When cancer stands as the first cause of death in Cuba, the news that Labiofam has developed a formulation that only affects cell malignant tissue and not the healthy one, has generated an overwhelming expectation and claim for more information to be offered with detailed status of such research, it is clear that it we can’t talk of a ready-to-use drug yet, and perhaps for some time still.
According to statements the newspaper Juventud Rebelde, Jose Antonio Fraga, director of Pharmaceutical Biological Laboratories Company, “by treating nude mice (hairless lab mice) with maximum dose (of peptide RJLB14, extracted from the toxin of the red scorpion Rophalerus juencus) (five milligrams) are shown reductions of up to 90 percent of tumors in a period of 36 days. ”
The note adds that the findings were presented to the Board of the Ministry of Public Health, “with an endorsement containing evidence and trials”, a revelation that generates a number of questions, while is not clear on what type of cancer the formulation acts or identify the certified laboratories in Europe where, in the words of master degree in Microbiology and experimental Pharmacology Alexis Diaz, they would have been testing the product around.
During the scientific sessions of the two international conferences convened by Labiofam in 2010 and 2012, researchers Regla Maria Medina and Alexis Díaz himself presented detailed information on the design and synthesis of recombinant peptides, obtained from the Rophalorus junceus toxin and on tests with five of them in several tumor cell and normal cells in laboratory scale and in some animal models.
The results presented there showed that four of the peptides were able to markedly affect tumor cells, with a greater effect on cervical cancer, and lower against colon carcinoma.
With these and other data, scientists have defended the pharmacological potential of scorpion venom as antitumor and anti-metastatic in carcinomas, adeno-carcinomas, and solid tumors in general, at the same time ensure that the scorpion venom does not affect the immune system’s T lymphocytes, one of the undesirable effects in current anticancer drugs.
In that circumstance, Julian Alvarez, from the Coordinating Center for Clinical Trials of Cuba (CENCEC), explained the need for studies evaluating all possible forms of administration, dosage, etc.., to reach accurate conclusions on the different mechanisms of action, make a record that would allow human clinical trials.
That a formulation or protein works in the laboratory does not mean that they behave the same way in a complex organism like the human, with an immune system that can neutralize them, so the best advice in these preliminary result cases is prudence.
So far the public record of the National Coordinating Center for Clinical Trials (CENCEC) doesn’t register any test approved in humans with peptide RJLB 4 or any other derivative of scorpion as underway.
The available documentation only records two phase IV clinical trials for Vidatox 30 CH, a homeopathic product, highly contested, while much of the Cuban and international scientific community considers to homeopathy as a pseudoscience, as the preparations used, given its extreme dilution should not have any effectiveness beyond the placebo effect, a confirmed fact by most international studies to demonstrate its effectiveness.
A search of data on peptide RJLB14 in PubMed database did not show any information.
On the website of the World Intellectual Property Organization (WIPO), has been reported an application for patent made by Labiofam with publication dated April 2012, entitled venom peptides Rophalorus scorpion junceus and pharmaceutical composition, but so far it has not been granted. For Cuba there is also an application that has not been approved.
Patents do not have to prove scientifically attributed property. The patent describes features that are the responsibility of the owner and the granting of it does not involve scientific demonstration.
Labiofam application relates the identification of eight peptides derived from Rhopalurus junceus scorpion venom, and provides details of the proportion of active ingredients within the range venom and biological activity on tumor cells, related tests performed in vitro cytotoxicity tumor cell (human cervical carcinoma, larynx, lung and mammary adenocarcinoma, etc.), as well as the study of analgesic activity by different routes of administration and the ability to inhibit lung metastases from an experiment in mice.
Surprisingly, the reading of the patent revealed conducting a study on a hundred human patients with breast, prostate, colon, lung, brain and pancreas, among others, with the aim of evaluating their quality of life.
According to this analysis, which is not registered or approved by the CENCEC, after a year of use the product would not have caused adverse reactions and, apparently, “in all cases was observed (…) improvement of fundamental clinical variables were reduction or disappearance of dyspnea and cough in all cases of lung cancer patients. ”
Moreover, on many patients they have found an improvement in the stabilization of radiation injury, haematological variables and decreased pain and inflammation. In more than 50 percent of those treated for one year with the formula, it would have exceeded the estimated survival time for some of the diseases studied. “There is no information whether or not there was a control group.
The use of Rhopalurus junceus scorpion venom for therapeutic purposes dates back to the late 80s of last century, according to the Journal of Biomedical Research (2009, 28/1).
The toxin was used to create the Escozul handmade product, which generated much debate in the medical field that transcended to the rest of society. In 2009 the Ministry of Health had to issue an official statement clarifying that “their use for therapeutic purposes whatsoever, does not have the recognition and approval of CECMED (Center for State Control of Drugs, Medical Devices ) for medical use. ”
The same Journal of Biomedical Research showed in an article that the cytotoxic effect of the active principle present in the crude venom was dispelled after one month at temperatures of between four and 20 Celsius.
In the world there are becoming frequent investigations on such substances to targets in diseases such as cancer. A study in mice at the University of Washington, United States, published in the ACS Nano journal, explains the components of Leiurus quinquestriatu scorpion venom or “hunter of death”, as it is known for being one of the most poisonous in the world, could help gene therapy for the treatment of brain cancer.
Detailed research states that the chlorotoxin that the Leiurus stores coupled with iron oxide nanoparticles could duplicate gene expression in brain cancer cells, compared to the nanoparticles containing no chlorotoxin.
Cuba has a national cancer program that guarantees free access to all levels of health care, from a system of primary health care to detect early-stage disease and provide orderly and continuous monitoring.
The development of biotechnology for the development of pharmaceutical products of high added value has solidified this program. The scientific work of the Center of Molecular Immunology (CIM) within the business group BioCubaFarma , is just one example-but the more praiseworthy-of development of drugs and vaccines as biological therapy against different carcinomas.
After years of research, the Center of Molecular Immunology created two therapeutic vaccines against non-small cell lung cancer (the most common and deadly malignant tumors of that organ): the CIMAvax-EGF, recorded in 2008 by the Ministry of Public Health and the Racotumomab, presented in 2013.
Although they do not cure the disease, these vaccines shrink tumors thereby increasing life expectancy and quality of life.
The CIM also possesses in its portfolio of products the monoclonal antibody TheraCIM h-R3 (2002) and the Nimotuzumab, the latter to treat advanced brain and head and neck tumors, among other many formulations in various stages of trials, profile they work along the Center for Genetic Engineering and Biotechnology, immersed in the planning or execution of several clinical trials and approved by the CENCEC for products intended for brain tumors or other cancers.
The aim of these investigations is to achieve a wide range of therapeutic combinations, validated and secure, that will make of cancer a chronic disease, and give the afflicted more years of survival and quality of living.