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Patent Issued for Systems and Methods for Predicting Response to Anti-Androgen Therapy for the Treatment of Androgenetic Alopecia

July 7, 2014



By a News Reporter-Staff News Editor at Clinical Trials Week -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Goren, Andy Ofer (Newport Beach, CA); McCoy, John (Downey, CA), filed on October 15, 2012, was published online on June 24, 2014 (see also Global Life Science Partners Limited).

The patent's assignee for patent number 8758993 is Global Life Science Partners Limited (Central, HK).

News editors obtained the following quote from the background information supplied by the inventors: "Hair loss is associated with a variety of psychological and social implications. Prior to starting any treatment it is advantageous to predict the course, severity, and treatment options of the disease. In the field of hair loss, very little scientific diagnostic tests are currently available, and there are few methods to predict treatment response.

"Moreover, the hair loss industry is littered with dozens of products that claim to grow, improve, and replace hair. Unfortunately, few treatments have been scientifically demonstrated to work, and the few treatments that have undergone clinical trials often do not work equally for all patients.

"Androgenetic alopecia has been successfully treated in men by the U.S. Food & Drug Administration ('FDA') approved medication Finasteride (marketed as Propecia) as well as by off-label anti-androgen drugs. The drugs ultimately influence gene transcription mediated by the Androgen Receptor complex.

"Among various individuals, whether male or female, there is a broad variability in the response of different people to various hair loss treatments. This variability is a result of a complex interaction of genetic and physiological factors contributing to variable androgen receptor control of gene transcription, making a one-size-fits-all approach difficult to achieve. It would therefore be advantageous to be able to have an effective diagnostic method where patients could be selected and treated on the basis of direct physiological activity assay, which would identify some people as being likely to benefit from treatment by anti-androgen therapies, while identifying other individuals in which treatment is not likely to be effective."

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors' summary information for this patent: "The inventions described here relate to systems and methods for predicting anti-androgen therapy response, such as in the treatment of androgenetic alopecia. Various embodiments are possible, a number of which are exemplified here.

"In one embodiment of the present disclosure, a method is provided 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.

"In another embodiment described herein a method is provide 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.

"In yet another embodiment disclosed herein, a method is provided 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.

"In another embodiment disclosed herein, a method is provided 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.

"Various embodiments and variations of the inventions described herein are also provided, and various modification and variations will be suggested to one of skill in the art having the benefit of this disclosure."

For additional information on this patent, see: Goren, Andy Ofer; McCoy, John. Systems and Methods for Predicting Response to Anti-Androgen Therapy for the Treatment of Androgenetic Alopecia. U.S. Patent Number 8758993, filed October 15, 2012, and published online on June 24, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8758993.PN.&OS=PN/8758993RS=PN/8758993

Keywords for this news article include: Alopecia, Genetics, Hair Loss, Dermatology, Legal Issues, Therapeutics, Hair Diseases, Hypotrichosis, Skin Diseases, Skin and Connective Tissue Diseases, Global Life Science Partners Limited.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Clinical Trials Week


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