To conduct a phase 3 trial on investigational compound, Tremelimumab, in advanced melanoma
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Pfizer and Debiopharm have entered into a co-development agreement to conduct a phase 3 trial of Tremelimumab (CP675,206), a fully human anti-CTLA4 monoclonal antibody, for the treatment of patients with unresectable, Stage IV melanoma. A biomarker will be used to select patients considered likely to respond to Tremelimumab.
As per the agreement, Debiopharm is expected to assume responsibility for conducting the phase 3 trial of Tremelimumab and Pfizer will retain responsibility for worldwide commercialisation of the compound. Financial terms of the co-development agreement have not been disclosed.
Pfizer’s investigational drug, Tremelimumab (CP675,206), currently in phase 2, is a fully human igG2 monoclonal antibody which has been in development for the treatment of advanced melanoma.
Reportedly, in April 2008, Pfizer has discontinued a phase 3 clinical trial for patients with advanced melanoma, after the Data Safety Monitoring Board (DSMB) review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy. Analysis of the data from the trial identified the biomarker which will be used in patient selection for the upcoming trial.
Thierry Mauvernay, executive vice president of Debiopharm, said: “Debiopharm and Pfizer share the same vision of personalised medicine for the benefit of patients and to enhance the effectiveness of medicine. We are proud to enter into a unique co-development partnership with Pfizer to address the unmet medical needs of Melanoma patients.”
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