Tagged as a “silent epidemic” nearly a decade ago, Traumatic Brain Injury (TBI) is a leading cause of death and disability among a predominately young male population. Estimates run as high as 10 million cases of TBI per year worldwide. Annually, within the U.S., there are about 2 million emergency room visits for head injury, roughly 475,000 admissions for head trauma, nearly 52,000 deaths and approximately 80,000 cases of severe long-term disability.

In the U.S. alone, there are more than 5.3 million people living with TBI-related disabilities. The incidence of TBI far exceeds the annual incidence rates of Multiple Sclerosis, Parkinson’s Disease and Alzheimer’s Disease.

According to the National Institutes of Health, the economic consequences of TBI are enormous.  The annual cost of acute care and rehabilitation in the U.S. for new cases is estimated to be as high as $10 billion. A study by the National Foundation for the Brain estimated the annual cost in the U.S. for TBI at $48.3 billion.

The annual market potential for treating TBI in the U.S. is estimated to be over $500 million. The worldwide estimate for the treatment of TBI is estimated at $1 billion.  Currently there is no FDA approved product for the treatment of severe head injury.

A patient with TBI is defined as having had a traumatically induced physiological disruption of brain function often manifested by at least one of the following: Loss of consciousness, loss of memory for events immediately before or after the accident, any alteration in mental state at the time of the accident (i.e. feeling dazed, disoriented or confused), or focal neurological deficits that may or may not be transient.

TBI can be caused by a variety of factors, for example: The head being struck or striking something else, or the brain undergoing rapid acceleration or deceleration (i.e. whiplash) without direct external trauma to the head.

The highest incidence of TBI is among young people 15-24 years of age and among the elderly, 75 years of age or older. Children aged 5 years and younger also show a significant incidence of TBI.  Males are twice as likely as women to sustain TBI.

Motor vehicle, bicycle and pedestrian-vehicle accidents account for approximately 50 percent of the injuries.  Falls represent the second most frequent cause of TBI and violence related incidents account for about 20 percent of the cases.  Sports and recreation-related injuries constitute at least 3 percent of all hospitalizations, however, this number may be somewhat underestimated. It is estimated that 300,000 cases of TBI occur annually in the sports and recreation arena.

According to the National Institutes of Health, TBI results in a wide spectrum of neurological, physiological and psychological disabilities. The neurological consequences of TBI can be extensive and may include movement disorders, seizures, headaches, visual deficits and sleep disorders.  Non-neurological complications may include pulmonary, metabolic, nutritional, gastrointestinal, musculoskeletal and dermatologic problems.

Similarly, TBI can exert significant adverse effects on cognitive functions such as memory, attention, language use, problem solving, abstract reasoning, planning and information processing. Additionally, TBI may trigger significant deficits in social and learning skills, sexual function, emotional control and self-awareness.  TBI is associated with increased rates of suicide, divorce, chronic unemployment, economic strain and substance abuse.  Mild TBI can be masked despite apparent deficits but often can become more significant as the patient ages.

According to the National Institutes of Health, the economic consequences of TBI are enormous.  The annual cost of acute care and rehabilitation in the U.S. for new cases is estimated to be as high as $10 million. A study by the National Foundation for the Brain estimated the annual cost in the U.S for TBI at $48.3 billion.  Hospitalizations account for $31.7 billion and fatal brain injuries cost the nation $16.6 billion.  These figures do not include the economic burden TBI has on families and society.  These cost estimates do not include lost earnings, costs to social service systems and the value of time and foregone earnings of family caregivers.

Stroke: 

Stroke is the third leading cause of death and an important cause of hospital admission and long term disability in most industrialised populations. In the US, over 500,000 people suffer a new or recurrent stroke each year and the incidence in the UK is approximately 100,000 per annum. The total cost of stroke in the US is estimated at approximately $41 billion per year. As a consequence of the ageing population, the incidence of stroke is expected to rise over the next 50 years. 30 per cent. of stroke victims die within one year of stroke with more than half of these deaths occurring within one month of stroke. More importantly, stroke is also the leading cause of long term disability with at least one third of survivors being left with serious disabilities.

Antidepressant

Neuro Biomed is engaged in the development of a series of small peptide-based products to treat central nervous system disorders, with the Company's leading product being an antidepressant.

Depression is a huge market - the World Health Organization estimates that there are 340 million people with depression worldwide. In 1999, the Medical & Healthcare Marketplace Guide estimated that worldwide sales for antidepressant drugs exceeded $11 billion, with an annual growth rate of 24%.

Alzheimer's disease

Multiple Sclerosis

MS is a disease of the CNS that is characterised by chronic inflammation and degradation of the myelin sheath which surrounds nerve cells and contributes to the passing of electrical signals along a nerve fibre. This progressive demyelination occurs at multiple sites in the brain and spinal cord resulting in a gradual deterioration of nerve signalling and of the health of the patient. Approximately 360,000 people in the United States and 360,000 in Europe suffer from MS. BIO-1109 is involved in controlling the cells that form and maintain the myelin sheath insulating nerve axon in the CNS. These cells are thought to be involved early in the demyelination of nerve fibres seen in MS. 

Peripheral neuropathies comprise a collection of disorders that are characterised by the degeneration of sensory and/or motor nerves. This degeneration may be caused by injury, diabetes, chemotherapy, inherited disorders and other factors. It was estimated in 1998 that in excess of two million individuals in the United States suffered from some form of peripheral neuropathy. The largest segments of this population are those with diabetic neuropathies and those with chemotherapy induced neuropathies. There are, at present, no FDA or MCA approved therapeutic agents for the prevention, reduction or reversal of the degeneration and atrophy caused by these disorders and injuries.

Neuropathic Pain

According to the American Chronic Pain Association, 86 million Americans suffer from some form of chronic pain. Diseases and conditions that require novel pain management techniques include cancer, arthritis, stroke, back pain, diabetes and post traumatic nerve injury. Pain represents the most common cause for limitation in the activities of individuals over the age of 45. It is the second most frequent cause for doctor visits and is the third most common reason for surgery in the U.S. Medical economists estimate that pain costs the U.S. economy $100 billion a year in lost productivity.

Current treatments used in pain management are often insufficient or ill suited to the needs of patients who suffer. According to the American Academy of Pain Management, many physicians are not well trained or informed in the discipline of managing pain. Patients who suffer from cancer and other terminal forms of disease often suffer needlessly because pain medication therapy is either inappropriate or under-prescribed. Many patients who are terminally ill or suffer from chronic pain are often reluctant to request higher doses of medication because they fear possible dependence on narcotic pain relief. The euthanasia movement has grown out of the belief that pain cannot be managed effectively for the terminally ill. Narcotics (morphine, dilaudid, methadone and hydrocodone, etc.) are not effective long-term options for chronic, non-terminal illnesses associated with severe pain, because the need for increased doses may lead to dependency. Non-steroidal anti-inflammatory drugs (NSAIDs) used in pain management are only partially effective and may have significant side effects. The overall market size for pain management in the U.S. is conservatively estimated to exceed $7 billion and is growing at 7% per year. This market size demonstrates a significant need for more effective treatment of pain.

Edema

Edema results from stroke, trauma, or brain tumors and causes debilitating or life-threatening consequences. Most forms of severe injury or disease of the brain and spinal cord result in cell swelling or cellular edema. Ionic imbalance underlying edema rapidly leads to cell death by either destroying nerve cells or by physical compression of surrounding brain tissue. The full extent of recovery from injury can be improved by controlling edema, but the outcome is not predictable. Currently, management of cerebral edema following injury is essential to prevent brain herniation (a common cause of death following head injury) and to restoring normal brain function.

Edema is a hallmark of traumatic injury to the brain and spinal cord. It also frequently accompanies stroke and often complicates the clinical course of brain tumors. Current treatments for cerebral edema are very limited and include osmotherapy and glucocorticoids (dexamethasone). The former involves administration of hypertonic mannitol to help reverse the swelling. The beneficial effects of osmotherapy are limited and are often not successful, because osmotherapy shrinks healthy parts of the brain along with the damaged area. Glucocorticoids have not been very successful in the treatment of most forms of edema and in particular have failed in stroke-associated edema. These current treatment forms have been used for the last 30 years with very little success, but represent the current state-of-the-art. The cost of treatment of these disorders exceeds $14 billion annually and is growing.

Brain Cancer

Primary brain cancer or glioma is a particularly rapid and fatal disease and is considered to be one of the most deadly forms of cancer. Gliomas are caused by uncontrolled proliferation of glial cells. According to the American Cancer Society, approximately 20,000 to 24,000 primary brain tumors are reported each year in the U.S. The standards of care are surgery, radiation, chemotherapy, and immunotherapy. Regardless of the treatment, most patients succumb to the disease with half of the afflicted patients dying within the first year. Surgical techniques fail to eradicate the tumor, and other treatments are only palliative There is a 98% recurrence after therapy with a median survival of 3-6 months after recurrence.
 

Debilitating circumstances for victims of these invasive brain tumors begin within weeks and are often fully present only a few months after the onset of the disease. One of the most difficult treatment problems is that glial tumor growth causes compression of surrounding healthy brain tissue resulting in extensive regions of cell death. This in turn causes selective loss of brain function and is often associated with headaches, vomiting, seizures, and personality changes. The developing tumor also outgrows its blood supply resulting in further necrosis and breakdown of the blood-brain barrier with conspicuous hemorrhaging. Since no glioma-specific detection methods are available, unequivocal diagnosis requires surgical removal of tissue for biopsy. Despite the morbidity of this disease, it is relatively rare. The markets for diagnostics and therapies for glioma in the U.S. are estimated at between $250 to $500 million each per year. Glioma is considered an orphan disease because of its rarity, but glioma treatment, on a case-by-case basis, is more expensive than other tumor treatments.