Galavit

Abstract

This information is compiled by the Anticancer Fund and is based on the professional information. Last Updated: August 2016.

 

Galavit is a Russian drug that has been marketed as an anti-cancer agent since 1997. The alleged anti-cancer effects of Galavit have not been examined in any experimental or clinical study. There is currently no data on the efficacy of Galavit for the treatment of cancer.

What is it?

Galavit is a Russian drug that contains substances very similar to luminol, a chemical that gives off light in a chemical reaction (used to trace blood by forensic investigators). The exact content and chemical composition of Galavit has not been confirmed. Galavit was initially marketed as a secret discovery made by the Russian military to protect astronauts from radiation in space.

Does it work?

Experimental studies

One Russian study published in 2002 that examined the effects of Galavit on mice infected with bacteria, showed that animals treated with Galavit exhibited significant improvements and increased survival when compared to control animals. The supposed anti-cancer effects of Galavit have not been examined in any experimental study.

 

Clinical studies

Only two clinical trials with Galavit have been conducted on non-cancer patients and these were published in Russian journals. The first study evaluated the effects of Galavit on treating narrowing of the airway (trachea), and the second evaluated the effects of Galavit on treating circulation disorders in chronic gastric erosion. Both studies found that Galavit showed significant benefits, but these findings have not been independently confirmed by researchers elsewhere. The supposed anti-cancer effects of Galavit have not been examined in any clinical study.
 

Is it safe?

No independent evaluation of the safety of Galavit has been published. Information below is given by the provider.

 

Contraindications

Pregnancy, patients with idiosyncrasy (genetically determined abnormal reaction to a drug) to luminol.

 

Adverse effects

Galavit may trigger hypersensitivity reactions.

 

Interactions

No data available.
 

More info

How to use Galavit?
 
Galavit is supplied as a dry, yellowish-white powder that is dissolved in a 3ml saline solution for injection into muscle (intramuscular injection).
 
 
Prevalence of use
 
No data available
 
 
Mechanisms of action
 
The mechanisms by which Galavit has anti-cancer or anti-inflammatory effects are unknown. It is believed that Galavit is able to modify the immune response to decrease inflammation. Although there have been a few studies that have examined the effects of Galavit, none of these have been published in international peer-reviewed journals.
 
 
Claims of efficacy
 
It is claimed that Galavit is an anti-inflammatory drug that can be used for the treatment of inflammatory and autoimmune diseases, and as an anti-cancer drug that can be used before, during and after surgery, chemotherapy and radiation therapy. It has been claimed that Galavit has been used to treat 300 cosmonauts and 30,000 cancer patients.

 

Costs and expenditures
 
According to the provider, a single treatment of Galavit, consisting of 20 injections for 51 days, costs 1,477 euro.
 
 
Legal issues
 
Galavit has been registered in the Russian Federation since 1997. There are distributors in some parts of the EU and US. Galavit can be purchased online.
 

Abstract

This information was compiled and reviewed by the CAM-Cancer consortium. Last Updated: August 2016.

 

No data with regards to Galavit’s efficacy as a cancer treatment and no independent safety evaluation of Galavit are available.

Galavit contains as a chemically active substance Monosodium 5-Amino-2-3-Dihydro-1-4-Phthalazine Dione. Galavit is claimed to have an immunomodulatory effect on malignant tumours. So far the substance has shown some immunomodulatory effects in one animal experiment and in two human trials in non-cancer patients. No data are available with regards to Galavit efficacy as a cancer treatment.

What is it?

The main chemically active substance in Galavit is Monosodium 5-Amino-2-3-Dihydro-1-4-Phthalazine Dione (1). In some publications the name is given differently: 2-Amino-2,3-dihydrophtalazine-1,4-dione sodium salt 2 or 5-Amino-1,2,3,4-tetrahydrophthalazine-1,4-dione sodium salt (3) or 2-Amino-1,2,3,4-tetrahydrophthalazine-1,4-dione sodium salt (4,5). Some authors argue that if the main substance of Galavit is Amino- tetrahydrophthalazine, then it would be close to the substance luminol which is know from luminescence (3,6). Indeed the empirical formula of Galavit and Luminol are the same. However, it is not clear whether the different names refer to different products (3). Some authors do not mention in their publication the exact chemical name of Galavit (7,8).

Ingredients

Galavit is a dry, yellowish-white powder delivered via an injection vial containing 100mg of Monosodium 5-Amino-2-3-Dihydro-1-4-Phthalazine Dione (C8H7N3O2) dissolved in 3ml saline solution. It is to be injected slowly (15 min) intramuscular (1).

History / provider

Galavit is registered and manufactured in Russia. It is reported to have been developed by the Russian military to protect astronauts from radiation in space. In 1997 Galavit was registered in the Russian federation by the ministry of health (9). Some sources even state that the substance would has been used by 300 cosmonauts and 30,000 cancer patients (4,10).

Claims of efficacy / mechanisms of action / alleged indication

According to the distributor, Galavit is registered in Russia as an anti-inflammatory and immunomodulatory drug for the treatment of inflammatory diseases, immunodeficiency and autoimmune diseases, as well as for the immunomodulatory treatment of malignant tumours, before, during and after surgery, radiation and chemotherapy (1).

The mechanisms of action of Galavit as an immunomodulatory substance are linked to the elevation of T-helper (CD4+) and natural killer cells (CD16+) in non cancer patients and of interleukin-1 (IL-1) and tumour necrosis factor (TNF) in mice (11). In 2002 Vel’sher et al reported on abstracts of clinical examinations of Galavit given during several conferences in Russia. None of these are published in peer-reviewed journals (1).

Both the dosage and duration of the intramuscular injection of Galavit depend – according to the producer – on the type of disease. The Galvit brochure states that a tolerable and effective “complementary therapy for cancer” would be: daily injections for the first five days, followed by injections every third day until 20 injections have been administered (1). The course can be repeated.

Prevalence of use

No data have been published regarding the prevalence of the use of Galavit by cancer patients.

Legal issues

Galavit has been registered in the Russian Federation since 1997 (Monosodium 2-Amino-1,2,3,4-tetrahydrophtalazine-1,4-dione) (6,9). There are some distributors in the EU and US. The substance can be ordered via internet in addition.

Costs and expenditures

The price for a treatment consisting of 20 injections for 51 day's treatment is 1.477,00 Euros according to provider.

Does it work?

Clinical trials

Two clinical trials with Galavit have been conducted on non-cancer patients and published in Russian. For this summary only their English abstracts could be used. Larina et al examined the immune status of 28 patients with cicatricial stenosis of the trachea (12). Galavit given pre- and postoperatively increased the level of T-helper (CD4+) and natural killer cells (CD16+) and induced the phagocyte activity of neutrophils.

Maev et al examined microcirculatory disturbances with Doppler laser flowmetry in 95 patients with chronic gastric erosions (CGE) (13). Treatment of the erosions with triad therapy eradicated the erosions in 80%. Additional therapy with Galavit showed a more effective restoration of the blood flow.

Pre-clinical studies

One pre-clinical study (11) with albino mice (10 verum, 10 control) examined the effect of Galavit (8 mg/kg injected intramuscularly from day four of disease) on interleukin-1 (IL-1) and tumour necrosis factor (TNF) production after infective doses of two types of rickettsial infection via intraperioneal infection. In animals infected with spotted fever, clinical manifestation was reduced by two days and clinical signs were less pronounced and absent in 20% of them. In animals infected with scrub typhus the clinical manifestation was reduced in addition, and mortality was reduced by 50%. In both groups IL-1 and TNF were decreased.

Is it safe?

No independent safety evaluation of Galavit has been published (14). Information given below are statements made by the provider.

Contraindications

Pregnancy, idiosyncrasy against the active substance (1).

Precautions / warnings

None stated (1).

Adverse effects

In very rare cases there may be idiosyncratic (allergic) reactions, which will disappear as soon as Galavit is discontinued (1).

Interactions

None are known (1).

Quality issues

There are no independent assessments of the quality of Galavit.

References

  1. Pharma [homepage on the internet]. 2004 [cited 25.07]. Medisan Pharmaceuticals Ltd. Galavit Documents. Galavit Brochure. Scientific Information. Available from: http://www.galavit.com/
  2. Deutsche-Gesellschaft-für-Hämatologie-und-Onkologie [homepage on the internet]. 2001 [cited 25.07]. Deutsche-Gesellschaft-für Hämatologie-und-Onkologie. Krebstherapie mit Galavit. Available from: http://www.dgho.de/aktuell/galavit.htm
  3. Heber D [homepage on the internet]. 2001 [cited 25.07.2005]. arznei-telegramm. Galavit = Luminol? Available from: http://www.arznei-telegramm.de/zeit/0101c.php3
  4. Anonymous. Galavit gegen Krebs. Russisches 'Wundermittel' aus der Weltraumforschung. Deutsche Apotherkerzeitung 2000; 140: 51-52.
  5. Winter D. Galavit. In: Münstedt K, editor. Ratgeber unkonventionelle Krebstherapien. Landsberg: ecomed Medizin; 2005. p. 247-249.
  6. Buerger-Forum [homepage on the internet]. 2001 [cited 25.07.]. Galavit: zwielichtige Geschäfte, gefährliche Experimente. Available from: http://www.verbrauchernews.de/artikel/0000007183.html
  7. Galavit. In: Josef B, editor. Grundlagen der Komplementäronkologie. Theorie und Praxis. Stuttgart: Hippokrates; 2002. p. 300-301.
  8. Irmey G, Jordan A-L, Norton R. 110 wirksame Behandlungsmöglichkeiten bei Krebs. Heidelberg: Haug; 2001.
  9. Arzneimittelkommission-der-deutschen-Ärzteschaft. Zur Anwendung des Präparates "Galavit" in der Krebstherapie. Dtsch Arztebl 2001; 98: A 1016.
  10. SKAK [homepage on the internet]. 2001 [cited 10.11.2005]. Krebsliga Schweiz. Galavit "Krebsimmuntherapie". Available from: http://www.swisscancer.ch/dt_fr/content/orange/pdf/skak/01_03_galavit_d.pdf
  11. Nelyubov MV. Cytokins in the pathogenesis of astrakhan spotted fever and North Asian scrub typhus: problems of immunocorrection. Bull Exp Biol Med 2002; 134: 165-7.
  12. Larina TV, Bondarenko AV, Bogomolova NS, Vinnitsky LI, Bunyatyan KA, Nikoda VV. [The immune status and its correction in patients after reconstructive surgeries for cicatricial stenosis of trachea]. Anesteziol Reanimatol 2004: 83-5.
  13. Maev IV, Kaziulin AN, Kucheriavyi Iu A, Gadzhieva MG. [Microcirculatory disorders in chronic erosions of the stomach]. Klin Med (Mosk) 2003; 81: 37-42
  14. Jellin J, Gregory P, Batz F, Hitchens K. Pharmacist's letter / prescriber's letter natural medicines comprehensive database

Galavit