pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.)(pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.)) - 在研适应症：HPV相关癌症，HPV16感染，肿瘤转移_专利_临床

概要

基本信息

药物类型

DNA疫苗、治疗性疫苗

别名

靶点-

作用机制

免疫刺激剂

治疗领域

肿瘤感染

在研适应症

HPV相关癌症HPV16感染肿瘤转移

非在研适应症-

原研机构

佳揚生技

在研机构

佳揚生技

非在研机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.) 相关的临床试验

NCT06508138 / Enrolling by invitation临床1期IIT

A Phase I Clinical Trial Assessing the Safety and Immunologic Correlates of Heterologous Prime-Boost With pNGVL4a-Sig/E7(Detox)/HSP70 and TA-HPV in Healthy Donors Followed by Peripheral Blood Collection

This healthy related donor clinical trial is linked to a recipient clinical trial protocol for therapeutic purposes. In this healthy donor protocol, haploidentical relatives of a patient with recurrent or metastatic human papilloma virus (R/M HPV) 16-associated malignancy will be invited to be vaccinated with a therapeutic HPV vaccine series (PVX1) to generate HPV-specific white blood cells. In the linked recipient phase 1 clinical trial protocol, patient with incurable, locally recurrent or metastatic HPV 16-associated head and neck cancer will be randomized to one of two arms:
Arm A: non-myeloablative (NMA) allogeneic bone marrow transplant (alloBMT) OR Arm B: CD8-depleted donor lymphocyte infusion (DLI) on Day 0 of a dose escalation scheme
These two clinical trials are separated so that the healthy donor trial deals exclusively with issues of safety and immunological efficacy of the HPV vaccine series and this companion recipient trial examines the safety, feasibility and clinically efficacy of the allogeneic bone marrow graft and CD8-depleted DLI. The central hypothesis of the clinical trial is that patients with R/M HPV-associated malignancies can be safely and effectively treated by allogeneic bone marrow transplantation and/or CD8-depleted DLI from a healthy related donor that has been vaccinated against HPV16 E6 and E7 proteins.

开始日期2023-10-18

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT03911076 / Terminated临床2期

A Randomized Double-Blind, Placebo-controlled Phase II Trial With Safety Run-In of Intramuscular pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN for the Treatment of Patients With HPV16+ Atypical Squamous Cells of Undetermined Significance (ASC-US) or Cannot Exclude High Grade SIL (ASC-H) Cytology or Low-grade Squamous Intraepithelial Lesion (LSIL)

To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen
To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6

开始日期2019-05-22

申办/合作机构

佳揚生技

[+1]

NCT00988559 / Completed临床1期IIT

A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.

开始日期2009-09-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

100 项与 pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.) 相关的临床结果

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100 项与 pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.) 相关的转化医学

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100 项与 pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.) 相关的专利（医药）

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2

项与 pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.) 相关的文献（医药）

2023-04-03·Cancer Prevention Research

Safety Run-in of Intramuscular pNGVL4a-Sig/E7(detox)/HSP70 DNA and TA-CIN Protein Vaccination as Treatment for HPV16+ ASC-US, ASC-H, or LSIL/CIN1

Article

作者: Einstein, Mark H. ; Wu, T.C. ; Ferrall, Louise ; Chang, Yung-Nien ; Akin, Mark ; Roden, Richard B.S. ; Blomer, Allison

AbstractPatients with human papillomavirus type 16 (HPV16) infection and low-grade cervical dysplasia [low-grade squamous intraepithelial lesion (LSIL)/CIN1] or atypical squamous cells [atypical squamous cells of undetermined significance (ASC-US)/atypical squamous cells- cannot exclude high-grade squamous intraepithelial lesion (ASC-H)] require active surveillance for disease progression. A safe and effective immunotherapy to clear HPV16 is an unmet medical need. The safety run-in cohort of a randomized double-blind, placebo-controlled phase II trial of PVX2 [vaccination twice with HPV16-targeting pNGVL4a-Sig/E7(detox)/HSP70 plasmid and once with the HPV16 L2E7E6 fusion protein “TA-CIN”] as immunotherapy for patients with HPV16+ ASC-US, ASC-H, or LSIL/CIN1 (NCT03911076) was recently completed. The primary objective of this cohort was to determine the safety and tolerability of PVX2 vaccination. Subjects were confirmed to have HPV16 infection and LSIL/CIN1, ASC-US, or ASC-H. Adverse events were evaluated using Common Terminology Criteria for Adverse Events v5.0. HPV typing by HPV16 18/45 Aptima Assay was done at baseline, month 6, and month 12, with simultaneous cytology analysis. Cervical biopsies and endocervical curettage were performed at baseline and month 6. In the safety run-in cohort 12 eligible patients were enrolled. Each received three monthly immunizations. One was lost to follow-up after week 12. There were no serious adverse events. A total of five adverse events were noted by 4 patients; 4 were considered not vaccine-related, and one ‘unlikely related’ by the investigator. At month 6, 45% (5/11) of participants converted to HPV16-negative and 2 others developed CIN2+ and received a loop electrosurgical excision procedure. At month 12, 64% (7/11) were HPV16-negative, including those HPV16-negative at month 6. In conclusion, PVX2 immunotherapy was well tolerated and associated with viral regression, supporting further testing.Prevention Relevance:This safety run-in study cohort suggests that PVX2 immunotherapy is well tolerated in the target population and is sufficiently safe to warrant further clinical testing in a randomized study. The combined vaccines may facilitate higher-than-expected rate of human papillomavirus type 16 viral clearance 6 and 12 months after treatment, although this requires validation.

1990-04-01·International Journal of Sports Medicine4区 · 医学

Maximal Oxygen Uptake Relative to Plasma Volume Expansion

4区 · 医学

Article

作者: M. K. Hopper ; Edward F Coyle ; A. R. Coggan

Controversy exists as to whether plasma volume (PV) expansion has the potential to increase maximal oxygen uptake (VO2max). In the present study, VO2max and exercise time to fatigue were measured in nine untrained men when plasma volume (PV) was normal and then again on the next day following two levels of PV expansion. Resting PV was expanded (via intravenous infusion of a 6% dextran solution) by 282 +/- 16 ml (i.e., PVX-1) and then by 624 +/- 26 ml (i.e., PVX-2). PVX-1 increased stroke volume (CO2 rebreathing) during submaximal exercise by 15% (P less than 0.05) above normal levels. VO2max following PVX-1 was increased 4% (P less than 0.05; 3.78 to 3.92 l/min) despite a 4% reduction in hemoglobin concentration. Exercise time to fatigue was also increased (P less than 0.05). PVX-2 resulted in an 11% (P less than 0.05) reduction in hemoglobin concentration during maximal exercise and a return of VO2max and exercise time to normal levels. In summary, we have observed in untrained men that 200-300 ml of PV expansion increases SV, measured during submaximal exercise, yet causes only a small amount of hemodilution. As a result, VO2max is increased slightly and performance is improved. Further PV expansion to levels 500-600 ml above normal results in an excessive hemodilution and a subsequent decline in VO2max and performance to normal levels. There is an optimal PV for eliciting VO2max in untrained men which appears to be approximately 200-300 ml above their normal levels.

100 项与 pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN(Papivax Biotech, Inc.) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
乳头状瘤病毒感染	临床3期	美国	佳揚生技	2019-04-28
HPV相关癌症	临床1期	美国	佳揚生技	2023-10-18
HPV16感染	临床1期	美国	佳揚生技	2023-10-18
肿瘤转移	临床1期	美国	佳揚生技	2023-10-18

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00988559 (CTgov)	临床1期	宫颈上皮内瘤样病变 \| 人乳头瘤病毒 16 阳性	132	Gene gun vaccine+DNA vaccination (PMED Delivery - Groups 1 and 2)	襯築觸醖壓窪淵觸網憲(顧餘鏇網鹹鏇積範夢製) = 鬱獵鹹鹹鏇簾鬱壓範鑰餘簾淵齋壓膚繭範遞築 (願鏇顧顧壓餘鏇膚鏇膚, 憲艱襯簾鏇願選淵遞鹽 ~ 齋鹽構淵顧淵構製襯齋) 更多	-	2018-07-09
				therapeutic resection of the lesion+intramuscular vaccination+DNA vaccination (IM Injections - Groups 5 and 6)	襯築觸醖壓窪淵觸網憲(顧餘鏇網鹹鏇積範夢製) = 鹽醖簾壓窪願積觸膚衊餘簾淵齋壓膚繭範遞築 (願鏇顧顧壓餘鏇膚鏇膚, 簾選積願淵範衊襯觸積 ~ 積齋鹹窪構淵選醖築襯) 更多