Stroke: A number of independent efficacy studies in animal models of stroke have been completed and support the potential of FGF-1 to be of benefit for stroke. Zhittya will now initiate animal toxicity studies to support an IND application.
Vascular Dementia: This condition is also referred 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, IV infusions of the drug will be examined to see if this treatment can help reverse the dementia by bringing additional blood perfusion to the brain in animal models of vascular dementia.
Alzheimer’s Disease: Very recent work has indicated that one of the first steps in the development of Alzheimer’s Disease is a degeneration in the microvasculature of the brain. This decrease in brain perfusion precedes the classical symptoms of this disease including memory loss, plaque deposition outside of nerve cells and “neurofibrillary tangles” within neurons. Pre-clinical work in animal models of Alzheimer Disease will be initiated to see if therapeutic angiogenesis in the brain can delay or reverse the course of this disease.
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Coronary Artery Disease: Pre-clinical animal efficacy and toxicity studies to support an IND application to the US FDA have been completed. Submission of the IND application is expected within the next 6 months.
Zhittya currently has eight active drug development programs utilizing different formulations of FGF-1 to treat the following medical indications. Zhittya has contracted with a cGMP biologics drug manufacturer to produce clinical and preclinical lots of its drug products to support these programs.
Diabetic foot ulcers: Pre-clinical animal efficacy and toxicity studies to support an IND (Investigational New Drug) application to the US FDA have been completed. A Phase I Clinical Protocol has been developed and a clinical trial site in the Las Vegas area has been identified. An IND submission is planned in the near future.
Venous leg ulcers: This program is at a similar stage of development as the diabetic foot ulcer program and an IND submission is planned to occur after the IND for the diabetic foot ulcers application has been filed.
Peripheral Artery Disease (PAD):
Pre-clinical animal efficacy and toxicity studies to support an IND application to the US FDA for this indication have also been completed and a filing is anticipated in 9-12 months.