DermaVir Patch: A DNA Vaccine To Follow

[John2038]

DermaVir Patch is the Genetic Immunity's candidate Nanomedicine Vaccine designed for HIV-specific immune reconstitution. The Antiviral Mechanism of Action is based on inhibition of viral replication by cytotoxic killing of HIV-infected cells. Currently, there are no approved immune therapy or vaccine products on the market for HIV/AIDS.


Genetic Immunity, InPlay: Second Phase II Clinical Trial Commences in Italy on Company's Lead Product Candidate DermaVir Patch HIV Vaccine
Apr 16, 2009

This Phase II, randomized, placebo-controlled trial is designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific memory T cells in HIV-1-infected individuals, and whether the quantity of these memory T cells correlate with the viral load set point following analytical treatment interruption (ATI). Subjects are being randomized to receive either DermaVir Patch (8 subjects per cohort) or Placebo Patch (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. The trial will employ a novel assay of memory T-cell function known as the PHPC (Precursors with High Proliferative Capacity) assay developed by ViroStatics, srl, the Italian partner of Genetic Immunity.

"I look forward to obtaining results from this, our second in-progress Phase II trial for DermaVir. I believe results will be outstanding and closely correlate with those of our first Phase II trial underway in Germany and allow us to quickly move forward to Phase III in the not too distant future. When successful, DermaVir can become the first effective HIV immune-based treatment on the market within the next few years," commented Julianna Lisziewicz, CEO of Genetic Immunity.

"The trial has the potential to indicate biomarkers of immune control of HIV. We are very glad we can test the hypothesis by employing DermaVir, one of the best immune-based product candidates available," added Franco Lori, Protocol Chair of the Trial.

A total of 16 subjects will be enrolled and randomized to receive DermaVir Patch (8 subjects) or DermaVir Patch Placebo (8 subjects). As of the date of this press release three patients have already been enrolled.

For more information please visit the Company's official website at http://www.geneticimmunity.com or contact Zsolt Lisziewicz directly at +3612720364

Source


Clinical Trials involving DermaVir Patch, 2009

Location (clinicaltrials.gov ID)	Title	Status
GIHU004 Hungary (NCT00712530) To read Study Synopsis click here...	A Phase I Study to Evaluate the Tolerability and Safety of DermaVir Immune Therapy in HIV-infected Subject under Treatment with HAART	Excellent safety, tolerability, and immunogenicity: DermaVir evoked long-lasting gag-specific T cells 6- to 18,000 fold above pre-treatment values in all nine patients, in dose dependent manner.
ACTG 5176 USA (NCT00270205) To read Study Synopsis click here...	A Phase I/II, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of DermaVir Patch Immune Therapy in HIV-infected Subjects Currently Under Treatment with HAART	24 of the 24 patients enrolled, the trial is still blinded.
GIEU006 Germany (NCT00711230) To read Study Synopsis click here...	A Phase II, Randomized, Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of DermaVir Patch Immune Therapy in HIV-1 Infected treatment-nadve Subjects	33 of the 36 patients are enrolled. Trial so far shows excellent safety and tolerability, still blinded for efficacy.
PHPC-02 Italy	Antiretroviral sparing concept: a Phase II, randomized, single blind placebo controlled study to investigate the effect of DermaVir immunization on the quantity of HIV-specific T cells during HAART followed by analytical treatment interruption	Enrollment of the 16 patients has been initiated. 3 of 16 patients are enrolled.
IMPAACT-P1049 USA	A Phase I/II study of the safety, tolerability and immunogenecity of a topical therapeutic DNA denritic cell vaccine (DermaVir Patch) in children, adolescents and young adults with hiv-1 infection on highly active antiretroviral therapy (HAART).	In preparation

Older News


Genetic Immunity, Retrospective: Next Generation DNA Vaccine - DermaVir nanomedicine for the Treatment of HIV/AIDS
Feb 26, 2009

"We have been developing the DermaVir Patch as our lead product candidate for the treatment of HIV/AIDS," Julianna Lisziewicz begins telling her Company's story. "The DermaVir Patch is the next generation of DNA vaccine patented for the treatment of chronic diseases.

Based on FDA classification, it is a combination of our new biologic product (DermaVir) and our new medical device (DermaPrep). DermaVir contains a novel plasmid DNA that encodes most, but not all HIV genes. It is administered topically using our DermaPrep medical device.

The discovery behind DermaVir began with clinical observations and extensive examinations of one particular patient known as the 'Berlin Patient.' He showed us that (i) induction of long-term immune control in HIV-positive individuals is feasible, and (ii) antiviral T-cells can control HIV replication in HIV-positive individuals.

Shortly after he become infected we treated the Berlin Patient with antiretroviral drugs, followed by two interruptions in his drug therapy, which resulted in controlled viral load rebounds. By Christmas of 1996, although he permanently interrupted his therapy, his viral load remained undetectable because his HIV-specific immune response was capable of killing virus infected cells. Blood tests showed that he developed gag-specific memory T-cell responses that were capable of controlling virus replication. To date, he has not resumed antiretroviral treatments, and his immune system still keeps viral replication in bay.

This initial observation, and subsequent primate studies, provided the rationale for our next generation nanomedicine-based immune therapy," added Dr. Lisziewicz, finishing the origins of Genetic Immunity's work.

"Proof of concept" for the immunological and antiviral activities of Genetic Immunity's product was demonstrated in infected macaques, some of them with advanced stages of AIDS. Analysis of data derived from these animal trials suggested that repeated DermaVir administration results in a cumulative strengthening of the antiviral immune response without adding significant toxicities or adverse effects.

Among all animal studies, the monkey model is thought to be superior to other commonly used animal
models (e.g., mice, rats, rabbits) because the disease's progression and response to treatments in macaques is very similar to the human disease.

Genetic Immunity believes that the DermaVir Patch has the potential to be the next generation of DNA vaccines designed to inhibit HIV replication by cytotoxic killing of HIV-infected cells. Currently, there are no approved immune therapy or nanomedicine products on the HIV market.

Source


Genetic Immunity Announces Data Related to the DermaVir Nanomedicine Patch in the Journal of Immunology
April 21, 2008

Genetic Immunity, a US/Hungarian clinical-stage company focused on patented nanomedicines for immune amplification, announced today that the Journal of Immunology published findings on a key biomarker currently being used in clinical studies of its lead HIV/AIDS nanomedicine candidate, the dermavir Patch. The paper, entitled "HIV-1-Specific T Cell Precursors with High Proliferative Capacity Correlate with Low Viremia and High CD4 Counts in Untreated Individuals" highlights data from a study conducted by Sandra Calarota, Ph.D., of the Research Institute for Genetic and Human Therapy (RIGHT).

In Dr. Calarota's study of 32 HIV-1 infected individuals, high immunological responses measured by a novel assay of T cell Precursors with High Proliferative Capacity (PHPC assay) better correlated with viral suppression and positive immunologic outcomes, than did the traditional ELISPOT assay.

These data further validate and support results from a clinical study of Genetic Immunity's dermavir patch presented in February 2008 at the 15th Annual Conference on Retroviruses and Opportunistic Infections (CROI). The study demonstrated that the dermavir patch induced a significant increase of PHPC counts in all 9 HIV-1-infected participants, suggesting that the DermaVir patch may promote a targeted amplification of the immune system capable of reducing the amount of circulating HIV virus.

Dr. Franco Lori, the lead author of the study said, "The correlation between high PHPC counts and low viral load in HIV-infected subjects suggests that the presence of a greater number of T-cells that have retained their ability to expand and function normally may be a better predictor of patient outcomes. This new PHPC assay may also be a valuable tool in the development and testing of urgently needed nanomedicines, immune therapies and prophylactic vaccines for a number of diseases in addition to HIV/AIDS."

Julianna Lisziewicz, Ph.D., Co-Founder and CEO of Genetic Immunity, said, "The design and testing of the dermavir patch has long focused on PHPCs as a marker. We see these results as validation that our approach has been scientifically sound.

Genetic Immunity is a US/Hungarian development stage biopharmaceutical company establishing leadership in Nanomedicines for immunity amplification. next-generation biopharmaceuticals. Nanomedicine, an offshoot of nanotechnology, refers to highly specific medical intervention at the molecular scale for curing disease or repairing damaged tissues, such as bone, muscle, or nerve. The Company is leveraging its proprietary immune amplification platform technology, Genetic Immunity aims to create new markets for infectious diseases, cancer and allergies through the discovery, development and commercialization of topically administered nanomedicines. These indications represent a significant unmet medical need and the potential for alternative treatment approaches. Genetic Immunity's founders discovered the lead product nanomedicine candidate, the DermaVir Patch for the treatment of HIV/AIDS. The DermaVir Patch is in Phase II clinical development and could be the first nanomedicine immune therapy approved for HIV-infected individuals. DermaVir Patch has demonstrated excellent safety, immunogenicity and antiviral efficacy in preclinical studies. Phase I/II trials to date have confirmed safety and tolerability and indicate the induction of long-lasting HIV-specific T cells.

Source

[veritas]

John,

This therapy seems to significantly control freeflowing virus.

http://www.hivandhepatitis.com/vaccines/013105_h.html

I found this article on Dermavir's preclinical results which  echoes the potential in vivo of the patch. Initially , I believe , researches thought Dermavir would have to be used in conjunction with ART. With the results of the phase ll study, they might have a therapeutic - like vaccine. Exciting stuff.

v

[siempre positivo]

good news. I hope to have news fast 

[John2038]

David Evans talked about Dermavir last Feb 09 here, and Richard Jeffreys was talking about it in Nov 01 here.

Good Job guys.

John

[sensual1973]

is this meant to be used in combination with other ART or solely as a therapeutic approach ?

[Matts]

Probably I can take part at this trial. The hope is, that Dermavier can replace ART for years or forever, but its not sure yet. The trial lasts 5 years, but they want to move forward soon if it works well.

Dr.Julianna Lisziewicz talks about Dermar and her NanoMedicineCluster :Link

J.Lisziewicz's cluster:Link