Galavit

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.

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.

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.