CNTO 1275

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.

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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).

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.

• CNTO 1275 research studies registered with U.S. National Institutes of Health:
  • Phase II Study on Multiple Sclerosis (NCT00207727)
  • Phase II Study on Psoriasis (NCT00320216)
  • Phase III Study on Psoriasis (NCT00267969)
  • Phase III Study on Psoriasis (NCT00307437)
  • Phase II Study on Psoriatic Arthritis (NCT00267956)

• Sylvester, Bruce. "CNTO 1275 Shows Efficacy for Psoriasis: Presented at AAD", Doctor's Guide Publishing, 2006-03-06. Retrieved on 2007-01-25.