Delving into the Latest Updates on DermaVir with Synapse

Overview

Basic Info

Drug Type

DNA vaccine, Therapeutic vaccine

Synonyms

DermaVir Patch, HIV DNA vaccine topical (Genetic Immunity), LC-002

+ [1]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV InfectionsAcquired Immunodeficiency Syndrome

Inactive Indication-

Originator Organization

Genetic Immunity, Inc.

Active Organization

Genetic Immunity, Inc.

Karolinska Institutet

Virostatics Srl

Inactive Organization

National Institute of Allergy & Infectious Diseases

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.

Start Date01 Nov 2012

Sponsor / Collaborator

Muhimbili University of Health & Allied Science Institute

[+5]

NCT00918840 / CompletedNot Applicable

Antiretroviral-Sparing Concept: An Exploratory Phase II, Randomized, Single Blind Placebo-Controlled Study to Investigate the Effect of Therapeutic Immunization on the Quantity of HIV-Specific T Cell Precursors During Highly Active Antiretroviral Therapy Followed by Analytical Treatment Interruption

PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load set point following analytical treatment interruption (ATI). Subjects will be randomized to receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.

Start Date01 Apr 2009

Sponsor / Collaborator

Genetic Immunity, Inc.

[+1]

NCT00711230 / CompletedPhase 2

A Phase II Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antiretroviral Activity of DermaVir Patch (LC002) in Treatment-Naïve HIV-1-Infected Patients

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.
GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

Start Date01 Apr 2008

Sponsor / Collaborator

Genetic Immunity, Inc.

[+1]

100 Clinical Results associated with DermaVir

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100 Translational Medicine associated with DermaVir

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100 Patents (Medical) associated with DermaVir

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18

Literatures (Medical) associated with DermaVir

01 Dec 2013·Journal of acquired immune deficiency syndromes (1999)Q3 · MEDICINE

Safety, Tolerability, and Immunogenicity of Repeated Doses of DermaVir, a Candidate Therapeutic HIV Vaccine, in HIV-Infected Patients Receiving Combination Antiretroviral Therapy

Q3 · MEDICINE

Article

Author: Spritzler, John ; Rinaldo, Charles R. ; Lori, Franco ; Rodriguez, Benigno ; Tenorio, Allan R. ; Lisziewicz, Julianna ; Li, Xiao-Dong ; Mailliard, Robbie B. ; Pollard, Richard B. ; Jacobson, Jeffrey M. ; Asmuth, David M. ; Yesmin, Suria ; Martinez, Ana I. ; Matining, Roy M.

BACKGROUND:

HIV-specific cellular immune responses are associated with control of viremia and delayed disease progression. An effective therapeutic vaccine could mimic these effects and reduce the need for continued antiretroviral therapy. DermaVir, a topically administered plasmid DNA-nanomedicine expressing HIV (CladeB) virus-like particles consisting of 15 antigens, induces predominantly central memory T-cell responses.

METHODS:

Treated HIV-infected adults (HIV RNA <50 and CD4 >350) were randomized to placebo or escalating DermaVir doses (0.1 or 0.4 mg of plasmid DNA at weeks 1, 7, and 13 in the low- and intermediate-dose groups and 0.8 mg at weeks 0, 1, 6, 7, 12, and 13 in the high-dose group), n = 5-6 evaluable subjects per group. Immunogenicity was assessed by a 12-day cultured interferon-γ enzyme-linked immunosorbent spot assay at baseline and at weeks 9, 17, and 37 using 1 Tat/Rev and 3 overlapping Gag peptide pools (p17, p24, and p15).

RESULTS:

Groups were comparable at baseline. The study intervention was well tolerated, without dose-limiting toxicities. Most responses were highest at week 17 (4 weeks after last vaccination) when Gag p24 responses were significantly greater among intermediate-dose group compared with control subjects [median (IQR): 67,600 (5633-74,368) versus 1194 (9-1667)] net spot-forming units per million cells, P = 0.032. In the intermediate-dose group, there was also a marginal Gag p15 response increase from baseline to week 17 [2859 (1867-56,933), P = 0.06], and this change was significantly greater than in the placebo group [0 (-713 to 297), P = 0.016].

CONCLUSIONS:

DermaVir administration was associated with a trend toward greater HIV-specific, predominantly central memory T-cell responses. The intermediate DermaVir dose tended to show the greatest immunogenicity, consistent with previous studies in different HIV-infected patient populations.

01 Jan 2013·Nanomedicine : nanotechnology, biology, and medicineQ2 · MEDICINE

Nanomedicine applications towards the cure of HIV

Q2 · MEDICINE

Review

Author: Enikő R. Tőke ; Julianna Lisziewicz

FROM THE CLINICAL EDITOR:

Despite the leaps and bounds in the development of antiretroviral therapy, HIV remains a significant public health challenge. In this review, applications of nanomedicine- based technologies are discussed in the context of HIV treatment, including virus elimination by activation of latently infected CD4+ T-cells; infected cell elimination in the reservoirs by boosting HIV-specific T cells, and by preventing infection by the use of microbicides with improved epithelial penetration and drug half-life.

01 May 2012·Nanomedicine : nanotechnology, biology, and medicineQ2 · MEDICINE

Structure and biological activity of pathogen-like synthetic nanomedicines

Q2 · MEDICINE

Article

Author: Jack F. Douglas ; Eszter Somogyi ; Orsolya Lőrincz ; János Szebeni ; Ferenc Horkay ; Enikő R. Tőke ; Julianna Lisziewicz ; Preethi L. Chandran

FROM THE CLINICAL EDITOR:

The authors investigated DermaVir nanomedicine comprised of pathogen-like pDNA/PEIm nanoparticles with structure and function resembling spherical viruses. DermaVir delivery of pDNA expresses antigens that induce immune responses to kill HIV infected cells.

100 Deals associated with DermaVir

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	US	National Institute of Allergy & Infectious Diseases	01 Jan 2006
Acquired Immunodeficiency Syndrome	Phase 1	DE	Genetic Immunity, Inc.	30 Jan 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00712530 (GIHU004, CTgov)	Phase 1	HIV Infections	9	DermaVir (Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization)	iligvyiktj(ztybvwwbtw) = mwvlmynbgx faydefqjtl (phinqhpmpx, rvdpglyllo - lcvesaklqw) View more	-	26 Mar 2013
				DermaVir (Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization)	iligvyiktj(ztybvwwbtw) = iznwfrvpsk faydefqjtl (phinqhpmpx, fyjuqtkmif - nasrzbloei) View more
NCT00270205 (CTgov)	Phase 1/2	HIV Infections	28	LC002 high-dose vaccination (C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13)	nyqagqocra(brpzfcabdw) = ksblmgiuqr isnkxxcddm (sbwmftznhf, yhaadolfpu - ondhwmysni) View more	-	13 Oct 2011
				LC002 high-dose vaccination (E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13)	nyqagqocra(brpzfcabdw) = fuqnnthtez isnkxxcddm (sbwmftznhf, hosktywhmt - shhexkkcye) View more
ACTG protocol A5176 (IAS2011)	Not Applicable	HIV Infections	-	DermaVir	gnnfpellmy(qppqecvesk) = znxwdismrr kdwsvemdkz (exxxoxxfwn ) View more	-	01 Jan 2011
				Placebo	gnnfpellmy(qppqecvesk) = hxilgtshzv kdwsvemdkz (exxxoxxfwn ) View more
NCT00711230 (GIEU006, IAS2010)	Phase 2	HIV Infections	36	DermaVir Patch 0.4 mg	nkbunvucqo(ikxkdvjzvi) = did not change obaqhvftwr (istfikisyq ) View more	-	01 Jan 2010
				Placebo