Phase 2, Open-Label Extension Study to Assess Long-Term Safety and Tolerability of Enobosarm (GTx 024) in Postmenopausal Women With Stress Urinary Incontinence

This open-label extension study, for subjects from the G201002 study, will provide additional long-term safety and tolerability data for GTx-024. All subjects in this study will receive GTx-024 3 mg orally, once daily.

开始日期2018-06-28

申办/合作机构

GTx, Inc.

NCT03508648 / Withdrawn临床2期

Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.

开始日期2018-05-28

申办/合作机构

GTx, Inc.

NCT03241342 / Completed临床2期

Double-Blind, Placebo-Controlled, Parallel Design, Phase 2 Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in postmenopausal women. Urinary incontinence and pelvic floor disorders are major health problems for women, especially as they age. Pelvic floor muscle relaxation has been found to correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and lower urinary tract are crucial for supporting the pelvic organs and micturition; however, damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and known potential risks have limited their use. Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower urinary tract disorders, as both testosterone and its more potent metabolite, dihydrotestosterone, have anabolic effects on muscle.

开始日期2017-08-21

申办/合作机构

GTx, Inc.

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项与 GTx, Inc. 相关的文献（医药）

2023-09-01·Journal of nuclear medicine technology

Report on the PET/CT Image-Based Radiation Dosimetry of [¹⁸F]FDHT in Women, a Validated Imaging Agent with New Applications for Evaluation of Androgen Receptor Status in Women with Metastatic Breast Cancer.

Article

作者: Abbott, Amanda ; Liu, Mofei ; Cheng, Su-Chun ; Young, Diane ; Overmoyer, Beth ; Jacene, Heather ; McCall, Keisha C ; Van den Abbeele, Annick D ; Johnston, Mayzie ; Dubey, Shipra

In a prospective clinical trial, [¹⁸F]fluoro-5α-dihydrotestosterone ([¹⁸F]FDHT), the radiolabeled analog of the androgen dihydrotestosterone, was used as a PET/CT imaging agent for in vivo assessment of metastatic androgen receptor-positive breast cancer in postmenopausal women. To our knowledge, this article presents the first report of PET/CT image-based radiation dosimetry of [¹⁸F]FDHT in women. Methods: [¹⁸F]FDHT PET/CT imaging was performed on a cohort of 11 women at baseline before the start of therapy and at 2 additional time points during selective androgen receptor modulator (SARM) therapy for androgen receptor-positive breast cancer. Volumes of interest (VOIs) were placed over the whole body and within source organs seen on the PET/CT images, and the time-integrated activity coefficients of [¹⁸F]FDHT were derived. The time-integrated activity coefficients for the urinary bladder were calculated using the dynamic urinary bladder model in OLINDA/EXM software, with biologic half-life for urinary excretion derived from VOI measurements of the whole body in postvoid PET/CT images. The time-integrated activity coefficients for all other organs were calculated from VOI measurements in the organs and the physical half-life of ¹⁸F. Organ dose and effective dose calculations were then performed using MIRDcalc, version 1.1. Results: At baseline before SARM therapy, the effective dose for [¹⁸F]FDHT in women was calculated as 0.020 ± 0.0005 mSv/MBq, and the urinary bladder was the organ at risk, with an average absorbed dose of 0.074 ± 0.011 mGy/MBq. Statistically significant decreases in liver SUV or uptake of [¹⁸F]FDHT were found at the 2 additional time points on SARM therapy (linear mixed model, P < 0.05). Likewise, absorbed dose to the liver also decreased by a small but statistically significant amount at the 2 additional time points (linear mixed model, P < 0.05). Neighboring abdominal organs of the gallbladder wall, stomach, pancreas, and adrenals also showed statistically significant decreases in absorbed dose (linear mixed model, P < 0.05). The urinary bladder wall remained the organ at risk at all time points. Absorbed dose to the urinary bladder wall did not show statistically significant changes from baseline at any of the time points (linear mixed model, P ≥ 0.05). Effective dose also did not show statistically significant changes from baseline (linear mixed model, P ≥ 0.05). Conclusion: Effective dose for [¹⁸F]FDHT in women before SARM therapy was calculated as 0.020 ± 0.0005 mSv/MBq. The urinary bladder wall was the organ at risk, with an absorbed dose of 0.074 ± 0.011 mGy/MBq.

2022-01-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Imaging Androgen Receptors in Breast Cancer with ¹⁸F-Fluoro-5α-Dihydrotestosterone PET: A Pilot Study

Article

作者: Abbott, Amanda ; Liu, Mofei ; Overmoyer, Beth ; Cheng, Su-Chun ; Johnston, Mayzie ; Jacene, Heather ; McCall, Keisha ; Van den Abbeele, Annick D ; Young, Diane ; Dubey, Shipra

Most breast cancers express androgen receptors (ARs). This prospective imaging substudy explored imaging of ARs with ¹⁸F-fluoro-5α-dihydrotestosterone (¹⁸F-FDHT) PET in patients with metastatic breast cancer (MBC) receiving selective AR modulation (SARM) therapy (GTx-024). Methods: Eleven postmenopausal women with estrogen receptor-positive MBC underwent ¹⁸F-FDHT PET/CT at baseline and at 6 and 12 wk after starting SARM therapy. Abnormal tumor ¹⁸F-FDHT uptake was quantified using SUV_max AR status was determined from tumor biopsy specimens. ¹⁸F-FDHT SUV_max percentage change between scans was calculated. Best overall response was categorized as clinical benefit (nonprogressive disease) or progressive disease using RECIST 1.1. Results: The median baseline ¹⁸F-FDHT SUV_max was 4.1 (range, 1.4-5.9) for AR-positive tumors versus 2.3 (range, 1.5-3.2) for AR-negative tumors (P = 0.22). Quantitative AR expression and baseline ¹⁸F-FDHT uptake were weakly correlated (Pearson ρ = 0.39, P = 0.30). Seven participants with clinical benefit at 12 wk tended to have larger declines in ¹⁸F-FDHT uptake than did those with progressive disease both at 6 wk after starting GTx-024 (median, -26.8% [range, -42.9% to -14.1%], vs. -3.7% [range,-31% to +29%], respectively; P = 0.11) and at 12 wk after starting GTx-024 (median, -35.7% [range, -69.5% to -7.7%], vs. -20.1% [range, -26.6% to +56.5%], respectively; P = 0.17). Conclusion: These hypothesis-generating data suggest that ¹⁸F-FDHT PET/CT is worth further study as an imaging biomarker for evaluating the response of MBC to SARM therapy and reiterate the feasibility of including molecular imaging in multidisciplinary therapeutic trials.

2020-12-01·Clinical genitourinary cancer3区 · 医学

Phase 2 Trial of GTx-758, an Estrogen Receptor Alpha Agonist, in Men With Castration-Resistant Prostate Cancer

3区 · 医学

Article

作者: Getzenberg, Robert H ; Taylor, Ryan ; Hancock, Michael L ; Flaig, Thomas ; Yu, Evan Y ; Hardigan, Patrick C ; Aronson, William ; Tutrone, Ronald ; Belkoff, Laurence

INTRODUCTION:

Novel estrogen therapy has the potential to be efficacious, with a favorable adverse event profile, in castration-resistant prostate cancer (CRPC). We performed a phase 2 trial to assess the ability of GTx-758, an oral selective estrogen receptor alpha agonist, to result in a ≥ 50% PSA decline by day 90, modulate free testosterone and sex hormone-binding globulin (SHBG) levels, and affect estrogen deficiency adverse events.

PATIENTS AND METHODS:

CRPC patients received GTx-758 in two dose cohorts, 125 and 250 mg/d. The primary endpoint was the proportion of subjects who experienced a ≥ 50% PSA decline by day 90. Secondary endpoints included changes in testosterone, SHBG, bone turnover markers, and hot flashes, as well as safety.

RESULTS:

Four (10.5%) of 38 (95% CI, 2.9, 24.8; P = .120) and 10 (25.6%) of 39 patients (95% CI, 13.0, 42.1; P < .001) in the GTx-758 125 and 250 mg/d cohorts, respectively, experienced ≥ 50% PSA decline. SHBG was increased, providing a mechanism for notable decreases in free testosterone. In the 250 mg/d cohort, 9 men presented with moderate to severe hot flashes, and after 12 weeks, 4 (44%) of 9 reported either mild or no hot flashes (P = .001). The rate of venous thromboembolic events was 0% and 5.1% in the 125 and 250 mg/d arms, respectively.

CONCLUSION:

GTx-758 has clinical activity for CRPC in a dose-dependent fashion. GTx-758 resulted in a reduction in hot flashes. On the basis of these findings, further clinical investigation of novel estrogen therapies is warranted.

项与 GTx, Inc. 相关的新闻（医药）

2023-08-03

·GlobeNewswire-Health Care

MaxCyte Signs Strategic Platform License with Prime Medicine to Advance Next-Generation Gene Editing Therapies for Patients

Prime Medicine to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to advance their innovative Prime Editing technology and develop a new class of one-time, potentially curative therapies MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic partnership with Prime Medicine, Inc., a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies. Under the terms of the agreement, Prime Medicine obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive annual license fees and program-related revenue. “We are pleased to partner with Prime Medicine and support their breakthrough gene editing technology,” said Doug Doerfler, President and CEO of MaxCyte. “The company’s innovative vision and transformative scientific approach are clearly reshaping how genetic diseases are studied and ultimately will be treated.” Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. MaxCyte’s ExPERT™ instrument portfolio is the next generation of leading, clinically-validated electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability, and enhanced functionality, the ExPERT™ platform delivers the high-end performance essential to enabling the next wave of biological and cellular therapeutics. Prime Medicine is MaxCyte’s 23rd strategic partnership overall, each of which generates pre-commercial milestone revenue and the vast majority of which include sales-based payments. About MaxCyte At MaxCyte, we pursue cell engineering excellence to maximize the potential of cells to improve patients’ lives. We have spent more than 20 years honing our expertise by building best-in-class platforms, perfecting the art of the transfection workflow, and venturing beyond today’s processes to innovate tomorrow’s solutions. Our ExPERT™ platform, which is based on our Flow Electroporation technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT™ family of products includes: four instruments, the ATx™, STx™, GTx™ and VLx ™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio. By providing our partners with the right technology, as well as technical and regulatory support, we aim to guide them on their journey to transform human health. Learn more at maxcyte.com and follow us on Twitter and LinkedIn. The content above comes from the network. if any infringement, please contact us to modify.

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2022-11-02

·BioSpace

MaxCyte to Participate in Upcoming November 2022 Investor Conferences

ROCKVILLE, Md., Nov. 02, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced Company management will participate in the following investor conferences: Stifel Healthcare Conference Wednesday, November 16th at 3:00 p.m. Eastern Time Stephens Annual Investment Conference Thursday, November 17th at 10:00 a.m. Eastern Time Live and archived webcasts of the events will be available on the “Events” section of the MaxCyte investor relations website at . About MaxCyte MaxCyte is a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and to support innovative, cell-based research. Over the past 20 years, we have developed and commercialized our proprietary Flow Electroporation® technology, which facilitates complex engineering of a wide variety of cells. Our ExPERT™ platform, which is based on our Flow Electroporation technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: four instruments, the ATx™, STx™ GTx™ and VLx™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio. MaxCyte Contacts: US IR Adviser Gilmartin Group David Deuchler, CFA +1 415-937-5400 jr@maxcyte.com US Media Relations Seismic Collaborative, A Spectrum Science Company Valerie Enes +1 408-497-8568 valerie@teamseismic.com Nominated Adviser and Joint Corporate Broker Panmure Gordon Emma Earl / Freddy Crossley Corporate Broking Rupert Dearden +44 (0)20 7886 2500 UK IR Adviser Consilium Strategic Communications Mary-Jane Elliott / Chris Welsh +44 (0)203 709 5700 maxcyte@consilium-comms.com

细胞疗法

2022-10-12

·BioSpace

MaxCyte to Report Third Quarter 2022 Financial Results on November 9, 2022

ROCKVILLE, Md., Oct. 12, 2022 (GLOBE NEWSWIRE) --MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announced that it will release financial results for the third quarter of 2022 after the U.S. market close on Wednesday, November 9th, 2022. Company management will host a conference call to discuss financial results at 4:30 p.m. Eastern Time. Conference Call Details Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the “Events” section of the MaxCyte website at . About MaxCyte MaxCyte is a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization. Over the past 20 years, we have developed and commercialized our proprietary Flow Electroporation® platform, which facilitates complex engineering of a wide variety of cells. Our ExPERT™ platform, which is based on our Flow Electroporation technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: four instruments, the ATx™, STx™ GTx™ and VLx™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio. MaxCyte Contacts: US IR Adviser Gilmartin Group David Deuchler, CFA +1 415-937-5400 ir@maxcyte.com Nominated Adviser and Joint Corporate Broker Panmure Gordon Emma Earl / Freddy Crossley Corporate Broking Rupert Dearden +44 (0)20 7886 2500 UK IR Adviser Consilium Strategic Communications Mary-Jane Elliott / Chris Welsh +44 (0)203 709 5700 maxcyte@consilium-comms.com

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药物(靶点)	适应症	全球最高研发状态

枸橼酸托瑞米芬 ( ER )	前列腺癌更多	终止
Enobosarm ( AR )	恶病质更多	终止
Andarine ( AR )	骨质疏松症更多	终止
MK-3984 ( AR )	肌肉减少症更多	终止
GTx-878 ( ERβ )	黄斑变性更多	无进展