Methods of treating or preventing age related disorders
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Publication Number
US-11266721-B1
Publication Date
2022-03-08
Expiration Date
Abstract
This invention relates to the treatment of age-related disorders with a combination of the hTERT gene and the Follistatin gene in a delivery system such as in an adeno-associated viral vector. The Follistatin gene is expected to promote the division of stem cells that will regenerate the organism and the hTERT will prevent their depletion.
Core Innovation
The invention provides a method of reducing osteoporosis in a mouse by administering a therapeutically effective amount of a human Telomerase Reverse Transcriptase (hTERT) gene in combination with a Follistatin-344 gene. The gene combination is administered as a human hTERT gene together with a Follistatin gene, with Follistatin-344 described as most preferred.
The method further recites improving type II diabetes and/or reducing osteoporosis in a mouse by administering a therapeutically effective amount of a human hTERT gene in combination with a Follistatin-344 gene. The disclosed approaches include administering the gene payload as a nucleic acid selected from a plasmid, phage, bacterial artificial chromosome (BAC), or yeast artificial chromosome (YAC), or delivering the payload in a viral particle.
The disclosed embodiments include using an adeno-associated viral (AAV) vector, a herpesvirus vector, or a baculovirus vector as viral particle delivery options. Administration can be via intravenous, subcutaneous, or intramuscular injections, with a number of injections between 1 and 6, and includes specified dosage ranges for the administered genes.
The document also describes reducing osteoporosis and/or increasing muscle mass in a mouse by administering a therapeutically effective amount of a human hTERT gene in combination with a Follistatin-344 gene. The stated problem addressed is age-related disorders, including osteoporosis and type II diabetes, with the document describing a small clinical study in subjects observing increased muscle mass/physical robustness and dramatic stamina improvement in some subjects.
Claims Coverage
The partial document includes three independent claims covering hTERT gene + Follistatin-344 gene administration in a mouse for reducing osteoporosis, improving type II diabetes and/or reducing osteoporosis, and reducing osteoporosis and/or increasing muscle mass. Across these independents, the inventive core is the combination of a human hTERT gene with a Follistatin-344 gene, with optional refinements by delivery format, viral vector type, injection route, injection count, and dosage ranges.
hTERT and Follistatin-344 combination for reducing osteoporosis
A method of reducing osteoporosis in a mouse by administering to the mouse a therapeutically effective amount of a human Telomerase Reverse Transcriptase (hTERT) gene in combination with a Follistatin-344 gene to reduce osteoporosis.
hTERT and Follistatin-344 combination for improving type II diabetes and/or reducing osteoporosis
A method, comprising administering to a mouse a therapeutically effective amount of a human Telomerase Reverse Transcriptase (hTERT) gene in combination with a Follistatin-344 gene so as to improve type II diabetes and/or reduce osteoporosis.
hTERT and Follistatin-344 combination for reducing osteoporosis and/or increasing muscle mass
A method of reducing osteoporosis and/or increasing muscle mass in a mouse, the method comprising administering to the mouse a therapeutically effective amount of a human Telomerase Reverse Transcriptase (hTERT) gene in combination with a Follistatin-344 gene to reduce osteoporosis and/or increase muscle mass.
All independent claims are directed to administering a therapeutically effective amount of a human hTERT gene together with a Follistatin-344 gene in a mouse, with the therapeutic outcomes targeted to osteoporosis reduction, type II diabetes improvement and/or osteoporosis reduction, and osteoporosis reduction and/or increased muscle mass, respectively. Dependent claim families refine delivery format, viral vector types, and administration constraints including injection route, number of injections, and dosage ranges.
Stated Advantages
Reduces osteoporosis in a mouse.
Improves type II diabetes in a mouse.
Reduces osteoporosis and/or increases muscle mass.
Increases muscle mass/physical robustness in subjects in a small clinical study (as described in the partial content).
Dramatic stamina improvement in some subjects in a small clinical study (as described in the partial content).
Documented Applications
Treatment or prevention of age-related disorders, including sarcopenia/cachexia/anorexia, osteoporosis, and metabolic disorders such as type II diabetes (as described in the partial content).
Reducing osteoporosis in a mouse using hTERT gene in combination with a Follistatin-344 gene (as recited in independent claims and summarized in the partial content).
Improving type II diabetes and/or reducing osteoporosis in a mouse using hTERT gene in combination with a Follistatin-344 gene (as recited in independent claims and summarized in the partial content).
Reducing osteoporosis and/or increasing muscle mass in a mouse using hTERT gene in combination with a Follistatin-344 gene (as recited in independent claims and summarized in the partial content).
Reported observations in a small clinical study of 20 subjects ≤60 years, including increased muscle mass/physical robustness and dramatic stamina improvement in 8 subjects (as described in the partial content).
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