S C I E N C E   A N D   T E C H N O L O G Y

Havana. December 10, 2004

CUBAN VACCINE AGAINST LUNG CANCER
Clinical trial to begin in U.S. in 2005
• Batches to be manufactured at new plant constructed at the Genetic Engineering and Biotechnology Center

 BY LILLIAM RIERA —Granma International staff writer—

• THE Cuban therapeutic vaccine against lung cancer is to move onto the clinical trials stage in the United States for its subsequent registration in that country, according to José Miyar Barruecos, secretary of the Council of State.

Lung cancer causes more than half a million deaths per year in the United States.

Developed in the Center for Molecular Immunology (CIM), one of the institutes within the  West Havana Scientific Complex, the vaccine is based on the epidermal growth factor (EGF) – a protein closely related to cellular growth – and was submitted for clinical trials on the island with evident advantages for patients’ survival.

Inside the CIM’s modern laboratories, a total of 22 products are under investigation, including monoclonal antibodies such as CIMAher (used with promising results on brain and neck tumors, in combination with radiotherapy) and therapeutic vaccines for the treatment of cancer.

It was also announced that important investments in the center will allow scientists to cover national demand of CIMAher (registered in Cuba in 2002 and patented in 17 nations, including the U.S.) and begin exportation.

During a tour of various sections of the Center by Health Minister Dr. José Ramón Balaguer, it was also reported that a new plant has recently been constructed at the Genetic Engineering and Biotechnology Center (CIGB) specifically devoted to manufacturing the batches destined for the EGF vaccine’s clinical trial.

The plant, expected to begin production in the first trimester of the coming year, boasts state-of-the-art technology from the so-called First World.

On July 15 of this year in the Cuban capital, CIM and U.S. firm CancerVax Corporation in California signed an agreement – the first in 40 years – in the presence of President Fidel Castro, for the transference of biotechnological technology for the cooperative production of anti-cancer vaccines.

The fact that there is no tradition of South to North transference of technology – particularly in the field of biotechnology, was highlighted on that occasion by CIM director Dr. Agustin Lage, who recalled the contact between the Cancervax Corporation and this Cuban institution in 2001 when the island produced the first clinical results for its vaccine against lung cancer.

The CIM director also recalled that following this, Donald Morton, director and chief surgeon for the John Wayne Cancer Institute in Los Angeles visited Cuba and set in motion the contact process that, after more than three years of negotiations, resulted in the signing of the agreement.

Dr. Morton described the Cuban anti-cancer vaccines – designed to stimulate the immunological system – as a “unique and unprecedented discovery” during a video message sent to the participants at the signing of the agreement.

 INGREDIENTS FOR ANTI-MENINGITIS, PNEUMONIA AND OTITIS TO BE PRODUCED

At the CIGB’s other new plant – in operation since August – technicians are producing the active pharmaceutical ingredients for the Cuban vaccine against Type B Hemophilus influenzae, a bacterium responsible for an significant percentage of meningitis, pneumonia and otitis cases, causing the deaths of half a million children worldwide.

The only one of its kind in the world to reach laboratory level, this vaccine – trade name Quimi-Hib – “will permit the country to save between two and three million dollars a year from imports used in the National Immunization Program,” Dr. Vicente Vérez Bencomo, the vaccine’s principal author, explained to Granma International in an interview in June 2003.

Capable of producing 10 million doses a year – enough to cover 100% of the country’s needs – this plant can increase its production fivefold to meet important exports for the World Health Organization.

Investments in technological equipment at CIGB have also favored an increase in the productive capacity and quality of interferons, both for national use and export.

It will also allow them to duplicate the volume of production of the compound vaccine against Hepatitis B (Heberbiovac HB). Next year, the center may well be able to manufacture close to six million infant doses, a figure that would present a great opportunity to supply other regions of the world with this medicament.