What is Galavit?

The main chemically active substance in Galavit is Monosodium 5-Amino-2-3-Dihydro-1-4-Phthalazine Dione (ref 1). In some publications the name is given differently: 2-Amino-2,3-dihydrophtalazine-1,4-dione sodium salt (ref 2) or 5-Amino-1,2,3,4-tetrahydrophthalazine-1,4-dione sodium salt (ref 3) or 2-Amino-1,2,3,4-tetrahydrophthalazine-1,4-dione sodium salt (ref 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 (ref 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 (ref 3) Some authors do not mention in their publication the exact chemical name of Galavit (ref 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 (ref 1).

History / provider

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"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"

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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 (ref 9). Some sources even state that the substance would has been used by 300 cosmonauts and 30,000 cancer patients (ref 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 (ref 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 (ref 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 (ref 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 (ref 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) (ref 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.

References

1. Bach-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.