Systems And Methods For Predicting Response To Anti-Androgen Therapy For The Treatment Of Androgenetic Alopecia
AssigneeGlobal Life Science Partners Limited
InventorsAndy Ofer Goren, John McCoy
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Abstract
Methods, processes, systems, and apparatuses are disclosed for predicting anti-androgen therapy response in the treatment of androgenetic alopecia based on a fluorometric assay and proteomics.
Claims19
A method for predicting the likely response of a human subject to an anti-androgen therapy, comprising the steps of:
- obtaining a genetic sample from the subject;
- subcloning into a protein expression system at least a portion of an androgen receptor gene within said genetic sample, said portion containing a glutamine repeat sequence in exon 1 of said gene;
- expressing said portion, thereby producing a plurality of copies of a protein;
- purifying said protein;
- determining the number of glutamine repeats in said protein;
- comparing said number to one or more standardized values, each standardized value representing either high or low expected anti-androgen response for a class of patients including the subject, thereby producing an indication of either high or low expected anti-androgen response for the subject;
- and
- presenting the indication to the subject.
A method for predicting the likely response of a human subject to an anti-androgen therapeutic drug for the treatment of androgenic alopecia, comprising the steps of:
- obtaining a first hair follicle sample from the subject, the sample comprising at least one hair follicle;
- combining the first hair follicle sample with the anti-androgen therapeutic drug, a predetermined amount of testosterone, and a fluorogenic dye which competes with dihydrotestosterone (DHT) for reaction with aldo-ketoreductase 1C2 (AKR1C2), wherein the reaction of the fluorogenic dye with AKR1C2 results in a fluorescent product;
- incubating the first sample for a pre-determined time, at a temperature at which AKR1C2 is active;
- measuring a first fluorescence intensity of the first sample at a wavelength emitted by the fluorescent product;
- and
- comparing the first fluorescence intensity with a comparison value.
A method for predicting the likely response of a human subject to an anti-androgen therapeutic drug for the treatment of androgenic alopecia, comprising the steps of:
- obtaining a first hair follicle sample from the subject, the sample comprising at least one hair follicle;
- combining the first hair follicle sample with the anti-androgen therapeutic drug, a predetermined amount of testosterone, and a recombinant yeast strain comprising a plasmid that expresses human recombinant androgen receptor (hAR), said plasmid comprising an androgen response element (ARE) promoting the expression of a reporter gene, such that the reporter gene will be expressed when activated hAR binds to the ARE;
- incubating the first sample for a pre-determined time, at a temperature at which the recombinant yeast strain is active;
- measuring a value representing the degree of expression of the reporter gene;
- and
- comparing said value with a comparison value.
A method for predicting the likely response of a human subject to an anti-androgen therapeutic drug for the treatment of androgenic alopecia, comprising the steps of:
- obtaining a first hair follicle sample from the subject, the sample comprising at least one hair follicle;
- combining the first hair follicle sample with the anti-androgen therapeutic drug and a predetermined amount of testosterone;
- incubating the first sample for a pre-determined time, at a temperature at which cells within the hair follicle are active;
- conducting an ELISA or lateral flow assay to measure a first level of DHT or testosterone within the sample;
- and
- comparing said first level with a comparison value.
Dependencies are inferred from the claim text.