madman
Super Moderator
Where it stands as of now.
Summed up here!
Dr. Bhasin and Dr. Jasuja Xyone therapeutics 2025!
ABSTRACT
Background
Measurement of free testosterone (T) concentrations is indicated in the diagnosis of androgen disorders, including hypogonadism in men; hirsutism, polycystic ovary syndrome (PCOS), and androgenic alopecia in women; pubertal disorders in boys and management of gender affirming hormone therapies for transgender and gender diverse (TGD) persons. This Phase IIB proposal aims to continue the development of the TruTTM algorithm by validating it in common conditions characterized by altered estradiol (E2), T, and SHBG concentrations and incorporating interaction of E2 with T for wider commercial adoption in women in whom E2 levels vary greatly across the menstrual cycle and in TGD population.
Approach
This application follows the FDA’s published “Guidance for Industry: Bioanalytical Method Validation”. The essential parameters to determine the acceptability of a bioanalytical method include its technical performance (accuracy, precision, sensitivity, selectivity, stability, and matrix effects). Reference ranges should be determined in appropriate human samples. The analytical method should be validated for intended use (e.g., determination in conditions of intended use, such as persons with altered E2 and T levels, women with PCOS, TGD persons etc.). In studies through the Phase II, we demonstrated that the method has superior performance characteristics and extended the validation of TruTTM algorithm in conditions characterized by altered SHBG concentrations. In the proposed Phase IIB studies, we will generate the v2.0 of TruTTM algorithm by incorporating the dynamics of the E2 induced perturbation in free T levels, validate it in men, women and TGD populations (Aim 1) and deploy HIPAA compliant, secure integration of the algorithm into electronic medical records (EMR) workflow (Aim 2).
Future Directions and Commercialization potential
The phase IIB program will enable the pilot commercial deployment of a HIPAA compliant (FDA registered) platform for commercializing the TruTTM (v2.0) algorithm embedded into electronic medical record (EMR) for wider clinical adoption. These studies will improve clinical care and advance our fundamental understanding of dynamic regulation of T bioavailability in diverse populations including unrepresented sexual and gender minorities.
Project Start Date
15-September-2014
Project End Date
21-March-2025
Budget Start Date
01-September-2023
Budget End Date
21-March-2025
Project Start Date
15-September-2014
Project End Date
31-August-2024
Budget Start Date
30-September-2022
Budget End Date
31-August-2023
Project Start Date
15-September-2014
Project End Date
31-May-2022
Budget Start Date
01-July-2018
Budget End Date
31-May-2022
Project Start Date
15-September-2014
Project End Date
31-May-2019
Budget Start Date
15-September-2017
Budget End Date
31-May-2018
Project Start Date
15-September-2014
Project End Date
31-August-2016
Budget Start Date
15-September-2014
Budget End Date
31-August-2016
FPT strives to innovate at a high level, maintain our access to academic research and pre-eminence in this content area, and to optimally balance research and commercial success. We are based in the suburbs of Boston and within reach of some of the most renowned endocrine research and clinical centers in the world. Our research partners are spread throughout USA and we have research collaborations with leading institutions in Europe. These networks provide us the opportunity to share and validate our findings and enable us to leverage from a global palette of resources.
We continue to work with collaborators in academia and the wider industry for exciting new applications and further development of TruT™. Some of our existing partnerships include:
Johns Hopkins University ‐ Diagnosis and management of hypogonadism in HIV and co-infections.
The Mayo Clinic ‐ Personalized algorithm and therapy development.
Karolinska Institute ‐ Dynamics of free testosterone levels after surgical interventions in men and women.
regionh.dk - Examining population reference ranges of free testosterone for Danish cohorts.
UCLA School of Nursing ‐ Examining the dynamic role of multiple hormones in altering transport and bioavailability.
Boston IVF ‐ Developing a novel platform for rational treatment and management of in-vitro fertilization interventions.
Myosyntax ‐ Dynamics of testosterone bioavailability during caloric restriction.
© 2021 Function Promoting Therapies, LLC
© 2025. All Rights Reserved
Summed up here!
Dr. Bhasin and Dr. Jasuja Xyone therapeutics 2025!
ABSTRACT
Background
Measurement of free testosterone (T) concentrations is indicated in the diagnosis of androgen disorders, including hypogonadism in men; hirsutism, polycystic ovary syndrome (PCOS), and androgenic alopecia in women; pubertal disorders in boys and management of gender affirming hormone therapies for transgender and gender diverse (TGD) persons. This Phase IIB proposal aims to continue the development of the TruTTM algorithm by validating it in common conditions characterized by altered estradiol (E2), T, and SHBG concentrations and incorporating interaction of E2 with T for wider commercial adoption in women in whom E2 levels vary greatly across the menstrual cycle and in TGD population.
Approach
This application follows the FDA’s published “Guidance for Industry: Bioanalytical Method Validation”. The essential parameters to determine the acceptability of a bioanalytical method include its technical performance (accuracy, precision, sensitivity, selectivity, stability, and matrix effects). Reference ranges should be determined in appropriate human samples. The analytical method should be validated for intended use (e.g., determination in conditions of intended use, such as persons with altered E2 and T levels, women with PCOS, TGD persons etc.). In studies through the Phase II, we demonstrated that the method has superior performance characteristics and extended the validation of TruTTM algorithm in conditions characterized by altered SHBG concentrations. In the proposed Phase IIB studies, we will generate the v2.0 of TruTTM algorithm by incorporating the dynamics of the E2 induced perturbation in free T levels, validate it in men, women and TGD populations (Aim 1) and deploy HIPAA compliant, secure integration of the algorithm into electronic medical records (EMR) workflow (Aim 2).
Future Directions and Commercialization potential
The phase IIB program will enable the pilot commercial deployment of a HIPAA compliant (FDA registered) platform for commercializing the TruTTM (v2.0) algorithm embedded into electronic medical record (EMR) for wider clinical adoption. These studies will improve clinical care and advance our fundamental understanding of dynamic regulation of T bioavailability in diverse populations including unrepresented sexual and gender minorities.
Project Start Date
15-September-2014
Project End Date
21-March-2025
Budget Start Date
01-September-2023
Budget End Date
21-March-2025
Project Start Date
15-September-2014
Project End Date
31-August-2024
Budget Start Date
30-September-2022
Budget End Date
31-August-2023
Project Start Date
15-September-2014
Project End Date
31-May-2022
Budget Start Date
01-July-2018
Budget End Date
31-May-2022
Project Start Date
15-September-2014
Project End Date
31-May-2019
Budget Start Date
15-September-2017
Budget End Date
31-May-2018
Project Start Date
15-September-2014
Project End Date
31-August-2016
Budget Start Date
15-September-2014
Budget End Date
31-August-2016
Function Promoting Therapies
Function Promoting Therapies, LLC, and Tesvgen, the commercialization arm of FPT, LLC, were established in 2012. The company’s goals are to provide advanced technologies that improve accuracy in the diagnosis and rational management of testosterone replacement therapy for male reproductive disorders.FPT strives to innovate at a high level, maintain our access to academic research and pre-eminence in this content area, and to optimally balance research and commercial success. We are based in the suburbs of Boston and within reach of some of the most renowned endocrine research and clinical centers in the world. Our research partners are spread throughout USA and we have research collaborations with leading institutions in Europe. These networks provide us the opportunity to share and validate our findings and enable us to leverage from a global palette of resources.
Partners and Collaborations
We continue to work with collaborators in academia and the wider industry for exciting new applications and further development of TruT™. Some of our existing partnerships include:
Johns Hopkins University ‐ Diagnosis and management of hypogonadism in HIV and co-infections.
The Mayo Clinic ‐ Personalized algorithm and therapy development.
Karolinska Institute ‐ Dynamics of free testosterone levels after surgical interventions in men and women.
regionh.dk - Examining population reference ranges of free testosterone for Danish cohorts.
UCLA School of Nursing ‐ Examining the dynamic role of multiple hormones in altering transport and bioavailability.
Boston IVF ‐ Developing a novel platform for rational treatment and management of in-vitro fertilization interventions.
Myosyntax ‐ Dynamics of testosterone bioavailability during caloric restriction.
Investors
Tesvgen is funded through the seed investment round in Function Promoting Therapies LLC. FPT successfully closed the seed round in 2016 and is currently in discussions with strategic partners for further commercialization of innovations.
© 2021 Function Promoting Therapies, LLC
© 2025. All Rights Reserved
