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Clinical Trials associated with EGF Cancer Vaccine(In3Bio Research)Phase 3 Open-label, Multicentre, Randomised Trial to Establish Safety & Efficacy of an EGF Cancer Vaccine in Inoperable, Stage IV Biomarker Positive,Wild Type EGF-R NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care
The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase 3 trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.
100 Clinical Results associated with EGF Cancer Vaccine(In3Bio Research)
100 Translational Medicine associated with EGF Cancer Vaccine(In3Bio Research)
100 Patents (Medical) associated with EGF Cancer Vaccine(In3Bio Research)
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Literatures (Medical) associated with EGF Cancer Vaccine(In3Bio Research)01 Mar 2003·Annals of OncologyQ1 · MEDICINE
Epidermal growth factor-based cancer vaccine for non-small-cell lung cancer therapy
Q1 · MEDICINE
Article
Author: F. Torres ; B. Garcia ; T. Crombet ; E. Neninger ; R. Perez ; L. Alfonso ; G. Gonzalez ; R. Lage ; A. Mulet ; M. Osorio ; M. Catala
BACKGROUNDThe role that growth factors and their receptors play in human cancer growth and progression makes them interesting targets for novel treatment modalities. Our approach consisted of active immunotherapy with the epidermal growth factor (EGF). Two pilot clinical trials were conducted to examine the safety and immunogenicity of a five-dose immunization protocol and to compare different adjuvants and treatment designs.PATIENTS AND METHODSForty patients with advanced non-small-cell lung cancer were enrolled in both trials. They were randomized to be treated with aluminum hydroxide or montanide ISA 51 as adjuvants in the EGF vaccine preparation. The use of cyclophosphamide prevaccination treatment was evaluated in the second trial.RESULTSPooled data from both trials showed that the use of montanide as adjuvant increased the percentage of good antibody responders (GAR). Cyclophosphamide prevaccination treatment did not provoke improvements in antibody response. GAR had a significant increase in survival as compared with poor antibody responders. Response duration was also related to a significant improvement in survival rates.CONCLUSIONSVaccination with five doses of EGF vaccine is safe and immunogenic. Montanide ISA 51 increased the percentage of GAR. There is a direct relationship between anti-EGF antibody titers and immune response duration with survival time.
100 Deals associated with EGF Cancer Vaccine(In3Bio Research)