BACH PHARMA
 
Platform Drug Monosodium Luminol GVT® Indications Oncology

Cancer is the general name for a group of more than 100 diseases in which cells in a part of the body begin to grow out of control. Although there are many kinds of cancer, they all start because abnormal cells grow out of control. Untreated cancers can cause serious illness and even death. Cancer is caused by both external factors (tobacco, infectious organisms, chemicals, and radiation) and internal factors (inherited mutations, hormones, immune conditions, and mutations that occur from metabolism). These causal factors may act together or in sequence to initiate or promote carcinogenesis. Ten or more years often pass between exposure to external factors and detectable cancer.

Cancer is treated with surgery, radiation, chemotherapy, hormone therapy, biological therapy, and targeted therapy. Half of all men and one-third of all women in the US will develop cancer during their lifetimes. Today, millions of people are living with cancer or have had cancer. The risk of developing most types of cancer can be reduced by changes in a person's lifestyle, for example, by quitting smoking, limiting time in the sun, being physically active, and eating a better diet. The sooner a cancer is found and treated, the better the chances are for living for many years.

According to World Health Organization (WHO) statistics, there were 7.6 million deaths caused by cancer worldwide in 2008 (13% of all deaths), and with the largest proportion (1.4 million) due to lung cancer, followed by stomach, liver and colorectal cancers. WHO predicts more than 20 million new cases of cancer in 2025; deaths worldwide are projected to continue to rise to over 11 million in 2030. More than 30% of cancer deaths can be prevented and the therapeutic and commercial importance of this disease is rising.

The therapeutic goal for Monosodium Luminol GVT® in the treatment of various cancers is to provide adjunct treatments that strengthen the patient's immune modulating pathways to reduce complications before, during and after surgery by preventing operational infections, reducing the side effects caused by chemotherapy and radiation treatments, and promoting faster recovery and better quality of life.

The target indication for Monosodium Luminol GVT® includes bladder, colon, liver, lung and stomach cancers, which have already shown beneficial results in clinical trials and which all share common inflammation and oxidative stress factors which are all highly responsive to the immunomodulatory effects of Monosodium Luminol GVT®.

Clinical Results
Monosodium Luminol GVT® has been studied in clinical trials for treatment in patients with various types of cancer. This sample of completed studies demonstrates the efficacy of therapy using Monosodium Luminol GVT®:

Study Name Location Investigator/Author
Clinical and Immunological Effects of Immunomodulator Galavit in Patients with Advanced Lung Cancer of Stages II-III During Post-surgical Period. (2009) Moscow State University of Medicine and Dentistry; Central Clinical Hospital of the Ministry of Railway, Communications No2 Velsher LZ, Gabuniya ZR, Grishina TI, Germanov AB, Korobkova LI, Platonov DA, Gorchak UU, Argun BM, Shepelyaev DO, Gens GP
Perioperative Immunocorrection using Galavit Therapy in Cancer Patients (2007) Russian Cancer Research Center (RCRC), NN Blokhin, Moscow Sviridov SP, Kadagidze ZG, Blindar VN, Sytov AV, Nekhaev IV, Nikolaev EV
Evaluation of Galavit in Complex Treatment of Surgical Patients with Gastric Cancer (2006) RNTSH Russian Academy of Medical Sciences (RAMS), Moscow Russia Vinnitsa LI, Buniatian KA, Chernousov FA, Khorobrikh T, Inviyaeva EV
Immunomodulating Effects of Galavit in the Treatment of Patients with Bladder Cancer (2006) Russia Scientific Center of Radiology MZSR RF Kharchenko VP, Kaprin AD, Ivanov SA, Klimenko AA

Commercial Potential for GVT®
Large US and Global Market
  • It is reported that 1,596,670 new cancer cases are expected to be diagnosed in 2011 in the US. This estimate does not include carcinoma in situ (noninvasive cancer) of any site except urinary bladder, and does not include basal and squamous cell skin cancers, which are not required to be reported to cancer registries.
  • In 2011, about 571,950 Americans are expected to die of cancer, more than 1,500 people a day. Cancer is the second most common cause of death in the US, exceeded only by heart disease. In the US, cancer accounts for nearly 1 of every 4 deaths.
  • The National Institutes of Health estimates overall costs of cancer in 2010 at $263.8 billion: $102.8 billion for direct medical costs (total of all health expenditures); $20.9 billion for indirect morbidity costs (cost of lost productivity due to illness); and $140.1 billion for indirect mortality costs (cost of lost productivity due to premature death)
  • According to IMS Health (IMS), the current annual global market for cancer drugs is in excess of $75 Billion. It is projected to reach $100 Billion by 2020 as safer and more effective treatments are introduced.
Unmet Needs Remain:
In spite of increased investigations, research and collaborations funded by many pharmaceutical companies, foundations and government agencies, cures for cancer remain elusive. Novel compounds and therapeutics, that are safe and non-toxic to humans, are needed to fight the ever-increasing cases of cancerous diseases plaguing global populations in the escalating battle against insults from the environment as well as the human body’s own self-destructive mechanisms.


Indications Oncology Cancer Clinical Studies
Bach’s Monosodium Luminol products have been widely used for many years in complex treatments of many types of cancer therapies including advanced stages.

Select Monosodium Luminol Clinical Studies in Cancer
  • The use of Monosodium Luminol in the complex treatment of invasive bladder cancer
  • Effectiveness of Monosodium Luminol in the complex treatment of patients with gastric cancer
  • Clinical and immunological effects of immunomodulator Monosodium Luminol in patients with advanced lung cancer of stages II-III during post-surgical period
  • Monosodium Luminol with chemotherapy in breast cancer patients
  • Monosodium Luminol treatment in patients with lung cancer
  • Monosodium Luminol in treatment of kidney cancer
  • Monosodium Luminol in patients with abdominal tumors
  • Immunological correction of patients with colorectal cancer after treating with Monosodium Luminol
  • Immunology and biotherapy of malignant tumors
  • Perioperative immunocorrection with Monosodium Luminol in cancer patients
Indications Oncology Adjunct to Chemotherapy
Bach’s Monosodium Luminol products have been widely used in approved countries for many years in conjunction with standard cancer therapies to help the patient withstand the side effects and immune deficiencies caused by those treatments.

Adjunct to Chemotherapy
  • Monosodium Luminol causes a reduction in side effects associated with radiotherapy and chemotherapy
    • Nausea
    • Vomiting
    • Diarrhea
    • Immunological activity (increases the level of immunoglobulins and normalizes affinity of antibodies)
  • Immunological activity (increase the level of immunoglobulins and normalizes affintity of antibodies)
  • Designed to be used in conjunction with the main agents of therapy
Indications Oncology Cancer Therapy
Bach’s Monosodium Luminol products have been widely used in approved countries for many years in conjunction with standard cancer therapies to help the patient withstand the side effects and immune deficiencies caused by those treatments.

UNIQUE THERAPEUTIC BENEFITS
  • Studies have shown high clinical efficacy and safety for Monosodium Luminol as the standard care for patients with select cancer tumors, and as a secondary therapy for treating many types of cancer tumors
  • Improves portability of chemotherapy, reducing the frequency of nausea and vomiting
  • Improves the safety and toxicity profile, consequently improving the general condition and quality of life of patients
  • Contributes correction indicators for the immune system
  • Promotes normalization of the blood picture
  • Reduces postoperative infectous complications and the number of patient bed-days