent describes methods to increase Fc receptors on white blood cells and macrophages.

Main Results:

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The FDA granted Orphan Drug designation for CBP-1011 in treating thrombocytopenic purpura in March 2001.
A patent was issued for methods of stimulating phagocytosis by increasing Fc receptors.
Medroxyprogesterone acetate is claimed for treating IBD, CD, UC, food allergies, hemorrhoids, and psoriasis.

Conclusions:

CBP-1011 shows potential for treating various inflammatory and autoimmune conditions.
Further clinical trials are necessary to establish efficacy and safety.