22/03/2018
VIDATOX
General Information
INTRODUCTION
The application of scorpion venom in antitumor therapy stems from research carried out by Debin et al. in 1991, in which he first demonstrated that Leirus quinquestriatus scorpion venom possessed antitumor activity and inhibited the migration of gliomas. Later this same activity was demonstrated for the species Bhutus martensii Karsh, although in murine models. Similarly the use of scorpion venom Euscorpius italicus Herbst, has been referenced in the Homeopathic Pharmacopoeia of Willmar Schwabe.
In Cuba scorpion venom Rhopalurus junceus, endemic species, has been used for medicinal purposes since the early nineteenth century. As such, researchers LABIOFAM Business Group showed that the total scorpion venom Rhopalurus junceus as molecular mass fractions of less than 5 kDa have significant toxicity on tumor cells of epithelial origin. The Vidatox® is a biotherapy whose active principle scorpion venom Rhopalurus junceus 30 centesimal dilution. It is a non toxic product by mouth. Its use does not exclude or limit other conventional cancer treatment, however, their use simultaneous may have synergistic or potentiating effect on the antitumor activity of conventional cancer treatment. A field of application of biotherapic products are used in the adjuvant treatment of neoplasms, because at present there are no treatments to be fully effective. Biotherapic within specific products in cancer therapy can cite two widely used Carsimosín (pool of tumor cell macerated stomach, intestine, lung, colon, bladder) and Schirrhinum (pool of tumor cell macerated liver and intestine), both well used and cited in the literature.
In this context the preparation of pure Vidatox® from scorpion venom Rhopalurus junceus is presented as a complementary option to combat this disease.
DEFINITIONS.
Biotherapic: the drugs are prepared and biotherapic obtained from products of microbial origin and pathological secretions or excretions or of animal origin, chemically undefined.
ADMINISTRATIVE INFORMATION.
1. General Information producer.
Grupo Empresarial LABIOFAM
Independence Ave Boyeros Km 16 ½ C. Havana.
Phone: 683 0391 Fax: 683 0326
Email: [email protected], [email protected]
2. Overview of the finished product
2.1 Trade name of the drug
Vidatox®
2.2 Route (s) of administration
Sublingual
2.3 Presentation
Amber glass bottles 30 mL screw cap and retapa-dropper.
Each bottle (30 mL) containing 120 doses, with its prospectus, individual box.
Multi pack of 12 units.
2.4 Clinical Information
2.4.1 Therapeutic indications
Is recommended as an adjunct in the treatment of neoplastic diseases.
2.4.2 Dosage and Administration
5 drops sublingual every 12 hours.
If the patient does not tolerate direct medication in your mouth for the alcoholic who preserves and / or injuries digestive tract, or have the closed mouth is suggested: add 15 mL (1 tbsp) of boiled water or purified 5 drops of medication, shake circular with plastic spoon for 1 minute. Manage this solution every 12 hours.
It can be supplied the drug via gavage.
2.4.3 Contraindications
None known.
2.4.4 Warnings
There have been described.
2.4.5 Precautions
Do not administer with strong odors, foods or beverages. It is recommended, no smoking, drinking or eating 20 minutes before and after administration.Keep away from electronic equipment generating strong electromagnetic waves.
2.4.6 Interactions with other medicinal products and other forms of interaction
none
2.4.7 Use in pregnancy, lactation and children
Is not suggested to use in pregnant women and children under 1 year .
2.4.8 Effects on ability to drive vehicles and use equipment
There have not been described.
2.4.9 Adverse Reactions
None known.
2.4.10 poisoning, symptoms, emergency treatment and antidotes
There have not been described.
2.5 Instructions for use
The remote administration of meals, drinks and strong odors recommended; so you should not eat, drink or brush your teeth or smoke 20 minutes before and after administration.
2.6 Shelf
Five years provided storage requirements are met.
2.7 Storage Conditions
Store in a cool, dry place. Protect from the incidence of direct sunlight. Keep away from equipment generating electromagnetic fields (TVs, radios, refrigerators, microwave ovens, computers, cell phones, etc.).
3 INFORMATION preclinical
3.1 Pharmacological Evaluation
There are up to now a significant body of experimental results of pharmacological activity in a variety of preclinical models that confirm the great potential of the Cuban scorpion venom as an adjunct in the treatment of neoplastic diseases as summarized below:
3.2 Evaluation of antitumor activity
Poison antitumor capacity, was evaluated in a mouse mammary adenocarcinoma model. The results showed that administration of the extract, by orally or intraperitoneally, caused a significant decrease in dose-dependent tumor progression. Similarly poison administration in animals with lung metastasis significantly decreased the frequency of occurrence and in the lungs. The results in experimental models with implanted tumors in vivo evidence that both routes of administration the venom is able to significantly reduce lung tumor progression and metastasis.
3.3 Study drug combination
Poison combination with conventional antineoplastic drugs (cyclophosphamide, 5-fluorouracil, cisplatin) was evaluated in a human lung tumor line and in vivo models. The presence of scorpion venom in combination, enables lower concentrations and times shorter exposure of antineoplastic drugs rates significantly higher growth inhibition compared to simple treatment are achieved. Additionally poison is capable of acting synergistically potentiating the effect of antineoplastic.
3.4 Study of pharmacokinetics and biodistribution
The biodistribution for 24 hours in healthy animals, intravenously, showed that the poison is rapidly distributed from the central compartment (blood) to the peripheral (tissue) showing a high affinity for these. Orally poison had a plateau-shaped behavior in the analyzed organs, while its presence in the lungs was much less marked than through IV, however the behavior was up until 8am and superior to other organs. This result shows that by both routes lung represent the target organ and suggests high bioavailability and sustained poison with respect to the other bodies. These results correspond with the differential sensitivity of the extract to the lung tumor cell lines in vitro observed in experimental models and the lungs marked antimetastatic activity in in vivo experimental models.
3.5 Model of inflammatory angiogenesis
Proceeded according to the technique described by Kobayashi et al. (1998) and the tested doses of 3 and 5 mg / kg intraperitoneally for a statistically significant reduction to the weight of the granulomas formed for both tested doses relative to the control group. The carmine content is also (as an indicator of vascularization) in samples granulomas treated animals venom doses were lower than in samples from the control group, showing an antiangiogenic for this product.
4-Evaluation of toxicological safety
Toxicological safety of scorpion venom was evaluated Rhopalurus junceus demonstrating the non-toxicity of the product through the tests detailed in numerous international guidelines, as summarized below:
4.1 Acute Toxicity Oral (OECD 423). No lethality or changes in behavior reported body weight and signs of delayed toxicity in experimental animals tested, even at the highest dose tested (2000 mg / kg) allowing locate the product in toxicological category "Uncategorized" (LD50> 2000 mg / kg):
4.2 Toxicological study for 28 days. In the study of repeated dose for 28 days orally in mice scorpion venom Rhopalurus junceus at a dose of 100 mg / kg, no toxic signs or mortality caused by the administration of the test substance or alterations in the parameters were observed haematological and biochemical
4.3 subchronic toxicological study for 90 days. In the subchronic study for 90 days orally in mice at doses up to 100 mg / kg, no toxic signs or mortality, haematological and biochemical changes were observed neither. The relative organ weight was unaffected and histopathological analysis showed no abnormalities in organs and tissues following the administration of the test substance.
4.4 Irritability acute and chronic oral mucosa. The poison is not irritating to the oral mucosa when applied acutely and chronically.
4.5 Genotoxicity. Micronucleus assay was used in mouse bone marrow observed that the poison when administered orally is not cytotoxic or genotoxic.
5 INFORMATION CLINIC
To evaluate the adjuvant effect of Vidatox® in cancer treatment A retrospective study of 174 cancer patients of both sexes with confirmatory histopathological diagnosis, which were administered 5 sublingual drops every 12 hours during the period 3/12 was done / 2007 to 2/2/2010. Upon completion of this period was identified that tumors of lung, prostate, colon, breast and uterus were the most sensitive to the effect of the product. Similarly showed that 96% of patients had a survival of 12 months, 90% reported improvement of clinical symptoms causes, and that the pain in 62% of cases evolved into a form moderate not necessarily require treatment for relief and that 27% reported no pain. We conclude that the use of Vidatox® be used as adjunctive therapy in the treatment of cancer.
