MSRV Retrovirus, phase 2

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MSRV Retrovirus, phase 2

Postby Fred1208 » Thu Dec 20, 2012 4:05 pm

Hello everybody :smile:

I am involved in the following study, described hereafter.

Mister Hervé Perron, who found the retrovirus, gave more details here : http://www.forseps.org/t1921-reponses-sur-le-retrovirus (in French), and you can follow my experience regarding this test here : http://www.forseps.org/t1920-fred1208-geneve (in French).

Source http://www.bioworld.com :

Spun out in 2006 from French diagnostics firm BioMérieux SA with the help of Swiss bioincubator
Eclosion, GeNeuro SA has slowly but steadily progressed its monoclonal antibody (mAb) technology – initially to prevent the inflammatory and autoimmune cascades induced by the multiple sclerosis-associated retrovirus (MSRV).

The Geneva-based biotech is now hitting its stride. Following a Phase I study of lead candidate GNbAC1 in 33 healthy volunteers last year, in September GeNeuro launched a randomized, placebo-controlled Phase IIa study at two sites in Switzerland to test single-ascending doses of the compound in MS patients. The study is primarily examining safety and pharmacokinetics, and a six-month repeated-dose extension is planned.
Anticipating positive findings, GeNeuro is planning a Phase IIb trial that will enroll MS patients at approximately 20 centers across Europe, according to François Curtin, the company’s CEO. GeNeuro plans to launch the study by next year.
MSRV initially was isolated in the 1990s in cell cultures from patients affected with MS. Normally latent in an individual’s genome, the human endogenous retrovirus (HERV) is thought to play a critical role in the pathogenesis of MS, expressing a pathogenic envelope protein known as MSRV-Env. GNbAC1, GeNeuro’s humanized IgG4 mAb, targets that envelope protein, which is thought to induce inflammatory cytokines and toxicity on oligodendrocytes by engaging the CD14 and TLR4 receptors.
“This protein is highly expressed in lesions of MS, especially active lesions,” prompting an inflammatory
response, Curtin told BioWorld Today. Data collected by the company since its inception suggest 75 percent of MS patients express MSRV-Env, “which represents a very exciting target for treatment,” he said.

The company’s mAbs have demonstrated efficacy, both in vitro and in vivo, with no evidence of adverse effects. GeNeuro’s intravenous formulation is designed for monthly infusion, similar to that of Tysabri (natalizumab, Biogen Idec Inc./Elan Corp. plc), according to Curtin.
Although drugs currently used to treat MS are designed to slow the neurological damage and disability caused by the disease, GeNeuro’s approach is directed upstream of the inflammatory demyelinating cascade, at the origin of the brain lesions, Curtin explained.
As befits a biotech with roots in diagnostics, GeNeuro also is developing diagnostic tests to dose the MSRV-Env protein in patients and to detect the antigen’s presence in blood. Studies in Europe conducted on the detection and dosage of the MSRV antigenemia in the serum of MS and schizophrenia patients showed a close association between the MSRV-Env protein and RNA of the MSRV retrovirus and
the two diseases, according to Curtin.
In fact, the very movement from discovering MSRV to considering a therapeutic approach against the
retrovirus led to the creation of GeNeuro. Hervé Perron, the company’s chief scientific officer, discovered viral-like particles (VLP) in the brain tissues of MS patients while he was a doctoral candidate looking for the viral code for MS. Perron subsequently joined BioMérieux, where he served as director of R&D for in vitro diagnostics in neurological disease, enabling him to continue investigating the VLPs in MS, which eventually were characterized as MSRV.

The retrovirus appears to trigger and aggravate environmental co-factors in the development and
progression of not only MS but also schizophrenia – a second indication that excites the company. With academic collaborators in France, GeNeuro demonstrated that about 40 percent of patients with schizophrenia express a high level of biomarkers associated with the retrovirus.
Those patients also exhibit an inflammatory syndrome that includes increases in C-reactive protein – a surprise to GeNeuro when the finding was discovered about three years ago, Curtin said. Independent researchers in China subsequently reported in a study that a group of some three dozen patients with schizophrenia in China exhibited increased levels of the HERV-W virus family associated with
MSRV.
“That was very good validation for our concept,” Curtin said, indicating the company plans to pursue the indication as resources allow. “We think we have a very interesting new approach to schizophrenia and, potentially, other psychiatric disorders,” he said. “For the treatment of these patients, we are still
relying on antipsychotics developed 50 years ago.” With 14 employees and limited capital, however, “we
have to focus on priorities,” Curtin admitted. “Now that we’re in clinical development, we have a lot of resources going into our main indication in MS.”
GeNeuro continues to enjoy the support of BioMérieux and its parent holding company Institut Mérieux, as well as Eclosion. To date, the company has raised about $20 million, with the next financing round scheduled for early 2013. That funding should see GeNeuro through the Phase IIa study.
The company expects to partner with a large pharma when GNbAC1 is ready to move into Phase III, and those talks have already begun.
“Our investors are ready to help us to move ahead to Phase II until we have a nice proposal” to present to potential partners, Curtin said.
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Fri Dec 21, 2012 7:17 am

For information, I received today the confirmation that the six-month repeated-dose extension has just been agreed.
It means that those who have been involved in IIa phase, will start this extension in January 2013, and will receive the first monthly dose.

Please note you have the possibility to translate each French topic (Links given in previous post), by clicking on the link at the right bottom “traduire” (translate).

Merry Christmas ! :smile:
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Sun Feb 10, 2013 11:32 am

American Academy of Neurology - San Diego - 16th to 23rd March

The first results of the Phase IIa study in MS patients with GeNeuro GNbAC1 monoclonal antibody will be presented at the 65th AAN annual meeting.

www.aan.com
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Re: MSRV Retrovirus, phase 2

Postby CureOrBust » Mon Feb 11, 2013 4:44 am

If this retro virus thingy is so prevalent in MS, and is also related to schizophrenia, would we not also be in a higher risk group fro Schizophrenia? are we statistically?
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Sun Feb 24, 2013 4:10 am

Good question, but I don't have any data regarding this point.

Schizophrenia is still in preclinical phase.
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Re: MSRV Retrovirus, phase 2

Postby Redo » Fri Mar 22, 2013 2:51 pm

Fred1208 wrote:Hello everybody :smile:

I am involved in the following study, described hereafter.


Intriguing. Gotta say I am a bit envious. Have you got your first infusion yet?
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Re: MSRV Retrovirus, phase 2

Postby lena-g » Sun Mar 24, 2013 5:59 am

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Re: MSRV Retrovirus, phase 2

Postby Redo » Sun Mar 24, 2013 3:11 pm

Hello Lena,

Thanks for the links! I speak a couple of languages, but French isn't one of them. Would you mind giving me a quick summary of what's happening?
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Re: MSRV Retrovirus, phase 2

Postby NHE » Sun Mar 24, 2013 5:34 pm

Redo wrote:Hello Lena,

Thanks for the links! I speak a couple of languages, but French isn't one of them. Would you mind giving me a quick summary of what's happening?


Try plugging the url into Google's translator.

http://translate.google.com/
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Re: MSRV Retrovirus, phase 2

Postby Redo » Sun Mar 24, 2013 5:39 pm

Yeah, I know about that. The fairly long text makes somewhat sense when I browse throught it with GT, but if someone speaks French and could make a short summary of what's being written there, then that'd be great.
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Re: MSRV Retrovirus, phase 2

Postby Redo » Thu Apr 04, 2013 2:25 pm

Does anyone have inside info about what's being presented at the conferences where GeNeuro attends?

http://www.geneuro.com/en/news.php

Seems like they've been doing quite some of them lately.
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Sun Apr 07, 2013 5:38 am

Hello,

As I indicated, all patients (10) now received one single dose, 2mg or 6 mg/kg.
No side effects for anyone.
The target of this phase 2a was to check the security aspect.

Now, the six-month repeated-dose extension started.
Again, no side effects for anyone.

I personnally received 3 times 2mg/kg.
No improvement.
The dose could be not enough.

Some people saw improvements.
Regarding one guy, it seems they also noticed modification on his MRI.

Normally in a next future, all patients will receive 6mg/kg.

On www.forseps.org, you can translate each topic by clicking on the link at the right bottom “traduire” (translate).

Have a good day,

Fred
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Re: MSRV Retrovirus, phase 2

Postby Redo » Sun Apr 07, 2013 4:20 pm

Thanks for the update, Fred! If he seems to have gotten an modification on a MRI-scan, I gotta say that's promising. Yes, perhaps a higher dose would do the trick. I am rooting for you.
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Wed Apr 10, 2013 6:29 am

Hello,

Regarding the current clinical test, the complete results will be given in June.
During the AAN congress, only preliminary information has been given regarding the good tolerability of the product.

In June, the complete results will include pharmacokinetic data.

The decision of extension of this clinical test has been taken until the end of 2013 for the 10 people who were included in 2a phase.
These infusions will be dosed at 6 mg per kilo.

Following that, stronger doses could be planned in relation with the disease profile.

The starting of the phase 2b should be announced this autumn.
Geneuro, the laboratory in charge of these tests is currently in discussion to find a partner.
Some preclinical test should be done for other diseases, as some inflammatory psychosis (50% of cases) and diabetes (25% of cases).

This phase could be a phase 2b/3 thanks to fast track procedures.

Have a good day,

Fred
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Re: MSRV Retrovirus, phase 2

Postby Redo » Wed Apr 10, 2013 7:04 am

I'm glad to hear that. Have a good day, you too.
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