fbpx

Canadian Woman’s Successful Use of Cuban Vaccine Gives Mesothelioma Patients Hope

A Cuban vaccine called CIMAvax EGF, which is currently undergoing U.S. testing for its effectiveness in treating mesothelioma and other cancers, has apparently saved the life of a Canadian woman diagnosed with non-small cell lung cancer.  Judy Bryden of Regina, Saskatchewan was originally diagnosed with the terminal form of cancer back in 2016 and given just a year to live. She initially pursued traditional forms of treatment in Canada, including chemotherapy and radiation therapy. After that protocol failed to stop the advancement of her disease she and her husband began researching alternative treatments, and that is when they learned about the success that the Cubans were having with their remarkable cancer vaccine. They contacted an outfit called CubaHeal, which is specifically set up to help people from outside of Cuba to visit the country for treatment, paid a small fee for the process, then traveled there for treatment and to purchase several doses of the vaccine to bring back to her home. The total cost of the trip was $14,500, a fee that was well worth it as her physician says she is now in remission.

CIMAvax has long been discussed as offering great hope for mesothelioma patients. It activates the immune system against a specific protein that has been identified as facilitating cancer cell growth.  It is already in clinical trials in the United States following an agreement between the Roswell Park Comprehensive Cancer Center in New York and the Cuban government that was struck in April of 2015. The Phase I clinical trial began in January of 2017 and is expected to take at least two years, followed by another year or two for the Phase II portion of the trial. The drug has already been approved for use in Bosnia and Herzegovina, Colombia, Cuba, Paraguay and Peru.



A Regina woman wants to spread the word about a vaccine she received in Cuba that she says has kept her alive.

Judy Bryden was diagnosed with lung cancer in 2016, after returning home from a trip with a cold. She underwent numerous scans and, in November 2016, she began chemotherapy. Bryden said the chemotherapy nearly killed her and didn’t cure the cancer. She went through five radiation treatments, and the cancer survived. Following that, a doctor recommended palliative chemotherapy, suggesting Bryden only had one year to live.

“When they told me I had a year to live, I said I was going to prove them wrong. I didn’t know how, but I was going to prove them wrong,” Bryden said.

Bryden refused a second round of chemo. It was at that time that her husband Lorne Bryden first heard about the Cimevax EGF vaccine.

“I searched the internet and found a company called CubaHeal in Brantford, Ontario,” Lorne said. “They were able to put the whole thing together for us, for a fee, of course.”

“When they found (CubaHeal), there was something about it that just felt right. It just felt right at its core,” said Pamela Bryden, Bryden’s daughter.

Lorne submitted Bryden’s medical information, and went on to pay $135. Bryden was approved for treatment, but they had to travel to Cuba.

The vaccine is currently not available in Canada. Health Canada says that is not because of any known safety concerns about the drug. Instead, Health Canada simply does not actively solicit new drug submissions. No application has been submitted for Cimevax EGF yet.

The vaccine works by targeting the epidural growth factor (EGF) which is a protein found naturally in the body. In certain types of cancers, the body produces too much EGF, forcing the cells to grow and divide uncontrollably.

“The company is responsible for submitting an application to Health Canada, so their product can be approved on the Canadian market. Only once we receive that application, will we review an application,” Health Canada spokesperson Renelle Briand said.

The Brydens returned from Cuba in March 2017, with four doses to be injected every 14 days. A CT scan of Bryden this past February found no cancer.

The treatment isn’t cheap. A trip to Havana, plus a year’s supply of injections, costs about $14,500. But it’s still much less than the $65,000 dollar treatment Lorne found for sale in Tijuana, Mexico.

“I wish Cimevax was here for people, because it’s $1,000 a month that we pay,” Bryden said. “It’s worth it.”

Bryden hopes her story encourages others to try the treatment themselves. A recent CT scan shows the cancer has not spread, and CubaHeal has approved another year of vaccines for Bryden. Lorne is planning to leave on March 19 to go pick up the vaccine.



The incidence of lung cancer has risen dramatically.  It is already projected that near two million new lung cancer cases will occur in the United States resulting in approximately half a million fatal outcomes in 2018 (1).  According to the data provided by the Centers for Disease Control and Prevention (CDC) lung cancer has been assessed as a second leading type of cancer in both men and women.  Screening modalities of contemporary medicine have not yet addressed the issue of diagnosing lung cancer in early stages, resulting in capturing this condition as a progressive disease in most of the patients.  Conventional treatment of non-small cell lung cancer (NSCLC) including surgery, chemotherapy, and radiotherapy has very limited efficacy in advanced stages of NSCLC and has been associated with serious toxicities.  Additional problem represents cancer recurrence after conventional treatment occurring in approximately 40 percent of patients after a period of one year (2).

Cuba has produced 33 new drugs for treating cancer by the year 2012 (3).  The fastgrowing medical scientific research in Cuba continues to produce innovative medicinal products, aiming to significantly increase the quality of life in patients suffering from most complex and serious medical conditions.

VAXIRA (RACOTUMOMAB)

An interesting and novel therapeutic approach that includes programming of body’s own immune system to fight cancer cells was investigated in Cuba.  The research prompted the development of immune therapies including therapeutic vaccines.  Vaxira is a therapeutic vaccine developed to treat NSCLC.  The medicinal product was registered in Latin American countries in 2013, after promising results shown in phase II/III study involving patients with advanced and progressive NSCLC (4).  In this study, patients that received Vaxira showed a significant increase in overall survival comparing to patients who received placebo.  Another study that involved 180 patients investigated the effects of Vaxira following conventional treatment for late-stage, recurrent NSCLC.  The results clearly showed decrease in the progression of NSCLC which directly resulted in prolonged survival periods in patients who previously received the first-line treatment for NSCLC (5).  Finally, a randomized, open-label clinical trial that involved 1082 patients with advanced NSCLC, who received standard first-line therapy, showed the response of stable disease after administering Vaxira (6).

The safety profile of Vaxira was also evaluated in clinical trials described above.  In a phase I study of Vaxira for NSCLC that was focused on patient safety, no serious adverse events that were considered to be related to treatment have occurred.  Related events included local reactions at the administration site including pain, redness, and induration.  Reactions were mild and reversible in nature (7).  Toxicity in more advanced clinical trials of Vaxira was similar to those in the phase I study described above.  Cases of a headache, joint pain, and fever were also observed, however, all events were mild to moderate in nature.

Vaxira was initially developed in Cuba.  The well-recognized efficacy of this medicinal product in the treatment of NSCLC prompted multiple investigations for a wide variety of conditions including melanoma, breast, and lung cancer at different locations worldwide (Spain, Brasil, Singapore).

CIMAVAX-EGF

It has been recognized that malignant cells express epidermal growth factor (EGF) receptor in higher amounts than non-malignant cells.  This particular characteristic of tumor cells enables them to grow more rapidly and spread more aggressively (8).  CIMAvax-EGF vaccine expresses anti-cancer activity by stimulating the production of anti-EGF antibodies, which inactivate the circulating EGF directly inhibiting the proliferative nature of malignant tumor (9).

The effectiveness of CIMAvax-EGF was demonstrated in Phase II clinical trial, conducted in 80 patients with NSCLC, who were previously treated with standard platinum-based chemotherapy.  Patients treated with CIMAvax-EGF showed increased survival trends (10).  A Phase III open-label efficacy study that was conducted on the sample of 405 patients that suffered from a late-stage NSCLC showed a significant increase of 5-year survival in those who received the vaccine.  The 5-year survival rate for vaccinated patients was approximately 16% in comparison to control group, where 5-year survival was 6% (11).  Interestingly, it has been noted that following vaccination, levels of EGF remained low in patients with long-term survival (more than 2 years).  EGF level proved to be a powerful prognostic factor for overall survival and cancer recurrence (12).  CIMAvax-EGF can be administered concomitantly with standard platinum-based cytotoxic treatment for NSCLC.  It is advised to administer the vaccine during or prior to platinum-based treatment in order to achieve the best possible response and efficacy (13).

The safety profile of CIMAvax-EGF was evaluated in the aforementioned clinical trials.  The most frequent reactions associated with the use of CIMAvax-EGF were local administration site reactions including pain and redness, as well as systemic reactions such as fever, headache, chills, and shortness of breath.  It is clear that the benefits of this vaccine outweigh the risks related to the administration of CIMAvax-EGF.

Due to the extensive therapeutic potential of CIMAvax-EGF, a Phase IV clinical trial was launched that enrolled more than 1000 patients with NSCLC (14).  It was shown that the use of this vaccine is safe and beneficial to patients with NSCLC.  Preliminary evidence suggested that besides the increase in overall survival, CIMAvax-EGF improved the quality of life of enrolled patients by increasing the emotional well-being and reducing symptoms and signs of fatigue.

This revolutionary medicinal product prompted new research focused on other types of cancers including prostate cancer and gave hope both to the scientific community and patients that the cure for NSCLC is on the horizon.

Bibliography

1. Cancer statistics, 2018. Siegel RL, Miller KD, Jemal A. s.l. : CA Cancer J Clin, 2018, Vol. 68(1). 7.

2. Survival after recurrent nonsmall-cell lung cancer after complete pulmonary resection. Sugimura H, Nichols FC, Yang P, Allen MS, Cassivi SD, Deschamps C, Williams BA, Pairolero PC. s.l. : Ann Thorac Surg, 2007, Vol. 83(2). 409.

3. Profit vs health? Comparing the business models of Cuban and US pharma. Baden, Denise, Davies, Courtney and Wilkinson. s.l. : Monograph (Working Paper), Southampton, GB University of Southampton 12pp, 2015.

4. A randomized, multicenter, placebo-controlled clinical trial of racotumomab-alum vaccine as switch maintenance therapy in advanced non-small cell lung cancer patients. Alfonso, S et al. s.l. : Clin Cancer Res, 2014, Vol. 20(14).
3660-71.

5. Active immunotherapy in patients with progressive disease (PD) after first-line therapy. Gomez, R.E., Alfonso, S et al. s.l. : 49th Annu Meet Am Soc Clin Onco (ASCO), 2013. Abst 3086.

6. Trial proactive: A prospective, randomized, multicenter, open label phase III study of active specific
immunotherapy with racotumomab plus best support treatment versus best support treatment in patients with advanced non-small cell lung cancer. Roberto E Gomez, Amparo Macias, Tania Crombet, Ana Maria Vazquez et al. s.l. : Journal of Clinical Oncology.

7. An anti-idiotype vaccine elicits a specific response to N-glycolyl sialic acid residues of glycoconjugates in melanoma patients. Alfonso, M et al. s.l. : J Immunol, 2002, Vol. 165(5). 2523-9.

8. Molecular epidemiology of lung cancer and geographic variations with special reference to EGFR mutations. Mitsudomi, T. s.l. : Transl Lung Cancer Res, 2014, Vol. 3(4). 205-11.

9. Clinical development and perspectives of CIMAvax EGF, Cuban vaccine for non-small-cell lung cancer therapy. Rodríguez PC, Rodríguez G, González G, Lage A. s.l. : MEDICC Rev, 2010, Vol. 12(1). 17-23.

10. Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer. Neninger Vinageras E, de la Torre A, Osorio Rodríguez M, Catalá Ferrer M, Bravo I, Mendoza del Pino M, Abreu Abreu D, Acosta Brooks S, Rives R, del Castillo Carrillo C, González Dueñas M, Viada C, García Verdecia B, Crombet Ramos T, González Marinello G. s.l. : J Clin Oncol, 2008, Vol. 26(9). 1452-8.

11. A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non-Small Cell Lung Cancer Patients. Rodriguez, PC et al. s.l. : Clin Cancer Res, 2016, Vol. 22(15). 3782-90.

12. Biomarkers related to immunosenescence: relationships with therapy and survival in lung cancer patients. Saavedra D, García B, Lorenzo-Luaces P, González A, Popa X, Fuentes KP, Mazorra Z, Crombet T, Neninger E, Lage A. s.l. : Cancer Immunol Immunother, 2016, Vol. 65(1). 37-45.

13. Combining an EGF-based cancer vaccine with chemotherapy in advanced nonsmall cell lung cancer. Neninger E, Verdecia BG, Crombet T, Viada C, Pereda S, Leonard I, Mazorra Z, Fleites G, González M, Wilkinson B, González G, Lage A. s.l. : J Immunother, 2009, Vol. 32(1). 92-9.

14. CIMAvax EGF (EGF-P64K) vaccine for the treatment of non-small-cell lung cancer. Crombet Ramos T, Rodríguez PC, Neninger Vinageras E, Garcia Verdecia B, Lage Davila A. s.l. : Expert Rev Vaccines, 2015, Vol.14(10). 1303-11.


Capture-d’écran-2019-05-26-à-14.41.16.png

CubaHeal Research Department:

Back in 1978, a conference was held in Almaty (formerly Alma-Ata), the city in Kazakhstan where the one of the most significant public health declarations emerged. One of the most significant excerpts of the Declaration was the profound role of primary health care in establishing the concept of „Health for All”According to the World Health Organization (WHO), an adequate availability (adequate supply of
healthcare), accessibility (adequate distribution of healthcare) and acceptability (treating all patients with dignity) of a healthcare system is required to ensure the best possible health outcomes in a population.
Cuban healthcare system is established to meet the aforementioned standards, and by many criteria, this
system is currently unique and one of the most efficient healthcare systems worldwide (1) .

National Healthcare Policy Goals

Back in 1983, Cuba introduced a Public Health Law establishing basic principles of the healthcare organization. The main characteristic of this healthcare system is that healthcare represents a right that is available equally to all and is completely free of charge (2) . One of the major differences between Cuban and American healthcare principles is that in Cuba, healthcare is the responsibility of the state. Additionally, the Law promotes global cooperation of health systems and its professionals.

On the contrary, a profit-driven healthcare system in the United States results in great imbalances of knowledge and quality of health services, and more importantly, creates a population that cannot afford a proper healthcare leading to healthcare quality being unpredictable and dependent on the financial state of each individual (3) .

Health Outcomes

National Health System of Cuba, that has been founded on a very effective primary health care, is
producing impressive results. Rates of immunization are amongst highest in the world. Over 98 percent
of children are vaccinated against 13 illnesses by the age of 2 (4) . Antenatal care is provided to 95 percent of pregnant women and mortality rate of infants is 5 per 1000 births. Control of blood pressure at least once per year is available to the entire population (5) . As a result of exceptional healthcare outcomes, Cuba is officially at the top of the list of countries that meet the United Nation’s Millennium Development Goals, focusing on the social components of healthcare services.

Primary Healthcare

The pillar stone of Cuban healthcare system is the primary healthcare institutions. A community-based
polyclinic, covering a population of 30000 to 60000 individuals represents a centerpiece of primary health care. These polyclinics serve as a hub for family doctor and nurse practices, where each family doctor covers a population of approximately 600 to 800 individuals. The polyclinics are also centers for education and training of the new physicians, nurses and other healthcare sciences students. Interestingly, Cuba was one of the first countries worldwide which introduced the concept of family care physicians (6) .
This model of healthcare organization increased the prevention of chronic conditions such as diabetes,
hypertension, heart failure, obstructive pulmonary disorders, and significantly decreased the need for “high-tech“ technologies in diagnosing and treating diseases (7) .

The polyclinics are advancing even today. The goal is to extend the range of health services at the
primary healthcare level. Polyclinics are being equipped with ultrasound, X-rays, endoscopy, emergency
care, immunization, rehabilitation services and many other (1) . Approximately 800 to 1000 patients use
the services daily.

Drug Research and Development

Cuba is investing a significant amount of funds into drug research and development. The approximately
US $1 billion investment in pharmaceutical and biotech industry resulted in the production of innovative
medicines, vaccines and diagnostic kits that are now being sold internationally (8) . The most significant
achievements of drug development will be discussed here.

Serogroup B meningococcal vaccine

Cuba developed and registered this vaccine back in 1989 in order to prevent childhood meningitis. The
United States Food and Drug Administration (FDA) registered this exceptional medicinal product only
recently, in 2014, when it was manufactured by Pfizer.

HeberFERON

The drug has been developed in the CIGB (Center for Genetic Engineering and Biotechnology) of Havana. It is a combination of two interferons. The result of its complex mechanism of action is tumor growth suppression, particularly basal cell carcinoma (CBC) no matter of its size, location and subtype. Although most of the skin carcinomas can efficiently be cured surgically, in some cases, it’s not that
simple (face- surgical procedures are often mutilating causing severe reduction of the quality of patient’s
life).

Heberprot- P

The drug was registered in Cuba in 2006 and, since then, 15 more countries registered it, and more than
100.000 patients around the world have received the treatment with incredible results. The target patients are those with chronic diabetic ulcers resistant to other modalities of treatment (high amputation risk). By its structure, Heberprot-P is an epidermal growth factor (EGF), and it’s administered by injection, locally.

Nimotuzumab

According to the clinical research, Nimotuzumab, due its safety profile, is an excellent ad-on therapy for
the patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN). The study blished
back in 2009, clearly demonstrated that Nimotuzumab, combined with radiotherapy, triples the 30-month survival rate compared to the group of patients who received radiotherapy only.

CimaVax-EGF vaccine

1994 was the year when Cuban Center for Molecular Immunology started investigating this medicinal product for the purpose of treating non-small cell lung cancer (NSCLC). Studies have shown a significant increase in survival of NSCLC patients. Earlier this year, more than twenty years after the product was
developed in Cuba, Roswell Park Cancer Institute in Buffalo, New York, decided to initiate the clinical trial in order to investigate the efficacy and safety of this vaccine for the treatment of patients suffering
from NSCLC.

Melagenina Plus (Vitiligo)

The drug is an alcoholic extract from human placenta. The Melagenina Plus lotion is applied once a day to the affected areas. It causes the repigmentation by stimulating melanocytes in a chromic region of the skin (white patches). Available all around the world for more than 20 years, it claimed the title of miraculous vitiligo drug.

Racotumomab

This interesting vaccine received approval in Latin American countries back in 2013, following
completion of phase II/III study involving patients with advanced and progressive NSCLC. Racotumomab showed a significant increase in survival of patients suffering from end-stage NSCLC. This promising medicinal product is being evaluated in a multinational phase III study aiming to investigate the effects of this vaccine on health outcomes in NSCLC patients (NCT01460472).

In conclusion, it appears from the above that the industry in the United States still does not possess adequate mechanisms in providing innovative medicinal products when compared with Cuba.

HIV/AIDS, Ebola Outbreak

Cuba was the first country in the world recognized by the WHO for eliminating mother-to-child transmission of HIV and syphilis (9) . According to the Center for Disease Control (DCD), up until 2014 in the United States, there were 5419 deaths among the population who acquired HIV through perinatal transmission. Recently, Cuba has sent a large group of physicians in order to fight the Ebola outbreak.

These were just some of the characteristics of Cuban healthcare system that continues to impress and
produce enviable results. There are plenty of lessons to learn from Cubans in terms of proper healthcare
organization with only one goal: to ensure a healthier future.

Bibliography

1. Cuba’s primary health care revolution: 30 years on. http://www.who.int/bulletin/volumes/86/5/08-
030508/en/. [Online] [Cited: February 24, 2018.]
2. Ley No. 41. Ley de la Salud Pública. http://www.parlamentocubano.cu/index.php option=com_content_iew=article&id=257:ley-no-41- salud ublica&catid=46:leyes&Itemid=79. [Online] [Cited: February 24, 2018.]
3. Gray, Bradford H. For-Profit Enterprise in Health Care. s.l. : Washington (DC): National Academies
Press (US), 1986.
4. Eradication of poliomyelitis in Cuba: a historical perspective. P, Más Lago. s.l. : Bull World Health
Organ, 1999, Vol. 77(8). 681-7.
5. Caring for Them from Birth to Deat. C, Perez. s.l. : Lanham, MD: Rowman & Littlefield Publishers, 2008.
6. Health for all: a dream realized in Cuba. CW, Keck. s.l. : Medical and Health Annual. Chicago, IL:
Encyclopaedia Britannica Inc., 1994. 357–362.
7. he Cuban health system: responsiveness to changing population needs and demands. SM, Santana.
s.l. : World Dev, 1987, Vol. 15(1). 113–125.
8. The Curious Case of Cuba. Keck, C. William. s.l. : Am J Public Health, 2012, Vol. 102(8). e13–e22.
9. WHO VALIDATES ELIMINATION OF MOTHER-TO-CHILD TRANSMISSION OF HIV AND
SYPHILIS IN CUBA. s.l. : Saudi Med J, 2015, Vol. 36(8). 1018-9.



In spite of the U.S. embargo and due to the nature of its economic model being less market oriented than its counterparts and more focused on research for the bettering of the quality of life, Cuba has been able to established a strong and vibrant medical research and biotechnology industry with 1.8 scientists per 1000 inhabitants equal to that in the EU. 

In an attempt to meeting internal demand for controlling and treating chronic diseases the biotechnology industry created the West Havana Scientific Pole in the early 1980s that developed informal and innovative scientific practices that became known for being one of the most advanced globally in establishing and developing a sophisticated and robust indigenous bio-pharmaceutical industry focused on human and veterinary vaccines, bioproducts, medicines, monoclonal antibodies, generics and alternative medicines as well as innovative diagnostic means.

Once described as “Cuba’s billion dollar gamble”, the Havana’s Western Scientific Pole is now includes over 40 scientific institutions and R&D facilities with over 900 international patents for new drugs and treatments and employs more than 30,000 workers. Currently, 11 vaccines and more than 40 therapeutic biological compounds as well as immunodiagnosis are produced in Cuba.  Moreover, at present Cuba has 90 new products being investigated in clinical trials while f 91 products being investigated in more than 60 clinical trials.

It is also one of only four countries to have been accredited by the World Health Organisation for the production of Hepatitis B vaccines.

With research centers such as the The Center for Genetic Engineering and Biotechnology (CIGB), The Center for the Production of Laboratory Animals (CENPALAB)the National Center for Biopreparations (BIOCEN) and the Center of Immunoassay and the Center for Molecular Immunology (CIM) Cuba has become a world leader in many fields of specialist medical research.

The following is a list of some of the most important Cuban medical innovations and medical achievements:

HEBERPROT-P

Developed by the Center for Genetic Engineering and Biotechnology (CIGB) in 2007 Heberprot-P is an innovative Cuban product with EGF as the main ingredient given to patients suffering from non healing and non responding diabetic ulcers. Due to its ability to stimulate cell proliferation and tissue healing Heberprot-P remains to be the only alternative treatment to amputation for diabetic foot ulcers.  About 160,000 diabetic foot ulcer patient have been treated with Heberprot-P with successfully reducing the the risk of amputation by 77%. 

CIMAVAX-EGF

CimaVax-EGF vaccine was devised by researchers from the Center of Immunoassay and the Center for Molecular Immunology (CIM) over a period of 25 years. CimaVax is the first world non small cell lung cancer vaccine that works by by stimulating the immune system to produce antibodies that specifically target and bind with epidermal growth factor (EGF) preventing the cancer from spreading throughout the body.CimaVax-EGF is not a preventive vaccine, rather it acts by restraining the growth and division of cancer cells slowing down initiating an immune response to release antibodies to fight the cause of tumor growth

RACOTUMOMAB

A second non small cell lung cancer developed by enter of Immunoassay and the Center for Molecular Immunology (CIM), Racotumomab (also known as Vaxira) is a therapeutic vaccine that works on a molecule level by inducing a cellular and humoral immune response in tumors tissues by blocking the tumor growth, slowing down it’s development and hence increasing patient’s’ life expectancy and improving quality of life. 

NIMOTUZUMAB

Nimotuzumab (CIMAher), also developed Center of Molecular Immunology, is a humanized anti-EGFR IgG1 therapeutic monoclonal antibody and used for the treatment of squamous cell of head and neck cancers, glioma and nasopharyngeal cancers.  Nimotuzumab is used as either as monotherapy or in combination with radiation and / or chemotherapy. Presently research continues to determine if Nimotuzumab can be used for the treatment of other types of cancers.

HEBERFERON

Developed by the Center for Genetic Engineering and Biotechnology (CIGB), Heberferon   is the first non melanoma skin cancer treatment at the complex and advanced stages.  Heberferon is an immunostimulant in which Interferon alpha 2b and gamma recombinants are combined to stimulates the immune system into a response against tumor inhibiting the growth of the tumour while reducing or eliminating lesions without the need for surgery.

VA-MENGOC-BC

Cuban meningococcal BC vaccine (VA-MENGOC-BC®) was developed by the Finlay Institute in Havana due to a meningococcal outbreak in the 1980s. The first of its type, VA-MENGOC-BC is a bivalent vaccine composed of meningococcal B outer membrane vesicles and meningococcal C capsular polysaccharide.  This vaccine has proven to be very effective with very high safety profile

QUIMI-HIB

Although meningitis and pneumonia have been almost erased in the developed world these diseases remain highly problematic in the developing world due the high cost of the vaccine. Cuban researchers at the University of Havana in conjunction with researchers at the university of Ottawa (Canada) have developed the first synthetically produced antigen. Quimi hib Vaccine works by producing antibodies that resist infection from bacteria  that causes pneumonia and meningitis in  a breakthrough aimed at lowering the cost of immunising children in poorer countries is considered to be safer and purer than vaccines developed from live bacterium or virus. 



CubaHeal Research Department

A lifetime risk for a diabetic ulcer in patients suffering from diabetes type 1 or 2 is approximated to 25%,
meaning that every fourth person with diabetes will develop diabetic ulcer (1) . Diabetic foot ulcers
represent a medically significant disease complication, with a high incidence of morbidity and mortality
in the modern world. Risks for the development of this serious condition are well established and
include the loss of sensation as a consequence of diabetes induced neuropathy, previous occurrences
ulcers or amputations, infection, trauma, and the consequences of chronic ischemia due to poor
peripheral vascularization (2) . Contemporary treatment options for diabetic foot ulcers are still limited,
directly resulting in amputation being the frequent therapeutic solution for the majority of severe ulcers.
Recent advancements in medical science regarding treatment for diabetes and its' complications have
shown that the use of epidermal growth factor (Heberprot-P) as the treatment of diabetic foot ulcer may
lead to the complete wound healing, significantly reducing the risk of amputation.

Most Recent Scientific Data

It is now well recognized that diabetic patients have decreased amounts of epidermal growth factor (EGF) in tissues which directly results in wound healing impairment and subsequently to the increased risk of amputation. EGF is directly responsible for the growth of epithelial and subepithelial tissues, and promotes reparation processes of tissues that are damaged (3) .

Heberprot-P is an innovative recombinant human EGF developed for acceleration of healing process of deep and complex ulcers in both neuropathic and ischemic types of diabetic ulcers. It currently represents the unique treatment for the most complicated diabetic wounds which are linked with a high risk for amputation. Efficacy and safety of Heberprot-P have been investigated in numerous clinical trials worldwide, with results demonstrating full wound healing, reduction of ulcer recurrence, as well as a reduction in amputations rates. Heberprot-P has proven to be a safe and well-tolerated treatment option for the treatment of severe diabetic ulcers, with adverse events mostly consisted of mild and transitory local reactions (4) .

Efficacy

A recent extensive meta-analysis involving 2365 participants conducted for the purpose of investigating the effects of growth factors on the healing of diabetic ulcers concluded that growth factors (EGF among them) may lead to complete healing of diabetic foot ulcers (5) . Another meta-analysis and systematic review of literature data conducted on 294 patients also identified favorable patient outcomes following treatment with recombinant human EGF (6) . Efficacy of Hebeprot-P was recently investigated in a clinical study involving patients having extensive, full-thickness lower extremity ulcers. Administration of Heberprot-P resulted in complete granulation followed by complete wound closure in 94% of patients. After one year follow-up, only one patient had a relapse of foot ulcer (7) . The interesting mechanistic of healing effects of EGF (Hebeprot-P) has also been investigated recently. It was recognized that diabetic patients have elevated oxidative stress and low antioxidant reserves. Application of EGF resulted in significant reduction of oxidative stress and elevation in antioxidant reserves, directly returning balance to oxidative processes in diabetic patients (8) .

Safety

The safety profile was recently investigated in the longitudinal, multicenter, post-marketing surveillance study which included 260 patients. The results were in line with the already known safety profile of Heberprot-P. Most frequently reported adverse events were mild and reversible in nature, including localized Burning sensation and pain at the injection site, as well as systemic reactions such as chills and shivering (9) . In conclusion, the benefits of Heberprot-P significantly outweigh the risks of this therapy. Heberprot-P can be safely administered to diabetic patients without the risk of serious and irreversible adverse reactions.

Advancements in Treatment

The recognized therapeutic potential of Heberprot-P prompted another clinical trial that would assess the efficacy and safety of Heberprot-P in patients with high-grade diabetic ulcers. The study is conducted at the eminent Dasman Diabetes Institute in Kuwait. Results of numerous studies are promising and justify the further testing of Heberprot-P, a unique and first-in-class therapeutic option for complicated diabetic ulcers. This provides the opportunity to further evaluate beneficial potentials of Heberprot-P and addresses the unmet medical need of introducing an effective therapeutic modality in the treatment of complex and serious diabetic foot ulcers.

The Unmet Need

An accumulated body of scientific evidence clearly indicates that the use of growth factors (especially recombinant human EGF) is beneficial for complicated diabetic foot ulcers with very high success rates. Current antimicrobial treatments, as well as the broad spectrum of different procedures involving surgery and drugs, have failed to decrease amputation rates and successfully treat this serious complication of diabetes. Heberprot-P is a registered treatment for diabetic foot ulcers in dozens of countries worldwide, and it has been successfully used in over 100.000 patients suffering from complex ulcers.

The need for an effective treatment clearly remains, and Heberprot-P has demonstrated to be an effective solution where standard therapeutic options fail. According to the most current data published by the Center for Disease Control (CDC), more than 100 million Americans have diabetes or prediabetes (10) , which represents a high-risk burden for diabetic foot ulcers, considering that every fourth diabetic patient may develop this condition. Complete regression of the most complicated ischemic diabetic

ulcers has been achieved in a significant portion of diabetic patients. Heberprot-P would address therapeutic needs of patients, in which amputation represents the only treatment option.

Bibliography

1. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK, American Diabetes Association, American Association of Clinical Endocrinologists. s.l. : Diabetes Care, 2008, Vol. 31(8). 1679.

2. Diabetes in America, 2nd Edition. National, Diabetes Data Group. s.l. : National Institutes of Health, Washington, D.C. 409.

3. Epidermal growth factor in the treatment of diabetic foot ulcers: an update. Tiaka EK, Papanas N, Manolakis AC, Georgiadis GS. s.l. : Perspect Vasc Surg Endovasc Ther., 2012, Vol. 24(1). 37-44. 4. Heberprot-P: A Novel Product for Treating Advanced Diabetic Foot Ulcer. Jorge Berlanga DVM MS PhD, José I. Fernández MD, Ernesto López MS, Pedro A. López MD PhD, Amaurys del Río MD, Carmen Valenzuela MS, Julio Baldomero MD, Verena Muzio MD PhD, Manuel Raíces PhD, Ricardo Silva PhD, Boris E. Acevedo MD PhD, Luis Herrera MD PhD. s.l. : MEDICC Rev, 2013, Vol. 15(1). 11.

5. Growth factors for treating diabetic foot ulcers. Martí-Carvajal AJ, Gluud C, Nicola S, Simancas- Racines D, Reveiz L, Oliva P, Cedeño-Taborda J. s.l. : Cochrane Database Syst Rev, 2015, Vol. (10). CD008548.

6. Efficacy of Topical Recombinant Human Epidermal Growth Factor for Treatment of Diabetic Foot Ulcer: A Systematic Review and Meta-Analysis. Yang S, Geng Z, Ma K, Sun X, Fu X. s.l. : Int J Low Extrem Wounds, 2016, Vol. 15(2). 120-5.

7. Efficacy of intralesional recombinant human epidermal growth factor in chronic diabetic foot ulcers. Dumantepe M, Fazliogullari O, Seren M, Uyar I, Basar F. s.l. : Growth Factors, 2015, Vol. 33(2). 128-32.

8. Healing enhancement of diabetic wounds by locally infiltrated epidermal growth factor is associated with systemic oxidative stress reduction. Ojalvo AG, Acosta JB, Marí YM, Mayola MF, Pérez CV, Gutiérrez WS, Marichal II, Seijas EÁ, Kautzman AM, Pacheco AE, Armstrong DG. s.l. : Int Wound J, 2017, Vol. 14(1). 214-225.

9. Characterization of adverse events during the treatment with heberprot-p® in four Cuban provinces. Alina Ramona Alvarez Crespo, Liuba Alonso Carbonell, Isis Belkis Yara Alos, Ana Julia Garcia Milian, María Acelia Marrero Miragaya. s.l. : Horizonte Sanitario, 2017, Vol. 17.

10. National Center for Chronic Disease Prevention and Health Promotion. National Diabetes Statistics Report, 2017. s.l. : Center for Disease Control, 2017.



The Cuban biotechnology industry is known worldwide. The human and veterinary vaccines, bioproducts, drugs, diagnostic means and monoclonal antibodies created by brilliant scientists, in top-level facilities, place Cuba as one of the developing nations, together with India and Brazil, with more advances in this sector.

The BioCubaFarma Business Group, one of the most economically powerful in the country, is responsible for leading the biotechnology and pharmaceutical industries. This organization has registered products and exports to more than 50 countries, has 1,800 patents abroad and its annual income exceeds 2,000 million dollars. Among the institutions attached to the huge Group, which employs more than 22,000 workers, are the Center for Genetic Engineering and Biotechnology (CIGB), the Center for the Production of Laboratory Animals (CENPALAB), the National Center for Biopreparations (BIOCEN), the Center of Immunoassay and the Center for Molecular Immunology (CIM).

What are the medications, made in Cuba, with the most international prestige? PanamericanWorld proposes to approach five creations, unique in the world, born of the brilliance and long years of research by Cuban scientists.

HEBERPROT-P: THE BEST TREATMENT FOR DIABETIC FOOT ULCERS

According to the World Health Organization, some 300 million people suffer from diabetes, and of these, between 15% and 35% may suffer amputation of one of their extremities. The Cuban drug Heberprot-P, the only one of its kind in the world, has been able to reduce amputations by diabetic foot ulcer in Cuban patients more than four times. Born from the creative genius of a team of scientists, led by Dr. Jorge Berlanga, at the CIGB, the drug is used in more than 20 countries.The treatment includes injection into the affected area of he person and accelerates the healing process of the skin, so that the wound would be closed in a period of approximately three months.

VACCINE CIMAVAX-EGF: A HOPE AGAINST LUNG CANCER

The chances of survival for people diagnosed with lung cancer at an advanced stage are very low; However, with CIMAvax-EGF a new hope has appeared. This vaccine was created by researchers from the CIM who took 25 years to develop the product. The treatment slows down the growth of cancer cells and, therefore, prevents the disease from spreading throughout the body and thereby prolongs people’s lives. The scientists clarify that it is not a preventive vaccine, but therapeutic, although it has also been used in those with higher risks of suffering from the disease.

The CIM also developed the VAXIRA vaccine (known as Racotumomab) that works on a molecule found in all cancer cells. Scientists hope that, in the future, the drug may be effective against leukemia and other tumors that accompany lung, colon, prostate and breast cancers.

CIMAvax-EGF caught the attention of scientists from the Roswell Park Cancer Institute in New York who continue to evaluate the possibility of taking this medication to the United States, which would be a milestone, because the Washington Blockade has prevented access to Cuban inventions.

Policosanol (PPG): A Natural Product to Lower Cholesterol

This drug, made from the wax of sugar cane, is used mainly to lower cholesterol, although the product also has other applications, since its antiplatelet, anti-ischemic and antithrombotic effects have been demonstrated; In addition, some take the medication because they consider that it invigorates the male genital tract. The PPG, being natural, has few contraindications, unlike what happens with other drugs on the international market for cholesterol.

Venezuela is one of the biggest consumers of PPG and Cuba also markets it in Serbia, Slovakia and Spain, among other nations.

Va-Mengoc-BC: Very Effective Vaccine Against Meningococci B and C

During the 80s of the last century, Cuba suffered an outbreak of meningococcal disease. The scientists worked intensely to find a solution and the Finlay Institute of Havana created VA-MENGOC-BC, a bivalent vaccine composed of meningococcal B outer membrane vesicles and meningococcal C capsular polysaccharide. It is currently the only commercially available drug in the world that attacks meningococci B and C.

In Cuba, more than 60 million doses of the vaccine have already been applied. The drug has proven to be very effective and with a high safety profile, as recognized by the World Health Organization.

Neuroepo: A Medication to Slow the Progression of Alzheimer’s

Population aging is one of the biggest problems facing Cuba. Currently, Alzheimer’s is the sixth cause of death in the country, among people over 60 years of age and, by 2040, this disease could affect 2.7% of Cubans. Today, more than 35 million people in the world have Alzheimer’s and there is no medication that is able to cure or stop its progression. In this context, the CIM scientists created a drug, called NeuroEpo, that delays the expansion of this disease.

“It would be the first time it is used on people and we have to wait for the results. This compound does not prevent Alzheimer’s disease, nor does it eliminate it, but the preclinical results are encouraging in that it could help to change the course of the disease, that is, slow down the deterioration that the patient inevitably suffers. Alzheimer’s is a neurodegenerative disease without regression, she will move forward. What we want is to help delay this degenerative process and improve the quality of life of that person, and of the family, “acknowledged CIM researcher Leslie Pérez Ruiz.

Upcoming Creations

Cuban scientists are working on a clinical trial with Heberferon, which acts on renal carcinoma and in patients with malignant brain tumors;



CubaHeal Research Department

A new approach to medical education in Cuba is developing. The approach encompasses sweeping new and advanced methods while deepening effective educational methods. The objective of these changes is to achieve the following:

  1. Enhance the practical training and knowledge base in order to address the need of a diverse population by producing a generation competent doctors with a deep knowledge base and scope of obligations and responsibilities
  2. Produce, via extensive training an army of scientifically oriented and socially committed students

These two principals were the cornerstone in guiding the establishment of successful and innovative Cuban medical education system, at the Faculty of Medicine at the University of Havana was the first to adopt said reforms back in the 1960. In spite of the resistance to a universal public healthcare and national primary healthcare to the populous. Such reforms were a major positive contributor to extending medical services to the deprived rural areas of the island and addressed the urgent need of establishing a training program for hundreds of doctors and physicians prepared and committed to this new vision.

As an initial commitment, and in 1959, students in their final year of medical training program held a series of heated meetings in order to vote on these new moral principles. The end result was an overwhelming vote in support of a decision to send hundreds of volunteers to where they were most needed, hence the establishment of the “Cuban camp”.

The principled students at the University of Havana elevated their initiative to the Ministry of Public Health, which swiftly agreed to establish 318 new jobs to serve the mountains areas. This was the origin of the “Rural Medical Services” program which attributed to the involvement of hundreds of new graduates over the next decade and lay the groundwork for the laws that would establish community service as a requirement.

Historical milestones of the Republic of Cuba’s Medical Education

  • 1726: The first medical program was established in Cuba
  • 1728: The establishment of the University of Havana, including Faculty of Medicine
  • 1842: The University of Havana adopts a reformed medical curriculum with focus on scientific principles that involved the introduction of clinical medicine
  • 1919: The establishment of a six-year Flexnerian modeled program to govern the basic, preclinical and clinical sciences
  • 1942: The improvement of the Flexnerian modeled program to govern the individual patient care, which included a teaching hospital for students, interns and residents
  • 1956: The University of Havana was shut down as per General Batista’s orders
  • 1959: The Faculty of Medicine of the University is re-established with 23 professors
  • 1963: An Emergency program was introduced to address the urgent need of training medical teams to handle the shortfall in public health care
  • 1970: The creation of primary model and primary care; community-based integrated polyclinics programs
  • 1976: The supervision of medical education became one of the Republic of Cuba’s Ministry of Public Health duties.
  • 1976: The Higher Institutes of Medical Sciences in Havana, Santa Clara and Santiago de Cuba was established
  • 1980: The establishment of 54 medical schools offering various medical specializations and covered all Cuban provinces
  • 1982: The strengthening of the selection criteria of medical students include vocational, motivational, as well as academic performance.
  • 1982 – 1985: Curricular reform for obtaining the Basic General Practitioner (BGP) for the family doctor program which offers more training in community based settings that emphasis on the medical school campus and hospital servicing
  • 1984: The family physician program was introduced
  • 1984: The creation of a comprehensive General/ Family Medicine program as a new medical specialty
  • 1986: The application of the first national practical and theoretical licensing examinations are applied with the utilization of external inspectors
  • 1996: The strengthening of the “Pillars of quality” assurance for medical education program, which resulted in stronger requirements for accreditation of established medical universities and centers.
  • 1996: The enforcement of the medical education credit system
  • 1997: The establishment of Master in Medical Education program
  • 1999: The establishment of the Latino Medical School (ELAM)


Advances of Cuban Orthopedics Mark Guidelines on the World

The advances of Cuban orthopedics has marked a guideline on the world medical scene and consolidated global reputation for their remarkable progress in research and application of novel techniques that placed the archipelago at the height of the most developed nations. So gave it a glimpse in Cuba Contemporánea Magazine the interview with the President of the Cuban Society of Orthopedics and Traumatology, doctor and Professor Rodrigo Álvarez Cambras, who highlighted the successes experienced by the island in this field.

Among the most outstanding initiatives of this medical specialty in the country which is at the forefront of the use of external fixators to treat various types of injuries and bone disease, said the eminent physician. Precisely, the doctor Álvarez Cambras is a recognized authority on this issue as the creator of the external fixator RALCA, currently patented in 24 countries. This orthopedic innovation which devised and developed four decades after first confirming its usefulness in experiments with laboratory animals, went on to be used for the first time in humans in 1974. Since then, more than 250,000 patients in Cuba have been favored with these excellent results with external fixators, expressed Álvarez Cambras.

In this sense, these fasteners are used in the treatment of multiple ailment fractures, tumors, and bone infections even for the elongation of the arms and legs, against the dwarfism, congenital deformities and traumatic contraction.

However, Cuba advances in orthopedics are within reach not only of all Cubans, but also patients from other latitudes, said Alvarez Cambras to refer, for example, the case of own external fixators, used in close to half a hundred nations. They are used in almost all of Latin America; in UnitedStates, Canada, France, Spain and Arab and African countries, recognized the also general director of the prestigious International Orthopedic and Scientific Complex Frank Pais.

According to Alvarez Cambras’s opinion, one of the most important management of external fixators is evident in situations of natural disasters or wars, events where – he said – almost 85% of the people affected tend to cater for orthopedics. In this regard, he recalled the use of those fixers in conflicts such as the arisen between Iran and Iraq in the Decade of the eighties or before natural disasters such as the earthquake of 7.6 degrees on the Richter scale that struck Pakistan in October 2005 and which caused more than 73 thousand dead. There, Cuban doctors saved thousands of lives and avoided a high number of amputations of a member due to these devices, said Alvarez Cambras to commemorate the work of more than 2,000 physicians sent by the island, and during eight months attended nearly two million people in this Asian nation.

Equally, the leading Professor emphasized the international cooperation that keeps Cuba in about 22 countries, with the presence of some 250 specialists. He reported which is today boasts more than a thousand and two hundred as a result of the development of this medical specialty in the Caribbean nation in the field of Orthopedics and about 400 in orthopedics training.

In addition to the above, the Republic of Cuba has also pioneered the following orthopidic surgical procedure:

  • Angular deformity of knee
  • Arthroplasty of non-cemented hip
  • Arthroplasty of unilateral knee
  • Hallux Valgus
  • Meniscus Chondromalacia Synovitis Lesions


CubaHeal Research

At the National Extension Workshop conference carried on September 27th, 2017 in the province of Camagüey, doctors from the provinces of Cienfuegos and Sancti Spíritus presented their evidence and application results on the effectiveness of the use of Heberferon for the treatment of Gorlin Syndrome.

Heberferon

Gorlin Syndrome, also known as Nevoid Basal-Cell Carcinoma Syndrome (NBCCS) is an inherited medical condition and a genetic disease involving flaws within multiple body systems such as the skin, eyes, bones, nervous system, and endocrine system and which could lead to the appearances of multiple Basal Cell Carcinoma (BCC). In spite of the fact its occurrence is rare, Gorlin syndrome causes extensive deterioration in the quality of life. Gorlin Syndrome conditions usually proceed multiple basal cell lesions.

In his presentation, Dr. Damaris Díaz Leonard, from Cienfuegos, discussed the medical case of a patient suffering from about 200 carcinomas throughout his body, and who has undergone various surgical procedurein the face region which resulted in deformities.

Dr. Leonard was backed by his colleague, Dr. Yilian Castro Maricy who also presented three similar patients suffering from Gorlin Syndrome. In his presentation, Dr. Maricy of the Camilo Cienfuegos Hospital in Sancti Spíritus, offered evidence showing that the application and treatment of these patients utilizing Heberferon has resulted in either total recovery in some lesions and partial and stable recovery in others, as well as the elimination of the possibility of the appearance of new carcinomas.

About Heberferon

Heberferon is an alternative vital to reducing or avoiding recurrent surgical procedures while improving esthetics and quality of life for those suffering from the disease.

Its effectiveness is in its ability to regulate components of the Hedgehodsystem, which is a system that plays a part in embryonic development which, in patients suffering from the Gorlin Syndrome, leads to mutation and tumor production and triggers lesions spread over almost the majority of the skin area.




In short words


CubaHeal Medical is a global organization specialized in facilitating medical treatments, medical education, in addition to patient and student care in the Republic of Cuba. CubaHeal is a loyal supporter of the Republic of Cuba, the Cuban people, the Cuban revolution, and the Cuban revolutionary leadership.




Subscribe


Sign up for CUBAHEAL newsletter to receive all the news offers and discounts.





CUBAHEAL | All rights reserved | Developed and designed by Moustaide CO