Skip to main content
Log in

CBP 1011

Colirest™, Hematrol™

  • Adis R&D Profile
  • Published:
Drugs in R & D Aims and scope Submit manuscript

Abstract

InKine Pharmaceutical Co. is developing an oral compound, CBP 1011, for the treatment of immune thrombocytopenic purpura (ITP) [Hematrol™] and for the treatment of inflammatory bowel disorders, ulcerative colitis and Crohn’s disease (Colirest™).1 CBP 1011 or medroxyprogesterone, is a progesterone agonist and inhibits pro-inflammatory mediators such as interleukin-6 and tumour necrosis factor (TNF). CBP 1011 was originally developed by CorBec Pharmaceuticals, which in 1997 was aquired by Panax and then intergrated into InKine Pharmaceuticals.

According to a company spokesperson, InKline is pursuing outlicensing opportunities for Hematrol™ since the company’s current commercial focus is on gastrointestinal products.

In June 2000, InKine announced the completion of a study comparing the bioavailability of a commercially viable tablet formulation of CBP 1011 to the original capsule formulation that is currently being used in the company’s phase III studies in patients with idiopathic thrombocytopenic purpura. Preliminary results from this study indicate that the bioavailability of the tablet formulation does not differ significantly from that of the capsule formulation. The trial enrolled ITP patients (i) who are HIV positive, (ii) who are chronic ITP sufferers despite having had a splenectomy, (iii) who are older, or (iv) who have less severe thrombocytopenia.

In preclinical trials, CBP 1011 was shown to decrease lymphocyte infiltration into the bowel compared with the control. Studies also show that it possibly offers safety benefits over steroid therapies.

In June 2001, InKine commenced enrolment for a pivotal phase III trial in the treatment of Crohn’s disease. This randomised, double-blind trial will enrol approximately 250 patients and will compare two doses of CBP 1011 (400 and 1000mg) with placebo.

In April 2003, the US Patent and Trademark Office granted InKine Pharmaceutical a ‘Notice of Allowance’ for the ‘Method of Treating Inflammatory Conditions with Progesterone or Progesterone Analogs’. This patent for medroxyprogesterone (Colirest™) provides InKine patent protection for the use of Colirest in treating patients with Crohn’s disease, ulcerative colitis, proctitis, microscopic colitis, allergic eosinophilic gastroenteritis, food allergies, drug-induced oesophagitis, coeliac disease, recurrent polyps and haemorrhoids. The patent protection also covers Colirest in a variety of delivery forms such as tablet, enema, suppository, foam, gel, ointment and suspension.[1]

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Table II

References

  1. InKine Pharmaceutical Company Inc. InKine Announces U.S. “‘Notice of Allowance”’ for Colirest-TM Patent. Media Release: 23 Apr 2003. Available from URL: http://www.inkine.com

    Google Scholar 

  2. InKine Pharmaceuticals Company Inc. InKine announces positive results for Colirest (TM) in patients with ulcerative colitis. Media Release: [3 pages], 11 Dec 2000. Available from: URL: http://www.inkine.com

    Google Scholar 

  3. InKine Pharmaceutical Company. InKine Pharmaceutical announces positive results for CBP-1011 in patients with Crohn’s disease. Media Release: [2 pages], 11 Sep 2000. Available from URL: http://www.inkine.com

    Google Scholar 

Download references

Author information

Consortia

Additional information

This profile has been selected from R&D Insight™, a pharmaceutical intelligence database produced by Adis International Ltd.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Adis Editorial. CBP 1011. Drugs R&D 4, 241–242 (2003). https://doi.org/10.2165/00126839-200304040-00005

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00126839-200304040-00005

Keywords

Navigation