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Havana.  June 25, 2008

Cuba registers therapeutic vaccine for lung cancer


THE first therapeutic vaccine for the treatment of advanced lung cancer has been registered in Cuba, the only one for this type of malignancy world-wide, reported the national news agency, AIN.

Named CIMAVAX EGF, the antigen has been shown to be effective, extending patients’ survival and quality of life, said the doctor of biological science, Gisela González, manager of the project.

The expert explained to the press that the drug was developed at the Molecular Immunology Center (CIM), one of the flagship institutions within Havana’s Scientific Pole.

The first clinical trial was conducted in Cuba in 1995 with more than 400 patients with advanced lung cancer who had previously received conventional treatment with chemotherapy and radiation therapy, González indicated.

The drug’s positive effects include a decrease or disappearance of shortness of breathe, weight gain, better appetite and controllable pain, allowing patients to participate in social life, she said.

She explained that the vaccine which provokes an immune system response and does not have serious side-effects, is composed of two proteins, one from epidermal growth factor and the other, P-64 K, from cell membrane, both produced through DNA recombination methods by the Genetic Engineering and Biotechnology Center.

González indicated that five Phase I trials have been conducted and two Phase II trials, one in Cuba and another in Canada and England.

The results of the Phase II trials showed clinical benefits for patients, as compared with those who did not receive the vaccine, leading to a registration request to the Cuban regulatory agency.

González announced that in 11 hospitals within the country, a Phase III clinical trial is being conducted with 579 patients and that in August of this year Phase II trials will begin in Peru and subsequently in China.

Dr. Tania Crombet, director of clinical research for CIM emphasized that Cuban scientists are investigating CIMAVAX EGF for other epidemoid (solid) cancers and have demonstrated its effectiveness in cases of neoplasia of the lung, head, neck, brain, stomach, breast, rectum, prostrate, cervix, bladder, ovary and pancreas.

Cuba began studies of the new vaccine in 1992 which included pre-clinical trials with laboratory animals and, in 1995, conducted the first clinical trial.

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