Novo Nordisk bags CDSCO panel nod to study anti neoplastic drug Concizumab
New Delhi: In line with the drug major Novo-Nordisk's proposal for Phase IIIa clinical trial of antineoplastic drug Concizumab, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to conduct the study.
This came after the firm presented the proposal to conduct the Phase IIIa clinical trial of anti-neoplastic drug Concizumab.
Concizumab is a clinical stage anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody. It is a humanised IgG4 construct that was developed by Novo Nordisk as a novel therapeutic for genetic bleeding disorders.
Concizumab binds to the Kunitz-type protease inhibitor (KPI) 2 domain of TFPI and blocks its interaction with the active site of FXa. TFPI is an endogenous anticoagulant protein whose pharmacological inhibition restores hemostasis.
Concizumab is an antibody that targets a natural anticoagulant protein called tissue factor pathway inhibitor. By blocking the anticoagulant, concizumab facilitates the production of thrombin, a blood-clotting protein. This may prevent spontaneous bleeds by improving blood coagulation.
Analysing the risk verus benefit to the patients, the committee observed the safety profile of the study drugs from preclinical toxicology studies including repeat dose toxicity study and Phase I & Phase II clinical study data justify the conduct of the trial.
Furthermore, in line with the innovation versus existing therapeutic option the expert panel found the purpose of the study is to establish superiority of Concizumab prophylaxis in Concizumab-naïve children <12 years with haemophilia A or B with inhibitors compared to their previous on demand treatment on the number of treated spontaneous and traumatic bleeding episodes.
In addition, the committee also noted that the test drug may potentially provide treatment in children <12 years with haemophilia A or B with inhibitors.
At the recent SEC meeting for Oncology and Hematology held on 12th April 2022, the expert panel reviewed the proposal presented by the drug maker Novo-Nordiskto conduct the Phase IIIa clinical trial of Anti-Neoplastic Drug Concizumab.
After detailed deliberation, the committee recommended for grant of permission to conduct the study.
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