VIRxSYS (VRX496) News

[John2038]

WHAT:   

        VIRxSYS to present data on its first clinical trial using
        lentiviral vectors in a presentation entitled Findings from
        Phase I/II and decisions regarding next step. The presentation
        will address the following:
        -- Successful delivery of a 937 base antisense sequence to HIV
        envelope
        -- Cumulative data on patient safety monitoring
        -- Coordination between manufacturing and clinical through the phases
        -- The next clinical trial: Phase IIb or phase III? Discussions with
        the regulator
        -- Defining the optimum patient population
        -- Re-imbursement models
WHY:   

        VIRxSYS' novel lentiviral vector platform and ongoing clinical
        trials show great promise in a safe and effective treatment for
        people with HIV. The company's gene therapy treatment, VRX496, can
        be replicated on a larger scale and is encouraging as a means to
        suppress and block HIV. To date, VRX496 has been administered in
        61 patients, representing an accumulative patient safety
        monitoring of 142 patient years. VRX496 is different from previous
        gene therapies because it uses a lentiviral vector derived from
        HIV-1 itself.

WHO:   

        VIRxSYS EVP of scientific and clinical affairs, Gerard J.
        McGarrity, PhD. Dr. McGarrity has over 20 years experience in
        the biotechnology industry and has authored more than 160
        scientific publications.

WHERE: 

        The 2009 Phaciliate Cell & Gene Therapy Forum, The Grand Hyatt
        Hotel, Washington, D.C.

WHEN:   
        Monday, January 26, 2009. VIRxSYS presentation will be held in Focus
        Session 2 at 2:55 p.m.


SOURCE: VIRxSYS

[John2038]

VRX496 Update, Novel HIV Gene Therapy
 
 
VIRxSYS Announces Completion of Phase I Study of VRX496, Novel HIV ...
 
The viral vector plus antisense is called VRX496. The antisense genetic medicine blocks HIV replication in CD4 T cells, which would otherwise be destroyed ...
www.natap.org/2005/newsUpdates/050505-01.htm
 
HIV gene therapy study 'shows promise'
The researchers are now recruiting for a second trial of the treatment - dubbed VRX496. This time it will be tested on patients whose HIV load is already ...
www.natap.org/2006/newsUpdates/110906_03.htm




















Source

[Alefou]

I was reading this ting and I think it's very encouraging. When I look on the clinical trial website, the trial is was scheduled to end on March 2009 ....

Let's wait for the results 

[xman]

There's a phase I/II trial ending now. I hope we will have some results very soon! This one of the most promising trials since it is in advanced phases.

http://clinicaltrials.gov/ct2/show/NCT00295477?term=VRX496&rank=2

Maybe they're waiting to finish all trials before releasing any results.

[riptide]

 I read somewhere on the net and of course I cant find the link.... VIRxSYS was moving into a phase II roll over study to follow up with some of the patients that received treatment in the I/II study. It didnt mention to many details from what I remember reading. Maybe the one XMAN is talking about.

[Inchlingblue]

At CROI 2009, which was in February 2009, they presented data from the trial and said it was "ongoing," so I'm hoping more data will be presented after the official completion of the trial , which was July 2009.

Penn Medicine presents HIV gene therapy trial data at CROI 2009

PHILADELPHIA – Researchers from Penn Medicine announced today the results from an ongoing Phase I/II
open label clinical trial of VRX496 at the 16th Conference on Retroviruses and Opportunistic Infections
(CROI) in Montreal. VRX496 is a gene therapy product being investigated for the treatment of HIV
infection. During the trial VRX496 was administered to twelve subjects prior to a controlled scheduled
treatment interruption (STI) from their current antiretroviral therapy.

"We continue to see the strong safety and tolerability profile that VRX496 demonstrated in the Phase I
clinical trials," said Carl June, MD, Professor of Pathology and Laboratory Medicine at Penn. "What we are
seeing now is the potential to generate a sustained immune system response in patients who have stopped taking their anti-retroviral regimens. Potentially this could lead to a shift in the treatment of HIV infection from trying to eradicate the HIV virus; which requires a daily regimen of pills and is ultimately a short-term solution because of the ability of HIV to mutate, to an approach where the body acquires immunity to HIV infection through a series of infusions."

The presentation "Safety, Antiviral Effect and Quantitative Measurement of Modified CD4+ T Cells
Trafficking to Gut Associated Lymphoid Tissue in a Phase I/II Open-label Clinical Trial Evaluative Multiple
Infusions of Lentiviral Vector-modified CD4+ T Cells Expressing Long env Antisense" was made by Pablo
Tebas, MD, at CROI 2009 on February 10th at 10 AM. Tebas is an Assistant Professor of Medicine at the
University of Pennsylvania School of Medicine.

"Multiple infusions of lentiviral-vector-modified cells appear to increase CD4+ counts and may decrease
viral load set point. We appear to have successfully reconstituted the CD4+ cell population in the gut with
VRX496 modified cells, which is a major site of HIV replication and suggests that the modified cells are
going where they need to go," said Pablo Tebas MD, Assistant Professor, University of Pennsylvania School
of Medicine. "The multiple infusions of lentiviral vector VRX496 with long antisense RNA appear to be safe,
and no serious adverse events were noted."

The results presented at CROI are from an ongoing Phase I/II trial of HIV-1 infected subjects fully
suppressed on Anti-Retroviral Treatments (ART). Patients received up to six infusions over 14 weeks. At
week 18 subjects interrupted their ART. Patients were monitored for adverse events, viral load, CD4+ T
cell count, vector-derived replication competent lentivirus (RCL) and immunogenicity, vector DNA
integration patterns, and TCR diversity.

LINK:

http://www.virxsys.com/media/.download_gallery/February%2010%20%202009.pdf

[tommy246]

That sounds great news if successful when could this become available

[xman]

If they start phase III trials in 2010 I guess 5-7 years and we will have it on the market. I guess the trials are long due to safety issues since gene therapy is a new approach and we know nothing about possible long term effects.

[Inchlingblue]

Here's an interesting Q&A about VRX496 from thebody;com:

LINK:

http://www.thebody.com/Forums/AIDS/Labs/Current/Q203264.html

[Inchlingblue]

VIRxSYS Announces at CROI Promising Results from Its HIV Vaccine Study

GAITHERSBURG, Md. - (Business Wire) VIRxSYS Corporation, a privately held company developing vaccines and RNA therapies for serious human diseases such as HIV and cardiovascular diseases, announced results from its prophylactic HIV vaccine (VRX1023) study in Rhesus Macaque monkeys during a presentation today at the 2010 Annual Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, CA. The study has demonstrated that the VIRXSYS vaccine, VRX1023, is capable of achieving significant control of viral load over the course of four months following a challenge with a highly pathogenic simian immunodeficiency virus (SIV), a virus found in non-human primates and similar to HIV. In addition, monkeys vaccinated with VRX1023 demonstrated an improved immune response. VIRxSYS is currently preparing an Investigational New Drug Application for the therapeutic use of their HIV vaccine candidate in HIV infected patients.


Continued . . .

LINK:

http://www.earthtimes.org/articles/show/virxsys-announces-at-croi-promising-results-from-its-hiv-vaccine-study,1171120.shtml

Penn researchers present Phase II HIV gene therapy trial data at CROI 2010

LINK:

http://www.eurekalert.org/pub_releases/2010-02/uops-prp021710.php

This article clearly explains the difference between VRX496 and VRX1023, both from VIRxSYS:

U.S. company Virxsys says using AIDS to fight AIDS

LINK:

http://www.reuters.com/article/idUSTRE61I00820100219
 

[John2038]

VIRxSYS seems promising accordingly to the presentation they have made at the CROI 2010.

You will find many articles on the net about what has been said.
Among others:

"We said 'let's use HIV against itself', and that's what we're doing", New Scientist quoted Gary McGarrity, VIRxSYS's vice president of scientific and clinical affairs, as saying.

Describing how they vaccinated monkeys, and then six months later injected them with SIV, VIRxSYS researchers said, “Within weeks of receiving the injection of SIV, concentrations of the virus had fallen by at least 95 per cent in those treated. After a year, when the trial ended, these concentrations remained low, whereas untreated monkeys became progressively sicker as their immune systems were depleted by the virus”.

You may want to read that also:

“The results from this trial are very impressive and I believe could provide real excitement in the world of HIV vaccines.”

Something is happening I guess ...

[Hellraiser]

The next step is taking hiv- people, giving them the vaccine and then exposiing them to the virus?

[Inchlingblue]

Keep in mind they reported on findings of two different products, VRX496 and VRX1023. Both were promising but they are each very different from each other. Explained in the link in my previous post.

[John2038]

Hellraiser

About the VRX1023, the company is planning to apply for approval to perform human trials.

VIRxSYS says such trials would initially be only in people who already carry the virus, rather than in healthy people at risk of infection. This will certainly make for a less controversial trial, as it would avoid any chance of the vaccine going "live" and infecting people who didn't have HIV to start with.

http://www.newscientist.com/article/dn18551-fight-hiv-with-hiv-safe-virus-proposed-as-vaccine.html

About the VRX496, human trials have already been made and are still on-going.

[tommy246]

Thats very intresting and good news john sounds like there happy with the results with the monkeys when will the human trialls be complete any ideas ?
Also how often would these vaccines be taken .

[sensual1973]

.

[hahaha]

Does Virxsys give out any charts, numbers, diagram in CROI 2010 for reference purpose?
Am curious about how "good" they are after injection, and how long it last.

[Inchlingblue]

VIRxSYS Presents Results From Multiple Studies At The 13th ASGCT Annual Meeting

LINK:

http://www.medicalnewstoday.com/articles/189685.php

[BlackLion]

"In accordance with FDA guidelines, all subjects will continue to be monitored for safety for up to 15 years"

Anyone can explain that? we must wait 15 years in case that VRX496 succeed in treating infeted people?

[Hellraiser]

"In accordance with FDA guidelines, all subjects will continue to be monitored for safety for up to 15 years"

Anyone can explain that? we must wait 15 years in case that VRX496 succeed in treating infeted people?

Pretty sure that means after they've been released for public consumption they will be monitored for 15 years.  I could be wrong about that.

[BlackLion]

Thanks, I hope that I can use them soon so that I would be monitored for 15 years