Delving into the Latest Updates on Gallium-68-THP PSMA with Synapse

Overview

Basic Info

Drug Type

Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals

Synonyms

68Ga-THP-PSMA

Target

PSMA

Mechanism

PSMA inhibitors(Prostate-specific membrane antigen inhibitors), PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication-

Inactive Indication

Prostatic Cancer

Originator Organization

Theragnostics Ltd.Startup

Active Organization-

Inactive Organization

Theragnostics Ltd.Startup

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.

Start Date18 Jun 2018

Sponsor / Collaborator

Theragnostics Ltd.Startup

EUCTR2017-005010-59-GB

/ Not yet recruitingPhase 2

A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients with High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatment

Start Date17 May 2018

Sponsor / Collaborator

Theragnostics Ltd.Startup

100 Clinical Results associated with Gallium-68-THP PSMA

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100 Translational Medicine associated with Gallium-68-THP PSMA

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100 Patents (Medical) associated with Gallium-68-THP PSMA

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7

Literatures (Medical) associated with Gallium-68-THP PSMA

01 Oct 2023·Cancer science

Promotion of squamous cell carcinoma tumorigenesis by oncogene-mediated THG-1/TSC22D4 phosphorylation.

Article

Author: Kato, Yukinari ; Okita, Yukari ; Watanabe, Yukihide ; Suzuki, Hiroyuki ; Kato, Mitsuyasu ; Okano, Yasuhito ; Goto, Nohara ; Zheng, Ling

Carcinoma cells possess high proliferative and invasive potentials and exhibit a resilience against stresses, metabolic disorder, and therapeutic efforts. These properties are mainly acquired by genetic alterations including driver gene mutations. However, the detailed molecular mechanisms have not been fully elucidated. Here, we provide a novel mechanism connecting oncogenic signaling and the tumorigenic properties by a transforming growth factor-β1-stimulated clone 22 (TSC-22) family protein, THG-1 (also called as TSC22D4). THG-1 is localized at the basal layer of normal squamous epithelium and overexpressed in squamous cell carcinomas (SCCs). THG-1 knockdown suppressed SCC cell proliferation, invasiveness, and xenograft tumor formation. In contrast, THG-1 overexpression promoted the EGF-induced proliferation and stratified epithelium formation. Furthermore, THG-1 is phosphorylated by the receptor tyrosine kinase (RTK)-RAS-ERK pathway, which promoted the oncogene-mediated tumorigenesis. Moreover, THG-1 involves in the alternative splicing of CD44 variants, a regulator of invasiveness, stemness, and oxidative stress resistance under the RTK pathway. These findings highlight the pivotal roles of THG-1 as a novel effector of SCC tumorigenesis, and the detection of THG-1 phosphorylation by our established specific antibody could contribute to cancer diagnosis and therapy.

01 Dec 2021·Journal of Nuclear MedicineQ1 · MEDICINE

A Phase II, Open-Label Study to Assess Safety and Management Change Using ⁶⁸Ga-THP PSMA PET/CT in Patients with High-Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment: The PRONOUNCED Study

Q1 · MEDICINE

Article

Author: Payne, Heather ; Priftakis, Dimitrios ; Cook, Gary J R ; Needleman, Sarah ; Ferris, Michael ; Meagher, Marie ; Davda, Reena ; Hines, John ; Afaq, Asim ; Mitra, Anita ; Orczyk, Clement ; Mullen, Greg ; Warbey, Victoria S ; Kelkar, Anand ; Bomanji, Jamshed

Objectives: To assess the safety and clinical impact of a novel, kit-based formulation of ⁶⁸Ga-THP PSMA positron emission tomography/computed tomography (PET/CT) when used to guide the management of patients with prostate cancer (PCa). Methods: Patients were prospectively recruited in to one of: Group A: high-risk untreated prostate cancer; Gleason score >4+3, or PSA >20 ng/mL or clinical stage >T2c. Group B: biochemical recurrence (BCR) and eligible for salvage treatment after radical prostatectomy with two consecutive rises in prostate specific antigen (PSA) with a three month interval in between reads and final PSA >0.1 ng/mL or a PSA level >0.5 ng/mL. Group C: BCR with radical curative radiotherapy or brachytherapy at least three months prior to enrolment, and an increase in PSA level >2.0 ng/mL above the nadir level after radiotherapy or brachytherapy. Patients underwent evaluation with PET/CT 60 minutes following intravenous administration of 160±30 MBq of ⁶⁸Ga-THP PSMA. Safety was assessed by means including vital signs, cardiovascular profile, serum haematology, biochemistry, urinalysis, PSA, and Adverse Events (AEs). A change in management was reported when the predefined clinical management of the patient altered as a result of ⁶⁸Ga-THP PSMA PET/CT findings. Results: Forty-nine patients were evaluated with PET/CT; 20 in Group A, 21 in Group B and 8 in Group C. No patients experienced serious AEs discontinued the study due to AEs, or died during the study. Two patients had Treatment Emergent AEs attributed to ⁶⁸Ga-THP-PSMA (pruritus in one patient and intravenous catheter site rash in another). Management change secondary to PET/CT occurred in 42.9% of all patients; 30% in Group A, 42.9% in Group B and 75% in Group C. Conclusion: ⁶⁸Ga-THP PSMA was safe to use with no serious AE and no AE resulting in withdrawal from the study. ⁶⁸Ga-THP PSMA PET/CT changed the management of patients in 42.9% of the study population, comparable to studies using other PSMA tracers. These data form the basis of a planned Phase III study of ⁶⁸Ga-THP PSMA in patients with prostate cancer.

01 Dec 2019·Journal of Nuclear Medicine Technology

Current Status of Radionuclide Renal Cortical Imaging in Pyelonephritis

Review

Author: Sarikaya, Ismet ; Sarikaya, Ali

Pyelonephritis is an infection of the kidneys that is seen more commonly in children than the adults. ^99mTc-dimercaptosuccinic acid (^99mTc-DMSA) scanning is a radionuclide imaging study to detect renal scarring after acute pyelonephritis (a late ^99mTc-DMSA scan) and also helps to diagnose acute pyelonephritis in febrile urinary tract infections (an acute ^99mTc-DMSA scan). Planar imaging in multiple views (posterior and bilateral posterior oblique) is generally used. Pinhole imaging with a high-resolution-collimator magnification of each kidney allows detection of smaller cortical defects. SPECT is optional. SPECT/CT is not recommended in children because it has a higher radiation exposure than routine ^99mTc-DMSA scans. The main limitations of ^99mTc-DMSA scanning include a relatively long waiting time after radiotracer injection, a long acquisition time, and a high radiation dose, which is particularly important in repeated studies on children and with the limited spatial resolution of γ-cameras. ^99mTc-glucoheptonate is an alternative radiotracer when ^99mTc-DMSA is not available. Radiotracers for dynamic renal functional imaging can grossly assess the renal cortex in the first few minutes of imaging. ⁶⁸Ga-prostate-specific membrane antigen ligand (⁶⁸Ga-PSMA ligand) PET has the ability to provide images of normal renal cortex and demonstrate renal cortical defects from cysts. In this article, we assess the current status of renal cortical imaging and present ⁶⁸Ga-PSMA ligand PET images. ⁶⁸Ga-PSMA ligand provides excellent renal cortical images, and studies should be done to compare ⁶⁸Ga-PSMA ligand PET with ^99mTc-DMSA scanning in renal diseases, particularly in pyelonephritis.

100 Deals associated with Gallium-68-THP PSMA

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 2	GB	Theragnostics Ltd.Startup	18 Jun 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IAEA-PSMA (ASCO2021)	Phase 3	Recurrent Prostate Carcinoma	1,198	Gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging (68Ga-PSMA PET/CT)	lswsezrmwr(ngsmdapmju) = omybwmjxti rmezqprhvr (unrkcecgzf )	-	28 May 2021
EANM2018	Not Applicable	-	102	Ga-68-HBED-PSMA-11	ngwvpftctc(zkpbnykklz) = egveusfhne msyiwhihwi (zepajvlclu ) View more	Negative	18 Sep 2018
				Ga-68-THP-PSMA	ngwvpftctc(zkpbnykklz) = frecxbmaix msyiwhihwi (zepajvlclu ) View more
EANM2017	Not Applicable	PSMA-Positive Tumor PSMA expression	25	68 Ga-THP-PSMA	arsvnablog(pflvsjlsis) = tywtomdjdn rfmwwjmflx (wxcfeodykw, 0.8 - 1.7) View more	-	11 Sep 2017
ACTRN12615001324505 (Cold Kit PSMA Imaging, SNMMI2017)	Early Phase 1	Prostatic Cancer Gleason score \| PSA	14	68Ga-THP-PSMA68 Ga-THP-PSMA (68Ga-THP-PSMA)	wzrmiekaor(ceuetcdmjx) = No adverse events occurred vublrfoccd (aesxnsnirt )	Positive	24 May 2017
				68Ga-HBED-PSMA
ASCO2015	Not Applicable	Non-metastatic prostate cancer	332	<sup>68</sup>Gallium-labelled ligand of prostate-specific membrane antigen (<sup>68</sup>Ga-HBED-PSMA) (<sup>68</sup>Ga-HBED-PSMA-PET/CT)	rzjhirrzjh(qcnuwkhuqt) = rkysibqriu zkobzskqxo (jikponyinu )	-	20 May 2015
				<sup>68</sup>Gallium-labelled ligand of prostate-specific membrane antigen (<sup>68</sup>Ga-HBED-PSMA) (<sup>68</sup>Ga-HBED-PSMA-PET/MR)	rzjhirrzjh(qcnuwkhuqt) = fmuhpbwijt zkobzskqxo (jikponyinu )