Platform Drug Monosodium Luminol
GVT® Origins and Development
Monosodium Luminol GVT® has a long background history in Russia. Monosodium Luminol was originally used by the Russian Soviet astronauts in the 1960’s space program and then by the Russian Soviet army for radiation protection and wound care during the 1980’s war in Afghanistan. Monosodium Luminol was also historically used in Russia as an adjunct therapy to treat cancer patients and it proved to be effective. Monosodium Luminol is now being widely used for treatment in the Women’s Healthcare and Gynecological market in the Russian Federation.
In 2002 Bach Pharma acquired the non-Russian worldwide
marketing and distribution rights to Monosodium Luminol
from The Center of Modern Medicine (MEDICOR) of Moscow. Bach and MEDICOR
shifted the manufacturing process to the United Kingdom in 2006 after
the Bach developed the active pharmaceutical ingredient (API) for its
platform drug Monosodium Luminol GVT®. Using Bach’s patented
FDA approved manufacturing processes in FDA approved facilities resulted
in a much enhanced and purified API product.
Recently a search for therapeutic treatments for specific cancer indications has been escalated in the Russian Federation. Monosodium Luminol products, already registered as treatments for specific cancer indications, are now being sought in the Russian Federation for purchase through soon to be contracted distribution partners.
Bach and MEDICOR intend to obtain regulatory approval in Russia to substitute GVT® for MSL®. Bach will further develop products based on its GVT® drug platform technology for marketing and distribution through established marketing and distribution networks via contractual arrangements such as joint venture, licensing, distribution or similar collaborative agreements. Bach and MEDICOR are currently seeking commercial partners to actively market GVT® in the Russian Federation and select Commonwealth of Independent States (CIS) and Central and Eastern European Countries (CEE). The principal markets for the potential pharmaceutical and healthcare products include hospitals, medical offices, dental offices, dialysis centers, outpatient clinics, emergency response centers and nursing homes.
Platform Drug Characteristics
Monosodium Luminol GVT® and its derivatives
have unique properties:
- A redox buffering molecule
- Small molecule with a molecular weight of 199.14 g/mol
- Novel cytoprotective agent; chemically active substance monosodium 5-amino-2-3-dihydro-1-4-phthalazine dione
- Has the ability to enter cells of the central nervous system and immune system, thereby delivering therapeutic results to the gut, thymus, spleen and blood
- Has the ability to cross the blood-brain barrier and retinal-brain barrier
- Anti-oxidant and anti-inflammatory properties as it scavenges free radicals
Characteristics
Platform Drug Mechanism of Action
Bach’s researchers have discovered the Mechanism of Action of its drug platform Monosodium Luminol GVT®.
Data from published studies shows that GVT®:
- Regulates the activity of macrophages and synthesis of pro-inflammatory (IL-1, IL-6, TNF-alpha) and anti-inflammatory (IL-10) cytokines
- Increases the level of immunoglobulins (IgM, IgA) in their failure, normalizes affinity immunoglobulin
- Regulates the proliferative activity of subpopulations of T lymphocytes (T helper, T-killers)
- Regulates the cytotoxic activity of NK cells
- Has a stimulating effect on the phagocytic activity of neutrophils during its initial deficit
- Regulates the synthesis of interferon alpha and gamma
- Has antioxidant effect
- Regulates the repair of damaged tissue
- Regulates Nrf2 with increased production of glutathione (GSH) and thioredoxin
Mechanism of Action
Platform Drug Effects
Monosodium Luminol GVT® has powerful effects on multiple pathways and networks:
- Restores mitochondrial membrane potential when mitochondria is under stress, and also prevents mitochondrial-induced cell death
- Relatively non-toxic, well absorbed, can be taken orally, rapidly excreted, can get into the brain by passing through the blood brain barrier
- Prevents oxidative stress, both by scavenging free radicals and by regulating Nrf2 with increased production of glutathione (GSH) and thioredoxin
- Reacts with peroxinitrite thereby preventing protein nitration and oxidation in microglia and preventing microglia-induced neuronal damage
- An iron and other heavy metal chelator and thereby prevents iron-catalyzed oxidative damage
- Decreases intracellular reactive oxygen species (ROS) levels in astrocytes and other cell types under various stress conditions
Drug Effects
Platform Drug PK & Advantages
The Monosodium Luminol GVT® drug platform is available for use in many methods of application, has a proven safety record in humans, and is beneficial for use in adjunctive therapeutic treatments.
PK & Advantages
Platform Drug Manufacturing
Bach has established proprietary manufacturing and commercialization capabilities in anticipation of the worldwide licensing and partnering developments of its Monosodium Luminol GVT® drug platform.
- Bach’s GVT® is being manufactured in the UK to allow for compliance with cGMP and GLP requirements
- Bach has a patented 3-step GMP-manufacturing process
- Bach has an exclusive arrangement with SAFC Pharmaceuticals (a wholly owned subsidiary of Sigma Aldrich) to manufacture GVT®
- Bach retains all IP and product processing technology rights and has an exclusive manufacturing license with SAFC Pharmaceuticals
- Bach is able to scale-up to produce commercial batch sizes
Manufacturing
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