Delving into the Latest Updates on Topsalysin with Synapse

Overview

Basic Info

Drug Type

Recombinant protein

Synonyms

+ [1]

Target-

Action

stimulants, modulators

Mechanism

Apoptosis stimulants, Cell membrane modulators

Therapeutic Areas

Other Diseases

Active Indication

Lower Urinary Tract Symptoms

Inactive Indication

Prostatic CancerProstatic HyperplasiaRecurrent Prostate Carcinoma

Originator Organization

Sophiris Bio, Inc.

Active Organization

Kissei Pharmaceutical Co., Ltd.

Inactive Organization

Sophiris Bio, Inc.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 116237

Source: *****

A Multi-Centre, Open Label, Phase IIb Study, Evaluating the Safety, Tolerability and Efficacy of Targeted Intraprostatic Administration of PRX302 to Treat Men with Histologically Proven, Clinically Significant, Localised, Low- to Intermediate-Risk Prostate Cancer that is Associated with an MRI Lesion - Intraprostatic PRX302 injection to treat localised prostate cancer

Start Date03 Feb 2017

Sponsor / Collaborator-

NCT02499848

/ CompletedPhase 2

Phase IIa Study, Evaluating the Safety and Tolerability of Targeted Intraprostatic Administration of PRX302 With Histologically Proven,Clinically Significant Localised, Low to Intermediate Risk Prostate Cancer Associated With MRI Lesion

To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.

Start Date01 Jul 2015

Sponsor / Collaborator

Sophiris Bio, Inc.

100 Clinical Results associated with Topsalysin

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100 Translational Medicine associated with Topsalysin

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100 Patents (Medical) associated with Topsalysin

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19

Literatures (Medical) associated with Topsalysin

01 Jun 2022·Aktuelle UrologieQ4 · MEDICINE

Minimal-invasive Therapie: Wie ist der Stand im Jahre 2021 – was kommt, was geht

Q4 · MEDICINE

Article

Author: Franz, Julia ; Miernik, Arkadiusz ; Gratzke, Christian

01 Nov 2020·Molecular Cancer TherapeuticsQ2 · MEDICINE

Microparticle Encapsulation of a Prostate-targeted Biologic for the Treatment of Liver Metastases in a Preclinical Model of Castration-resistant Prostate Cancer

Q2 · MEDICINE

Article

Author: Brennen, W. Nathaniel ; Joshi, Nitin ; Zheng, Lei ; Lan, Haoyue ; Levy, Oren ; Karp, Jeffrey M. ; Dalrymple, Susan L. ; Rosen, D. Marc ; Ranganath, Sudhir H. ; Simons, Brian W. ; Isaacs, John T. ; Rogers, Oliver C. ; Denmeade, Samuel R. ; Kuang, Heidi ; Antony, Lizamma ; Pickering, Andrew ; Howard, S. Peter

AbstractPRX302 is a highly potent, mutant bacterial pore-forming biologic protoxin engineered for selective activation by PSA, a serine protease expressed by benign and malignant prostate epithelial cells. Although being developed as a local therapy for benign prostatic hyperplasia and localized prostate cancer, PRX302 cannot be administered systemically as a treatment for metastatic disease due to binding to ubiquitously expressed glycosylphosphatidylinositol (GPI)-anchored proteins, which leads to poor accumulation within the tumor microenvironment. To overcome this limitation, poly-lactic-co-glycolic acid (PLGA) microparticles encapsulating the protoxin were developed, which are known to accumulate in the liver, a major site of metastasis for prostate cancer and other solid tumors. A highly sensitive and reproducible sandwich ELISA to quantify PRX302 released from microparticles was developed. Utilizing this assay, PRX302 release from different microparticle formulations was assessed over multiple days. Hemolysis assays documented PSA-dependent pore formation and lytic potential (i.e., function) of the released protoxin. MTT assays demonstrated that conditioned supernatant from PRX302-loaded, but not blank (i.e., unloaded), PLGA microparticles was highly cytotoxic to PC3 and DU145 human prostate cancer cells in the presence of exogenous PSA. Microparticle encapsulation prevented PRX302 from immediately interacting with GPI-anchored proteins as demonstrated in a competition assay, which resulted in an increased therapeutic index and significant antitumor efficacy following a single dose of PRX302-loaded microparticles in a preclinical model of prostate cancer liver metastasis with no obvious toxicity. These results document that PRX302 released from PLGA microparticles demonstrate in vivo antitumor efficacy in a clinically relevant preclinical model of metastatic prostate cancer.

01 May 2018·Current Opinion in Urology

Investigational procedures in benign prostatic hypertrophy

Review

Author: Acquaye, Joseph ; Borofsky, Michael S

PURPOSE OF REVIEWAs benign prostatic hypertrophy (BPH) becomes a more common disease, there has been a dramatic rise in the number of investigational procedures being developed to manage it. We seek to present an overview of the most recently developed treatments and present clinical data related to application wherever available.RECENT FINDINGSAs a greater number of treatments become available for BPH, improved diagnostic testing could prove beneficial in helping guide patient selection. Efforts are underway to identify serum biomarkers associated with BPH as well as new classifications strategies, specifically with MRI, to determine both the anatomy of BPH as well as its histologic distribution. Outpatient-based procedures for BPH currently being developed include the temporary implantable nitinol device as well as intraprostatic injections such as Botox and PRX302. Aquablation is a novel technique that uses robotically guided high-pressured saline to ablate prostate tissue. Early data suggests noninferiority compared with TURP. Finally, efforts are underway to apply robotics to BPH with the advent of a robotic transurethral platform being designed for prostate enucleation.SUMMARYMany new techniques are poised to be introduced to the BPH market over the coming years. The unique risk/benefit profiles as well as associated clinical outcomes of each will need to be studied in detail in order to help identify proper roles in the management of patients with symptomatic disease.

1

News (Medical) associated with Topsalysin

15 Jan 2008

·www.biospace.com

Protox Therapeutics Inc. Initiates Phase 2 Prostate Cancer Study

VANCOUVER, Jan. 15 /CNW/ - Protox Therapeutics Inc. (TSX-V:PRX), a leader in the development of targeted therapeutic proteins, today announced that the Company has received Institutional Review Board (IRB) approvals to proceed with its Phase 2a clinical trial evaluating PRX302 for the treatment of localized recurrent prostate cancer. Activities associated with patient screening have commenced and the Company expects to enroll the first patient in the first quarter of 2008.

100 Deals associated with Topsalysin

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05160

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 3	United Kingdom	Sophiris Bio, Inc.	01 Jul 2015
Prostatic Hyperplasia	Phase 3	Canada	Sophiris Bio, Inc.	01 Oct 2013
Prostatic Hyperplasia	Phase 3	Australia	Sophiris Bio, Inc.	01 Oct 2013
Prostatic Hyperplasia	Phase 3	Ukraine	Sophiris Bio, Inc.	01 Oct 2013
Prostatic Hyperplasia	Phase 3	United States	Sophiris Bio, Inc.	01 Oct 2013
Prostatic Hyperplasia	Phase 3	Russia	Sophiris Bio, Inc.	01 Oct 2013
Prostatic Hyperplasia	Phase 3	New Zealand	Sophiris Bio, Inc.	01 Oct 2013
Recurrent Prostate Carcinoma	Phase 3	United States	Sophiris Bio, Inc.	01 Feb 2008
Lower Urinary Tract Symptoms	Phase 3	-	Kissei Pharmaceutical Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AUA2016	Phase 3	Prostatic Hyperplasia	479	PRX302	(denofutytl) = lyhfutnwnd tclphcqbbo (hwpqkifvjv )	Positive	01 Apr 2016
NCT01966614 (PLUS-1, Biospace) Manual	Phase 3	Prostatic Hyperplasia	479	Topsalysin	(uybxyohxjg) = iqemzitoay vkixtjzssy (gpqwqridqj ) View more	Positive	10 Nov 2015
NCT01966614 (PLUS-1, Biospace) Manual	Phase 3	Prostatic Hyperplasia	479	Vehicle	(uybxyohxjg) = csnjvmhiqx vkixtjzssy (gpqwqridqj ) View more	Positive	10 Nov 2015
1787 (AUA2010)	Phase 1/2	Prostatic Hyperplasia PSA	-	PRX302	kycszwnzeq(fmegidbafs) = zgxlbetqig kgvffvaswd (hagdqrbucg )	-	01 Apr 2010

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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