By Patricia Grogg
HAVANA, Cuba, June 30, 2008 – Cuba’s biotech industry plans to launch on the international market, in the short or medium term, a vaccine for treating lung cancer, which causes the deaths of over one million people a year worldwide.
Sales in Latin America of CimaVax EGF, which can prolong survival and improve quality of life in lung cancer patients, may commence in Peru, where clinical trials with a view to registering the product in the country are due to start in August.
The vaccine, developed by the Centre for Molecular Immunology (CIM) in collaboration with the Centre for Genetic Engineering and Biotechnology (CIGB), was approved on Jun.12 by the Cuban regulatory authority, CECMED, for use in hospitals in this country.
Medical services, even the most sophisticated, are provided free to Cuba’s 11.2 million people. But in the 1990s, Cuba opened its doors to health tourists, which means that foreigners could come to this Caribbean island nation to receive treatment with the vaccine.
CIM scientists told reporters on Tuesday that clinical trials in more than 400 patients with advanced lung cancer showed that CimaVax EGF has no serious side-effects, elicits an immune response and lengthens the lives of patients, as well as improving their quality of life.
The vaccine has undergone seven clinical trials in Cuba, Canada and the United Kingdom, and is presently being used in three further trials, two in Cuba and one in Malaysia. Gisela González, a CIM expert, said that trials are also due to start this year in China.
The vaccine consists of a protein, epidermal growth factor (EGF), combined with another protein that enhances the patient’s immune response against EGF. When EGF binds to its specific receptor on cell membranes, it triggers the cell proliferation mechanism, which is augmented in the case of tumours.
“Upon vaccination, the body produces antibodies that recognise and bind specifically to EGF, preventing the protein from binding to its receptor and initiating cell proliferation. As a result, tumour growth is slowed, to an extent that depends on each patient’s individual response,” a press release said. González, who headed the project that began in 1992, said this is the first vaccine for lung cancer to be registered anywhere in the world. CimaVax EGF has been patented in Cuba, Canada, Japan, South Africa and the United States, among other countries.
The researcher said that sales of the vaccine abroad will be undertaken by different foreign companies through arrangement with Cuba. The Bioven company in Malaysia will cover the market in that country and the rest of Southeast Asia, while YM BioSciences of Canada may handle distribution in North America and Europe.
But the vaccine will continue to be produced in Cuban laboratories, said González, who added that exports will depend on the results of clinical assays and on obtaining registration of the vaccine in each and every interested country.
Special authorisation granted by the U.S. Treasury Department in 2004 permits distribution of the vaccine in the United States, but YM BioSciences needs to complete the clinical trials that were left unfinished due to the bankruptcy of U.S. firm CancerVac, the holder of the permit.
CIM scientists hope that the vaccine’s registration in Cuba will provide an incentive for carrying out the U.S. clinical trials, which are expected to cost about 20 million dollars.
A U.S. law passed in 2000 authorised sales of food to Cuba, despite the nearly half-decade U.S. embargo.
CIM and CIGB are part of the West Havana Scientific Pole, which includes the Finlay Institute of Serum and Vaccines, the Immunoassay Centre (CIE), the National Centre for Scientific Research (CNIC), and the National Bio-preparations Centre (BIOCEN).
These biotech centres carry out the complete product cycle, from R&D to marketing and assessing the impact on health. In total, the country has more than 120 scientific research centres, employing about 30,000 people.
Opened in 1994, CIM is devoted to manufacturing biopharmaceuticals for the treatment of cancer and other chronic, non-infectious diseases, to be used in the Cuban public health system. At the same time it endeavours to make its scientific and productive activities self-sufficient, and to make important contributions to the country’s economy.
Since the early 1980s, the government determined that biotechnology was a priority area for Cuba’s economic and social development. Its support for the sector was maintained even during the crisis of the 1990s, caused by the collapse of the Soviet Union, its main aid and trade partner.
According to official sources, 38 new products were registered in this cutting-edge scientific field in 2007, and in the same year biotechnology became the country’s second most valuable export category after nickel.
Exports from CIGB alone have reached over 340 million dollars since their début, supplying countries in Latin America, Africa, Oceania, Asia and Europe. (IPS)