Diabetic Foot Ulcers: Zhittya Regenerative Medicine has
preclinical animal efficacy and toxicity studies to support an
IND (Investigational New Drug) application to the US FDA.
A Phase I Clinical Protocol has been developed and a clinical
trial site has been identified. An IND submission is planned in the
Venous Leg Ulcers: This program is at a similar stage of development as the diabetic foot ulcer
program and Zhittya Regenerative Medicine plans an IND submission to occur after the IND for the diabetic foot ulcers application has been filed.
Coronary Artery Disease: Pre-clinical animal efficacy
and toxicity studies to support an IND application to the
US FDA will be conducted by Zhittya Regenerative Medicine.
Peripheral Artery Disease (PAD): Pre-clinical animal
efficacy and toxicity studies to support an IND application
to the US FDA for this indication will be conducted
by Zhittya Regenerative Medicine.
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Research conducted at the University of Southern California has indicated that flaws in the blood-brain barrier and impaired blood flow in the brain drives the neurodegeneration seen in diseases such as Parkinson’s and others. These USC researchers believe that a substantial proportion of neurogenerative diseases are wholly or partly due to age-related small vessel disease of the brain. In addition, Columbia University researchers discovered that older brains have as many neurons as younger brains but lacked sufficient blood flow.
Parkinson’s Disease: A number of studies conducted in animal models of Parkinson’s Disease indicate that FGF-1 can stimulate the regeneration of dopamine-producing cells in the brain leading to an improvement in the classical Parkinson’s Disease symptoms that these animals display. Based on clinical research with other disorders, it is well established that FGF-1 can also promote the growth and maintenance of a healthy microvasculature in damaged tissues or organs. An FDA approved human trial is planned for 2019.
Stroke: A number of independent efficacy studies in animal models of stroke have been performed that support the potential of FGF-1 to be a benefit for stroke. Zhittya Regenerative Medicine will initiate animal toxicity studies for an IND application.
Vascular Dementia: This condition is also referred to as “multi-infarct dementia” and develops over a period of time after a person suffers numerous mini-strokes. This chronic lack of blood perfusion results in a gradual loss of neurons in the brain and dementia. As FGF-1 can cross the blood-brain barrier, Zhittya Regenerative Medicine will review IV infusions of the drug to see if this treatment can help reverse dementia by bringing additional blood flow to the brain.
Alzheimer’s Disease: Recent work from several medical research groups has indicated that one of the first steps in the development of Alzheimer’s Disease is a degeneration in the microvasculature of the brain. Researchers at McGill University in Canada analyzed more than 7,700 brain images and found that, contrary to previous understanding, the first physiological sign of Alzheimer’s disease is a decrease in blood flow in the brain. This decline in brain perfusion precedes the classical symptoms of this disease including memory loss, plaque deposition outside of nerve cells and “neurofibrillary tangles” within neurons. Zhittya Regenerative Medicine plans to initiate pre-clinical work in animal models of Alzheimer's Disease to see if therapeutic angiogenesis in the brain can delay or reverse the course of this disease.
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The severity of the symptoms is directly related to the degree of blockage of the coronary vessels and can range from mild chest pain on exertion to being classified as a “cardiac cripple” where even getting out of bed is a very difficult function.
WUND Healing BioPharmaceuticals currently has a number of developmental drugs in its portfolio, utilizing different formulations of FGF-1 to treat serious medical indications developed by its research partner, Zhittya Regenerative Medicine.
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