Cuba USA

Cuban biotechnology: three decades later

By Lisandra Fariñas Acosta

Source Cuba Contemporanea

Any connoisseur who knows how complex, slow and expensive the processes of the biotechnology sector are, had hesitated for what is now a reality. The important development of the Cuban biotechnology in the last thirty years has become one of the more established industries in the third world.

Grouped into a young business organization, BioCubaFarma, which is part of the old "Scientific pole", more than 40 companies, and 12,000 workers and of them some 7000 scientists, continue working on research-oriented public health - as it was its purpose since the 1980s.

Center of Molecular Immunology

The impact of the Cuban biotechnology in the Cuban population health indicators is very important, in the view of Dr. Tania Crombet, Director of clinical research of the center of Molecular Immunology (CIM).

During the recently held Cuba-Brazil workshop on the generalization of the use of the human erythropoietin, recombinant in the national system of health - leading product of CIM, major impact product on the Cuban public health care in the treatment of anemia in patients with chronic kidney disease, and also at the account of the last three decades in this industry, "whose reason of being has been always to achieve a high accessibility of medications that we develop to all patients who need it and thereby a high population coverage".

"To substantially modify health indicators, our goal does not end in the registration of the drug, but it then we ensure its introduction in the public health system, as a guarantee to detect any possible adverse events," said the researcher.

Over three decades the Cuban biotechnology industry has contributed more than 30 vaccines for infectious diseases and over 30 oncology products, some reported and others under scientific investigation. It boasts more than 20 products in cardiovascular disease research and a dozen other chronic and autoimmune diseases, primarily diabetes mellitus, multiple sclerosis and rheumatoid arthritis.

According to Dr. Tania Crombet, profile of the Cuban biotechnology industry research has resulted in an important package of more than 230 patents on the island, and more than 1800 international applications of Cuban patents.

Institutions and leading products

One of the scientific institutions of greatest impact on the Cuban public health is the center of immunoassay (CIE), designed with the Mission of ensuring the strategies, technologies and reagents needed for the integral active research of the leading causes of morbidity in the Cuban population. Its 27 years of work continued on the development of various health programs using the sum (Micro- analytical Ultra system) technology have become an indispensable institution today in the prevention, diagnosis and treatment of diseases.

Its programs include maternal and child care, certification of blood, epidemiological surveillance, and the general program for the Control of Cancer, including prostate, colon, breast and uterine cervical cancer, and which today priority is given to the high incidence of this disease in Cuba.

Dr. Tania Crombet said that within diagnostic kits developed by the CIE are those used for the search for prenatal and neonatal, which allow to diagnose diseases before birth of the child and then. Also mentioned a group of kits in development for neoplastic diseases, "very innovative and for which we predict a high impact in Oncology".

For the early diagnosis of uterine cervical cancer and its precursor lesions, the Cuban scientist concerned that ICN has a complete technology package, which includes a personal, completely sterile and disposable cytology kit to ensure all conditions of asepsis and a high quality in cytology sampling, in order to detect any lesion of the cervix.

"As a complement to this kit we have the Digital Video (SUMASCOPE), which allows a more in-depth study of patients that are detected positive in cytology test", she added.

The immunoassay Center develops also a kit for the quantification of prostate-specific antigen - PSA - total and free, which lets you make an early diagnosis of prostate cancer. "While this method is still controversial in its impact in the reduction of prostate cancer, we believe that in our case will be a tool for evaluating groups of men who can suffer from this disease and conduct more complete studies that indicate the prevalence of this type of cancer," said the researcher.

In this regard she mentioned also the Diagnostician SUMASOF, "to locate the presence of blood human hidden in feces, important for the timely detection of colon-rectal cancer and which allows a very important research in the population at risk."

In addition to the CIE, other institutions that are accumulating great results for the Cuban biotech industry today is the center of genetic engineering and biotechnology.

The Heberprot-P has received the patent in dozens of Nations

Within the range of products of the IGBC, Dr. Crombet highlighted the Heberprot-P - only replacement therapy developed in the world able to achieve effective granulation and enhance healing foot ulcers in diabetic foot - and the introduction of pentavalent vaccines as the vaccine HEBERPENTA, which combines five antigens against diphtheria, tetanus, whooping cough, hepatitis B and Haemphilus influenzae type B, and recombinant vaccine Heberbiovac HB, hepatitis B. The latter, besides being safe and immunogenic and to protect against the virus of hepatitis B and its aftermath, it's a good ally in the control of hepatitis type D.

About this vaccine, introduced by the CIGB, in 1991, the specialist emphasized the considerable impact that has had on reducing the incidence in different groups of patients. "Even though that date has reported 300 cases in patients younger than 15 years, and 70 in less than 5 years, in the year 2012 was practically diagnosed a single Cuban patient carrier of hepatitis B, which is not only very important from the point of view of the infection, but in the fact that we are also doing liver cancer prevention".

The Finlay Institute also stands out as one of the scientific centers of impact within Cuba's biotech industry. Its fundamental role is the development of prophylactic against infection vaccines. In particular, the scientist stressed the register of the vaccine VA-MENGOC - BC ®, which protects against meningococcal serogroup B and C-induced disease, and is the only available vaccine against the meningococcal serogroup B, which has proven to be safe, efficient and effective. Additionally protects against serogroup c meningococcus.

With the use of this product was solved the main problem of the nation's health in the 1980's. The epidemiological impact has been demonstrated with the substantial reduction in invasive disease by meningococcus, when you compare the incidence between pre and post vaccination. A greater than 90% effectiveness was reported. The vaccine is included in the scheme of immunizations in the country since 1991, managing all the children from 3 months of age. The incidence has remained with pre-epidemic rates or less, after the use of the vaccine.

Cancer as a priority

The center of Molecular Immunology (CIM) is a key element within the Cuban industry. "The founding of this institution comes from the National Institute of Oncology and radiobiology, therefore the specialization of research of our Center is primarily cancer," explains the researcher Tania Crombet, who is Director of clinical investigations of the CIM.

"From the production point of view, is distinguished by the fermentation of higher cells, the production of two types of not monoclonal molecules and cancer vaccines." The profile of research of the CIM in terms of diseases and types of molecules, coincides with what prevails in biotechnology around the world: cancer, a condition of high prevalence and monoclonal antibodies, currently of the most investigated molecules on the planet.

"We have a very ambitious agenda, which includes 25 drugs in research. We not only have cancer vaccines and monoclonal owners but that we also develop a group of monoclonal antibodies that are classified as similar. In the case of these last, the original drug patent expired and we therefore intend to introduce a similar of monoclonal antibody".

Example of this is the project of the CIM engaged in Cuba develop a similar monoclonal antibody anti CD-20, which has high impact in the therapy of lymphoma not Hodkins, and which would be the first of its kind developed in the country. Other investigations are related to the molecule antiher2, which is known as Trastuzumab and having a positive effect in the control of cancer of the breast and stomach, said the specialist.

Within the group of CIM products stand out also the stimulating factor of formation of colonies granulocyte recombinant, gCSF, for the treatment of neutropenia, which has 20 international registrations; monoclonal antibody Itolizumab for the treatment of severe psoriasis, which allows a reduction of up to 70% of the severity of the disease; and nimotuzumab monoclonal antibody. "From the point of view of Oncology, is the drug of greater impact on our picture of public health the latter. Three records of the Agency has obtained Cuban regulatory and other 30 records out of Cuba, in the head and neck, glioma and esophagus cancer indications. Not used as monotherapy, but in combination with conventional oncological therapies, radio or chemo", said the expert.

The CIGB has the merit of having developed also two therapeutic vaccines against cancer, registered in Cuba. "They try to raise immune responses against antigens that are relevant in the tumor."

In the case of the vaccine Cimavax EGF, the phase 3 clinical trial showed a significant increase in the survival of patients with advanced lung cancer who received this product.

According to the Statistical Yearbook of health (2013) the leading cause of cancer mortality corresponded to the lung both for men and for women. "More than 5,000 new cases of lung cancer are diagnosed a year and more than 5,000 patients die as a result of a tumor in this body organ," explained Dr. Crombet.

"The vaccine helped all patients who were enrolled in this clinical trial, but a subgroup of patients had much higher benefits. We are trying to make a biomarker that will allow us to predict what type of patient which EFG, which is the target of the vaccine, are in very high concentration in serum via. Therefore, we not only have a new vaccine with benefits for all immunized patients but we are in the path of validating what the predictive biomarker of maximum efficiency, which would also allow direct vaccination to the Group of people in which a much greater benefit is anticipated" said the specialist.

Also aimed to lung cancer, the IGBC also develops therapeutic vaccine Vaxira (racotumomab), for the treatment of non-small cell lung cancer. "It is based on the recognition of an Antigen that appears in many types of tumors. With this medication have a trial phase 3 which allowed us to register by the Cuban regulatory agency. We proved an impact of survival, but also quality of life".

According to the specialist, the national program of Cancer of Cuba provides for the inclusion of a broad group of drugs developed by the biotechnology industry. "Our goal is not only to conclude with a record of drugs and demonstrate that we have hundreds of people with benefits, but each of the patients who require these drugs to receive it."

For Dr. Tania Crombet, "biotechnology has allowed to have not only new drugs, but a paradigm shift in the type of treatment to follow. Until today conventional cancer patients receiving therapy with medications that are extremely toxic not distinguishing between a normal tissue and tumor tissue, so it could be treated only of acute form".

"Chemotherapy was from 4 to 6 cycles because there was a limiting toxicity, and irradiation also has a possible maximum dose. Biotechnology makes a distinction of tumor tissue and healthy tissue, allowing that the treatment of the cancer patient to be chronic, long-lasting, and that even after the tumor progression can continue since they are drugs that do not impair the quality of life".

"Biotech products allow us to reach the actual patient because they do not require a patient that is free of morbidities. They are safe drugs."

- See more at: http://www.cubacontemporanea.com/en/news/11606-cuban-biotechnology-three-decades-later#sthash.jxEIb3wo.dpuf

- The Humane Work Of A Cuban Doctor
by Nuria Barbosa Léon source Granma International The experience of providing services in Venezuela left its mark on Cuban cardiologist Daysi Luperon Loforte, who worked in the municipality of El Tigre, in the state of Anzoátegui, from 2006 to 2010...

- Interview From Havana With Dr. Agustín Lage, Director Of The Molecular Immunology Center Of Cuba
Cuba is well known for its world class health-care, but also for its scientific research in the field, in places such as the Molecular Immunology Center, which develops new products to diagnose and treat cancer. Such institutes are also now profitible...

- Ebola Stimulates Corporate Appetites
By Manuel Yepe “History shows that behind every outbreak of such diseases is the drug cartel, one of the most powerful, influential and wicked of world industries.” This is the conclusion derived from an investigation carried out by Russian news agency...

- Scientific Research In Cuba Converted Into Health
Source: juventud rebelde Along with the Director Generals of the World and Pan American Health Organizations, Army General Raúl Castro Ruz, President of the Councils of State and Ministers, presided over the inauguration of the new headquarters...

- Science, Knowledge And Development. Interview To Agustin Lage, Director Of The Molecular Immunology Center In Cuba.
By Dr Alina Pérez Alina Pérez: The scientific development of health in Cuba has been focused on the biomedical over the social. How can these two aspects go hand in hand? Agustín Lage: The division between biomedical and social sciences...

Cuba USA