Delving into the Latest Updates on Recombinant Human Ad-p53 with Synapse

Overview

Basic Info

Drug Type

Gene therapy

Synonyms

Gendicine, Recombinant Ad-p53 anti-cancer injection, p53 gene therapy

+ [6]

Target

p53

Mechanism

p53 stimulants(Tumor protein p53 stimulants)

Therapeutic Areas

NeoplasmsMouth and Tooth DiseasesOtorhinolaryngologic Diseases

Active Indication

Nasopharyngeal Neoplasms

Inactive Indication-

Originator Organization

Shenzhen SiBiono GeneTech Co. Ltd.

Active Organization

Shenzhen SiBiono GeneTech Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (20 Jan 2004),

Nasopharyngeal Neoplasms

Regulation-

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ObjectiveCervical cancer remains a major health concern globally, and combined modality treatment often includes radiotherapy or concurrent chemoradiotherapy. Recently, recombinant human adenovirus-p53 (rAd-p53) has been introduced as a promising agent in treatment of cervical cancer.MethodsWe conducted a systematic review and meta-analysis following the PRISMA guidelines. RCTs were identified through electronic databases without limitations on time or language. The studies should include patients diagnosed with cervical cancer receiving either rAd-p53 combined with radiotherapy or concurrent chemoradiotherapy (RT/CRT) or RT/CRT alone. Primary outcome measures were complete response rate (CRR) and objective response rate (ORR), as defined by WHO's criteria for solid tumor therapeutic evaluation. Secondary outcome measures included adverse reaction incidence.ResultsWe included 9 RCTs in the analysis. Meta-analysis revealed that rAd-p53 combined with radiotherapy or concurrent chemoradiotherapy significantly improved the CRR [OR = 1.67, 95%CI (1.29, 2.16), P < .0001] and ORR [OR = 1.26, 95%CI (1.15,1.37), P < .001] compared to radiotherapy or concurrent chemoradiotherapy alone. The incidence of fever was higher in the combination therapy group [OR = 2.80, 95%CI (1.40, 5.62), P < .001], but no significant differences were observed in the incidence of other adverse reactions.ConclusionsThe combination of rAd-p53 with radiotherapy or concurrent chemoradiotherapy exhibits enhanced therapeutic efficacy in the treatment of cervical cancer without a significant increase in severe adverse reactions. However, multicenter, large-scale, randomized clinical trials are warranted for further validation.

01 Jul 2024·Genes & Diseases

Twenty years of Gendicine® rAd-p53 cancer gene therapy: The first-in-class human cancer gene therapy in the era of personalized oncology

Review

Author: He, Tongchuan ; Qi, Li ; Li, Guiqing ; Wang, Hongwei ; Li, Jingjing ; Li, Peipei ; Fang, Xiaolong

Genetic mutations in TP53 contribute to human malignancies through various means. To date, there have been a variety of therapeutic strategies targeting p53, including gene therapy to restore normal p53 function, mutant p53 rescue, inhibiting the MDM2-p53 interaction, p53-based vaccines, and a number of other approaches. This review focuses on the functions of TP53 and discusses the aberrant roles of mutant p53 in various types of cancer. Recombinant human p53 adenovirus, trademarked as Gendicine, which is the first anti-tumor gene therapy drug, has made tremendous progress in cancer gene therapy. We herein discuss the biological mechanisms by which Gendicine exerts its effects and describe the clinical responses reported in clinical trials. Notably, the clinical studies suggest that the combination of Gendicine with chemotherapy and/or radiotherapy may produce more pronounced efficacy in slowing tumor growth and progression than gene therapy/chemotherapy alone. Finally, we summarize the methods of administration of recombinant human p53 adenovirus for different cancer types to provide a reference for future clinical trials.

13 Jun 2023·ACS omega

Emergence of Small Interfering RNA-Based Gene Drugs for Various Diseases.

Review

Author: Kurakula, Harshini ; Vaishnavi, Swetha ; Ellipilli, Satheesh ; Sharif, Mohammed Yaseen

Small molecule, peptide, and protein-based drugs have been developed over decades to treat various diseases. The importance of gene therapy as an alternative to traditional drugs has increased after the discovery of gene-based drugs such as Gendicine for cancer and Neovasculgen for peripheral artery disease. Since then, the pharma sector is focusing on developing gene-based drugs for various diseases. After the discovery of the RNA interference (RNAi) mechanism, the development of siRNA-based gene therapy has been accelerated immensely. siRNA-based treatment for hereditary transthyretin-mediated amyloidosis (hATTR) using Onpattro and acute hepatic porphyria (AHP) by Givlaari and three more FDA-approved siRNA drugs has set up a milestone and further improved the confidence for the development of gene therapeutics for a spectrum of diseases. siRNA-based gene drugs have more advantages over other gene therapies and are under study to treat different types of diseases such as viral infections, cardiovascular diseases, cancer, and many more. However, there are a few bottlenecks to realizing the full potential of siRNA-based gene therapy. They include chemical instability, nontargeted biodistribution, undesirable innate immune responses, and off-target effects. This review provides a comprehensive view of siRNA-based gene drugs: challenges associated with siRNA delivery, their potential, and future prospects.

100 Deals associated with Recombinant Human Ad-p53

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Recombinant Human Ad-p53	L01XX	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Nasopharyngeal Neoplasms	CN	Shenzhen SiBiono GeneTech Co. Ltd.	20 Jan 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01574729 (Pubmed) Manual	Phase 2	Non-Small Cell Lung Cancer	163	Surgery+Recombinant Human Ad-p53	(mqerprauxl) = iypwpogche qkacfqzofp (cvrpmmiwba ) View more	Positive	06 Nov 2017
				Surgery	(mqerprauxl) = gtkqgvwwjb qkacfqzofp (cvrpmmiwba ) View more
ASCO2017	Not Applicable	Thyroid Cancer	82	rAd-p53 injection combined with radiotherapy and surgery	(lyaygsujqm) = qacchvhwlx aibrcasvmz (mofcnfqcnx ) View more	Positive	30 May 2017
				Surgery only	(lyaygsujqm) = xcvrzuzenb aibrcasvmz (mofcnfqcnx ) View more
Pubmed \| Hum Gene Ther	Not Applicable	Locally Advanced Cervical Carcinoma	69	rAd-p53 transfer combined with radiotherapy (group PRT)	(oljmuequny): HR = 0.551 (95% CI, 0.278 - 1.095), P-Value = 0.084 View more	Positive	01 Dec 2016
				radiotherapy alone (group RT)
ASCO2015	Not Applicable	Recurrent Uterine Sarcoma	21	rAd-p53 combined with chemotherapy	kaublklskj(vfigsgmnaq) = xoysqogglu nlekjydinb (nuzarskbmh ) View more	Positive	20 May 2015
				chemotherapy only	kaublklskj(vfigsgmnaq) = egxaurcgjg nlekjydinb (nuzarskbmh ) View more
ASCO2015	Not Applicable	Nasopharyngeal Carcinoma	30	Gendicine	(syuednuxlf) = rjvuwnuwbz bamvabsmyi (iiboiulvnj ) View more	-	20 May 2015
ASCO2014	Not Applicable	Sarcoma	37	Recombinant human adenovirus p53 (rAd-p53)	jwxtzigqqc(huruoljokm) = humsehcdjl cswdqthwzs (dgkgizbrps ) View more	Positive	20 May 2014
ASCO2013	Not Applicable	Malignant ascites \| Malignant Pleural Effusion	32	recombinant adenoviral human p53 gene (rAd-p53)	(sljfxvfdxr) = ryuyxzkqfz tkbgozopqa (tvscbdqdir ) View more	Positive	20 May 2013
ASCO2013	Not Applicable	Laryngeal Neoplasms	61	Recombinant adenoviral human p53 gene (No treatment)	dibcomvcvx(aiwewltowt) = pgnqelhoyi bzejlarkjw (gwkkyacxmt ) View more	Positive	20 May 2013
				rAd-p53 + radio- and chemo-therapy	dibcomvcvx(aiwewltowt) = nbxyozflva bzejlarkjw (gwkkyacxmt ) View more
ASCO2012	Phase 2	Mouth Neoplasms	-	Group I (rAd-p53 plus chemotherapy)	(zriwefrceq) = hgrwbbleel tslibtjfoj (memzmderdn ) View more	-	20 May 2012
				recombinant adenoviral human p53 gene (Group II (rAd-p53))	(zriwefrceq) = ovtlmzqndp tslibtjfoj (memzmderdn ) View more
ASCO2012	Not Applicable	Sarcoma	30	recombinant adenovirus human p53 gene (rAdp53 combined with hyperthermia and radiation)	ypjrwonbnu(qdlzjtzxft) = votypgsdwd fnvqjzrkbm (jkmlfcxpvk ) View more	Positive	20 May 2012