bizalimogene ralaplasmid (VGX-3100) / Inovio 
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 12 Diseases   2 Trials   2 Trials   97 News 
  • ||||||||||  Review, Journal:  A Review of Clinical Trials of Cancer and Its Treatment as a Vaccine. (Pubmed Central) -  Nov 13, 2023   
    This brief discussion of vaccines and their varieties with examples also discusses vaccine clinical trials in relation to cancer diseases in this DNA and RNA-based cancer vaccine that has had successful clinical trials like the cervical cancer drug VGX-3100, the kidney cancer drug Pembrolizumab, MGN-1601, the prostate cancer drug pTVG-HP with rhGM-CSF, the melanoma cancer drug proteasome siRNA, and the lung cancer drug FRAME-001.
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Trial completion date, Trial primary completion date:  VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) -  Jun 7, 2023   
    P2,  N=80, Recruiting, 
    This brief discussion of vaccines and their varieties with examples also discusses vaccine clinical trials in relation to cancer diseases in this DNA and RNA-based cancer vaccine that has had successful clinical trials like the cervical cancer drug VGX-3100, the kidney cancer drug Pembrolizumab, MGN-1601, the prostate cancer drug pTVG-HP with rhGM-CSF, the melanoma cancer drug proteasome siRNA, and the lung cancer drug FRAME-001. Trial completion date: May 2024 --> Sep 2029 | Trial primary completion date: May 2024 --> Sep 2029
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Review, Journal:  Therapeutic DNA Vaccines against HPV-Related Malignancies: Promising Leads from Clinical Trials. (Pubmed Central) -  Mar 17, 2022   
    In 2014 and 2021, two nucleic-acid vaccine candidates named MAV E2 and VGX-3100 completed phase III clinical trials in Mexico and U.S., respectively, for patients with human papillomavirus (HPV)-related, high-grade squamous intraepithelial lesions (HSIL)...The major roadblocks to a highly efficacious and practical product remain challenging and can be classified into five categories: (i) getting the vaccines into the right cells for efficient expression and presentation of HPV antigens (fusion proteins or epitopes); (ii) having adequate coverage of oncogenic HPV types, beyond the current focus on HPV-16 and -18; (iii) directing immune protection to various epithelial niches, especially anogenital mucosa and upper aerodigestive tract where HPV-transformed cells wreak havoc; (iv) establishing the time window and vaccination regimen, including dosage, interval and even combination therapy, for achieving maximum efficacy; and (v) validating therapeutic efficacy in patients with poor prognosis because of advanced, recurrent or non-resectable malignancies. Overall, the room for improvements is still large enough that continuing efforts for research and development will very likely extend into the next decade.
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Enrollment closed:  REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) -  Jan 11, 2022   
    P3,  N=203, Active, not recruiting, 
    Clinical implementation of DNA therapeutic vaccines into treatment regimen as a sole approach or in combination with conservative treatment holds great potential for effective cancer treatment. Recruiting --> Active, not recruiting
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Journal:  Durability of response to VGX-3100 treatment of HPV16/18 positive cervical HSIL. (Pubmed Central) -  Jul 7, 2021   
    In women with cervical HSIL who responded to VGX-3100 and were able to avoid surgery, clinical outcomes were comparable to the placebo control group which underwent conventional surgical treatment. These findings extend the understanding of the durability of the treatment effect of VGX-3100 up to 1.5 y and support that VGX-3100 could be used as an alternative to surgery.
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Clinical, Journal:  Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population. (Pubmed Central) -  Jun 22, 2021   
    The primary endpoint was met with 89.9% of RF recipients and 97.2% of FF recipients reaching a ≥2-fold rise in SFU/10 PBMC, 2 weeks following the last dose; RF was statistically non-inferior to FF (p = .022).A systemic, immunologic approach has the potential to fill a critical gap in the ability to treat men and women with high grade HPV diseases. These safety and immunogenicity data are supportive of the continued development of a refrigerated formulation of VGX-3100.
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Trial completion date, Trial primary completion date:  VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) -  Feb 25, 2021   
    P2,  N=80, Recruiting, 
    Trial completion date: May 2021 --> Aug 2022 | Trial primary completion date: Apr 2021 --> Jul 2022 Trial completion date: Sep 2021 --> Aug 2022 | Trial primary completion date: Jan 2021 --> Aug 2022
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Enrollment closed:  REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) -  Jul 24, 2019   
    P3,  N=200, Active, not recruiting, 
    Consequently, these analyses indicate that certain immunologic responses associate with successful resolution of HPV-induced pre-malignancy, with particular emphasis on the upregulation of perforin in the immunotherapy induced immune response. Recruiting --> Active, not recruiting
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Trial completion date, Trial primary completion date:  REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) -  Mar 8, 2019   
    P3,  N=198, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Aug 2020 --> Apr 2021 | Trial primary completion date: Aug 2019 --> Apr 2020
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Trial completion date, Trial primary completion date:  REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) -  Mar 7, 2019   
    P3,  N=198, Not yet recruiting, 
    Trial completion date: Aug 2020 --> Apr 2021 | Trial primary completion date: Aug 2019 --> Apr 2020 Trial completion date: Dec 2020 --> May 2021 | Trial primary completion date: Dec 2020 --> Apr 2021
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Trial completion date, Trial primary completion date:  REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) -  Nov 24, 2018   
    P3,  N=198, Not yet recruiting, 
    Trial completion date: Dec 2020 --> May 2021 | Trial primary completion date: Dec 2020 --> Apr 2021 Trial completion date: Mar 2021 --> Dec 2020 | Trial primary completion date: Mar 2021 --> Dec 2020
  • ||||||||||  bizalimogene ralaplasmid (VGX-3100) / Inovio
    Enrollment open, Trial primary completion date:  VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) -  Sep 24, 2018   
    P2,  N=80, Recruiting, 
    Trial completion date: Mar 2021 --> Dec 2020 | Trial primary completion date: Mar 2021 --> Dec 2020 Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2020 --> Jan 2021