| Revista: | Biotecnología aplicada |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000349778 |
| ISSN: | 0864-4551 |
| Autores: | González, Gisela1 Lage, Agustín1 Crombet, Tania1 Rodríguez, Gryssel1 García, Beatriz1 Cuevas, Ariadna1 Viña, Lisel1 Arteaga, Norkis1 Neninger, Elia2 |
| Instituciones: | 1Centro de Inmunología Molecular, La Habana. Cuba 2Hospital Hermanos Ameijeiras, La Habana. Cuba |
| Año: | 2009 |
| Volumen: | 26 |
| Número: | 4 |
| Paginación: | 345-348 |
| País: | Cuba |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Experimental, aplicado |
| Resumen en inglés | The results allowing the Cuban Regulatory Agency (CECMED) to grant the Sanitary Registration to the CIMAvax-EGF cancer vaccine for advanced non-small cell lung cancer (NSCLC) are shown. This was the first registration of a therapeutic vaccine in Cuba and also the first registration of a lung cancer vaccine in the world. Hence, a unique therapeutic vaccine is offered to lung cancer patients, which will increase survival and their quality of life. For this purpose, significant preclinical, clinical, regulatory, productive and negotiation challenges were to be faced. The results obtained in these fields led to 18 scientific papers published in high impact journals and 4 invention objects, generating several patents in Cuba and other countries. In the pre-clinical setting, immunogenicity, safety and anti-tumoral effects were demonstrated in different animal species. The clinical experience began in 1995. Up to now, five phase I-II clinical trials have concluded in Cuba, two phase II have also concluded, one in Cuba and another one in Canada and the UK, and a phase II-III trial with an optimized schedule as well as a phase III trial are currently in progress in Cuba. In the regulatory field, a fast-track registration strategy was designed and performed. It required novel regulatory conceptions to develop this unique product. A scalable, reproducible and controlled productive process was carried out, together with a quality system that ensured full GMP compliance. Funds for product development came from implementing a novel negotiation strategy: negotiation of intangibles |
| Disciplinas: | Medicina |
| Palabras clave: | Neumología, Oncología, Inmunología, Cáncer, Pulmones, Vacunas, Ensayos clínicos |
| Keyword: | Medicine, Oncology, Pneumology, Immunology, Cancer, Lungs, Vaccines, Clinical trials |
| Texto completo: | Texto completo (Ver PDF) |
