Overview
The Company transferred drug-manufacturing technology to the United Kingdom in 2005, and developed a manufacturing process to scale up production of the product. Bach has made and continues to make qualitative improvements on its pharmaceutical properties, some of which include enhanced purity, from 95% to 99.8%, increased stability and increased solubility. Significant commercial scale-up hurdles have been overcome under GMP conditions and qualifications. Bach has an exclusive arrangement with SAFC Pharmaceuticals (Sigma Aldrich) to manufacture all of the Company’s active pharmaceutical ingredients.
The Company’s focus is on the development of this new drug platform’s unique attributes. Bach’s lead candidate GVT® is a novel cytoprotective agent. GVT® has powerful anti-oxidant and anti-inflammatory properties and scavenges free radicals. Research has shown that GVT® is a redox buffering molecule, a heavy metal chelator, as well as a regulator of proteostasis and Nrf2. GVT® has the ability to cross the blood-brain barrier and enter cells of the central nervous system, as well as to enter the immune system, thereby delivering therapeutic results to the gut, thymus, spleen and blood. It is also able to cross the retinal-brain barrier.
The safety of Bach’s compounds has been established by extensive human trials, as well as its use outside of the United States, that has proven non-toxic at various therapeutic doses. Many independently reviewed and published articles in scientific journals have reported results of studies using Bach’s compounds. These studies have linked pro-inflammatory responses, targeted by GVT®, to the amelioration of medically important health conditions and diseases. At therapeutic dose levels, GVT® exhibits no mutagenicity. GLP studies demonstrate the absence of lethal mutations in germinal cells as well as the absence of DNA alteration in differentiated cells. Evidence has also shown that these compounds are not teratogenic, allergenic or immunotoxic.
Current Research
The Company’s primary focus is for the utilization of GVT® and its derivatives for inflammatory conditions, oxidative stress (traumatic or genetic), and the related diseases they cause. Oxidative stress occurs in cells when the production of reactive oxygen species exceeds intracellular antioxidant defenses. Research results show oxidative stress is involved in many diseases involving neurodegeneration. Potential target indications include adjunct therapy for the treatment of neurodegenerative conditions including ataxia-telangiectasia, Alzheimer’s disease, amyotrophic lateral sclerosis, Friedreich’s ataxia, multiple sclerosis and Parkinson’s disease. Halting or slowing the progression of neurodegeneration in these diseases by Bach’s compounds will provide a significant commercial opportunity for the development of the use of these phthalazinedione compounds. Other areas of interest also affected by oxidative stress include ophthalmic diseases, trauma, healing and immune-deficiency syndromes. In this context, the company identified several serious rare diseases that qualify for orphan drug status and plans to continue to develop medical device technology for the treatment of edematous wounds.
The Company intends to file its initial investigational drug application (IND) as an adjunct therapeutic agent for use in the treatment of pediatric patients with ataxia-telangiectasia (A-T). A-T is a rare childhood neurological disorder caused by a gene deficiency. An institutional review board approval has already been obtained for the use of GVT® in a US clinical trial in A-T patients and the Company intends to commence the trials shortly. Bach is also in the final stages of the establishment of a program with Harvard Medical School and Children's Hospital Boston to conduct A-T clinical trials on a multi-university program throughout the US, and potentially in Europe.
Additional clinical trial protocols are currently in development and under review.
The safety of Monosodium Luminol based products has been clearly established
by successfully completed clinical trials and over 20+ years of use outside of
the United States. In addition, the original licensed compound has been registered
and approved for commercial human use and sale in seven European countries through
Bach Pharma, Inc.
Clinical supplies of the drug are currently available.
