Ustekinumab
CNTO 1275 is the experimental name for the human immunosuppressive drug ustekinumab developed by the biotechnology company Centocor. It is a laboratory-manufactured, monoclonal antibody directed against interleukins IL-12 and IL-23 and presently undergoing clinical trials to determine its safety and effectiveness against the diseases Multiple Sclerosis, Psoriasis, and Psoriatic Arthritis.
Once released for public use, administration and dosage of the drug will most likely by doctor's prescription and direction only.
Development
As of January 2007, there were 5 NIH-listed research studies involving CNTO 1275 on a multinational basis, including 3 Phase II and 2 Phase III trials. Three studies are focused on patients with psoriasis, one on psoriatic arthritis, and one on Multiple Sclerosis.
CNTO 1275 is not yet approved by the U.S. Food and Drug Administration.
On December 4, 2007 Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) was filed by Centocor and Janssen-Cilag International (collaborator) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA).
On June 17, 2008, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration unanimously recommended the approval of ustekinumab (CNTO 1275) for the treatment of adult patients with moderate to severe plaque psoriasis. The decision by the committee is non-binding and final decisions on approval of the drug are made by the FDA. As yet, there is no schedule for when the FDA will make a decision on CNTO 1275.
Delivery
Note: Because the drug is not yet released for public use, the official drug's prescribing information and disclosure (required by federal law) is not available.
Patients enrolled in clinical trials of CNTO 1275 are scheduled to receive the drug by subcutaneous injections at doses of either 45 or 90 mg. The dosage and frequency varies by study and application (type of disease targeted). Generally the initial dosing interval is once per week followed by a step-down to once per month or even once every three months.
Mode of action
Similar to the immunosuppressive function of Etanercept (Enbrel), CNTO 1275 is designed to interfere with the triggering of the body's inflamatory response through the suppression of certain cytokines. Specifically, CNTO 1275 blocks interleukin IL-12 and IL-23 which help activiate certain T-cells.
External links
- CNTO 1275 research studies registered with U.S. National Institutes of Health:
- Sylvester, Bruce (2006-03-06). "CNTO 1275 Shows Efficacy for Psoriasis: Presented at AAD". Doctor's Guide Publishing. Retrieved 2007-01-25.