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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Calculate Free Testosterone with TruT by FPT
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<blockquote data-quote="madman" data-source="post: 241135" data-attributes="member: 13851"><p>[URL unfurl="true"]https://xyonetx.com/[/URL]</p><p>[ATTACH=full]27693[/ATTACH]</p><p>[ATTACH=full]27694[/ATTACH]</p><p></p><p>[ATTACH=full]29285[/ATTACH]</p><p></p><p></p><p><strong><u>Endocrine Science</u></strong></p><p></p><p><em><strong>XYone is solving the problems present in the clinical treatment of hormonal disorders such as hypogonadism (Low testosterone condition), Hypothyroidism (Low Thyroxine condition) & other hormonal deficiencies.</strong> These typically. have therapeutic solutions that have poor delivery (pharmacokinetics) and almost no personalized or rational dosing. Through our research, we are creating the first-in-class, programmable release, aqueous, nano/microparticle formulation for testosterone and other hormones where we can program the delivery to create solutions which go from the current one size fit all, empirical treatments to personalized, rational dosing regimens.</em></p><p><em></em></p><p><em><strong>Our first focus is Testosterone & we are proud to announce that our work is being supported by NIH/SBIR grants and we are partnering with the leading institutions in the world to bring our research to the clinic including Brigham & Women’s Hospital, Mayo Clinic, Center for Disease Control, and Karolinka Institute and others.</strong></em></p><p></p><p></p><p></p><p></p><p><strong><u>Accurate measurement of Androgens</u></strong></p><p></p><p><em>Definitive diagnosis and rational management of androgen disorders currently face a number of challenges.</em></p><p><em></em></p><p><em></em></p><p><em></em></p><p><em></em></p><p><em><strong>*Our patent-protected, novel TruT™ companion diagnostic framework provides accurate determination of free testosterone concentrations. This algorithm is based on <u>experimental data demonstrating that testosterone’s binding to SHBG is a multi-step process involving an allosteric interaction between the two binding sites on the SHBG dimer</u>. Estimates of free testosterone derived incorporating the <u>allosteric coupling of SHBG monomers within the dimer</u> provide accurate determination of free testosterone without systematic deviation from values obtained using equilibrium dialysis.</strong></em></p><p><em><strong></strong></em></p><p><em><strong>*Ongoing development is focused around <u>continued study and validation in common conditions characterized by altered binding protein concentrations</u>. Further, the incorporation of estradiol interactions will allow for wider adoption in women where estradiol levels vary greatly across the menstrual cycle. Because hyperandrogenism in women is the second most frequent indication for free testosterone determination, <u>understanding the competitive binding and displacement dynamics</u> is important for proper diagnosis in both healthy menstruating women and women with hyperandrogenic disorders, such as PCOS.</strong></em></p><p></p><p><strong><em>Through collaborations and partnerships, the TruT™ platform presents a unique opportunity to aggregate large volumes of data and metadata across diverse populations, <u>ultimately enabling deeper understanding of the basis of androgen disorders and other conditions</u>.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>[ATTACH=full]27695[/ATTACH]</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong><u>Formulation Development</u></strong></p><p><strong></strong></p><p><strong>Problems with current androgen/hormonal therapies</strong></p><p></p><p><em>Hormonal deficiency supplementation therapies are characterized by absence of improved formulations with optimal PK profiles and patient-friendly dosing. <strong>Our first candidate is Testosterone replacement therapy (TRT).</strong></em></p><p><em></em></p><p><em>Testosterone replacement therapy (TRT) is indicated for the treatment of androgen deficiency in hypogonadal men. The US Food and Drug Administration (FDA) has approved several testosterone formulations for the treatment of hypogonadism in men, including injectable testosterone esters, transdermal testosterone patches, transdermal testosterone gels, and solution, buccal adhesive testosterone tablets, intranasal testosterone, and testosterone pellets & recently oral pills. However, each of these modes of testosterone delivery has significant drawbacks.</em></p><p><em></em></p><p><em>A feature common to the currently available delivery methods is the high variability in bioavailable testosterone as patients vary between super- and sub-therapeutic levels. This results in undesirable side effects and high rates of treatment discontinuation. These side effects include large fluctuations in mood and sexual function. In addition, treatment-specific side effects are noted, such as inadvertent contact transfer associated with testosterone gel formulations; women and children are particularly susceptible to the significant side effects of cross-contamination.</em></p><p><em></em></p><p><em>Thus, there is an unmet clinical need for improved formulations for testosterone replacement therapy (TRT). <strong>The limitations of the currently available testosterone formulations have stimulated tremendous interest in developing long-acting delivery systems that can provide uniform circulating levels of testosterone in the target therapeutic range.</strong></em></p><p></p><p></p><p></p><p></p><p><strong><u>nTc Nano/microparticle Formulation</u></strong></p><p></p><p><em><strong>To address the shortcomings of currently available testosterone formulations, the FPT team is in development of an (nTc) nano/microparticle formulation for sustained, consistent release. This novel next-generation formulation offers the promise of superior pharmacokinetics, uniform delivery of testosterone sustained for four weeks or greater, improved adherence, and treatment outcomes for patients seeking testosterone replacement therapy.</strong></em></p><p></p><p><strong><em>The nTc is a novel proprietary nanoparticle formulation that utilizes FDA-approved biocompatible polymeric materials such as poly (lactic-co-glycolic acid), poly (lactic acid), poly (glycolic acid), poly-l- (glutamic acid), and amphiphilic components. <u>This aqueous formulation eliminates the oil depot-related adverse effects, and as shown in preliminary results, delivers testosterone uniformly without the burst release</u>.</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Personalization of Hormonal Treatments</strong></p><p><strong></strong></p><p><strong><em>We will be able to combine our research in both diagnostics as well as formulations to personalize the treatment of patients uniquely and precisely. Current clinical practice needs multiple office visits as well as lab visits to empirically titrate the correct dosage for a patient. This process needs to be repeated regularly as patient condition changes over time and is a major contributor towards poor adherence and compliance by patients and resulting in suboptimal clinical outcomes. <u>We plan to develop personalized, finely calibrated dosimeters which will enable physicians to accurately determine the dosage for each individual</u>.</em></strong></p></blockquote><p></p>
[QUOTE="madman, post: 241135, member: 13851"] [URL unfurl="true"]https://xyonetx.com/[/URL] [ATTACH type="full" alt="Screenshot (19210).png"]27693[/ATTACH] [ATTACH type="full" alt="1671745684083.png"]27694[/ATTACH] [ATTACH type="full" alt="Screenshot (20762).png"]29285[/ATTACH] [B][U]Endocrine Science[/U][/B] [I][B]XYone is solving the problems present in the clinical treatment of hormonal disorders such as hypogonadism (Low testosterone condition), Hypothyroidism (Low Thyroxine condition) & other hormonal deficiencies.[/B] These typically. have therapeutic solutions that have poor delivery (pharmacokinetics) and almost no personalized or rational dosing. Through our research, we are creating the first-in-class, programmable release, aqueous, nano/microparticle formulation for testosterone and other hormones where we can program the delivery to create solutions which go from the current one size fit all, empirical treatments to personalized, rational dosing regimens. [B]Our first focus is Testosterone & we are proud to announce that our work is being supported by NIH/SBIR grants and we are partnering with the leading institutions in the world to bring our research to the clinic including Brigham & Women’s Hospital, Mayo Clinic, Center for Disease Control, and Karolinka Institute and others.[/B][/I] [B][U]Accurate measurement of Androgens[/U][/B] [I]Definitive diagnosis and rational management of androgen disorders currently face a number of challenges. [B]*Our patent-protected, novel TruT™ companion diagnostic framework provides accurate determination of free testosterone concentrations. This algorithm is based on [U]experimental data demonstrating that testosterone’s binding to SHBG is a multi-step process involving an allosteric interaction between the two binding sites on the SHBG dimer[/U]. Estimates of free testosterone derived incorporating the [U]allosteric coupling of SHBG monomers within the dimer[/U] provide accurate determination of free testosterone without systematic deviation from values obtained using equilibrium dialysis. *Ongoing development is focused around [U]continued study and validation in common conditions characterized by altered binding protein concentrations[/U]. Further, the incorporation of estradiol interactions will allow for wider adoption in women where estradiol levels vary greatly across the menstrual cycle. Because hyperandrogenism in women is the second most frequent indication for free testosterone determination, [U]understanding the competitive binding and displacement dynamics[/U] is important for proper diagnosis in both healthy menstruating women and women with hyperandrogenic disorders, such as PCOS.[/B][/I] [B][I]Through collaborations and partnerships, the TruT™ platform presents a unique opportunity to aggregate large volumes of data and metadata across diverse populations, [U]ultimately enabling deeper understanding of the basis of androgen disorders and other conditions[/U]. [ATTACH type="full" alt="Screenshot (19211).png"]27695[/ATTACH][/I] [U]Formulation Development[/U] Problems with current androgen/hormonal therapies[/B] [I]Hormonal deficiency supplementation therapies are characterized by absence of improved formulations with optimal PK profiles and patient-friendly dosing. [B]Our first candidate is Testosterone replacement therapy (TRT).[/B] Testosterone replacement therapy (TRT) is indicated for the treatment of androgen deficiency in hypogonadal men. The US Food and Drug Administration (FDA) has approved several testosterone formulations for the treatment of hypogonadism in men, including injectable testosterone esters, transdermal testosterone patches, transdermal testosterone gels, and solution, buccal adhesive testosterone tablets, intranasal testosterone, and testosterone pellets & recently oral pills. However, each of these modes of testosterone delivery has significant drawbacks. A feature common to the currently available delivery methods is the high variability in bioavailable testosterone as patients vary between super- and sub-therapeutic levels. This results in undesirable side effects and high rates of treatment discontinuation. These side effects include large fluctuations in mood and sexual function. In addition, treatment-specific side effects are noted, such as inadvertent contact transfer associated with testosterone gel formulations; women and children are particularly susceptible to the significant side effects of cross-contamination. Thus, there is an unmet clinical need for improved formulations for testosterone replacement therapy (TRT). [B]The limitations of the currently available testosterone formulations have stimulated tremendous interest in developing long-acting delivery systems that can provide uniform circulating levels of testosterone in the target therapeutic range.[/B][/I] [B][U]nTc Nano/microparticle Formulation[/U][/B] [I][B]To address the shortcomings of currently available testosterone formulations, the FPT team is in development of an (nTc) nano/microparticle formulation for sustained, consistent release. This novel next-generation formulation offers the promise of superior pharmacokinetics, uniform delivery of testosterone sustained for four weeks or greater, improved adherence, and treatment outcomes for patients seeking testosterone replacement therapy.[/B][/I] [B][I]The nTc is a novel proprietary nanoparticle formulation that utilizes FDA-approved biocompatible polymeric materials such as poly (lactic-co-glycolic acid), poly (lactic acid), poly (glycolic acid), poly-l- (glutamic acid), and amphiphilic components. [U]This aqueous formulation eliminates the oil depot-related adverse effects, and as shown in preliminary results, delivers testosterone uniformly without the burst release[/U].[/I] Personalization of Hormonal Treatments [I]We will be able to combine our research in both diagnostics as well as formulations to personalize the treatment of patients uniquely and precisely. Current clinical practice needs multiple office visits as well as lab visits to empirically titrate the correct dosage for a patient. This process needs to be repeated regularly as patient condition changes over time and is a major contributor towards poor adherence and compliance by patients and resulting in suboptimal clinical outcomes. [U]We plan to develop personalized, finely calibrated dosimeters which will enable physicians to accurately determine the dosage for each individual[/U].[/I][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Calculate Free Testosterone with TruT by FPT
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