MSRV Retrovirus, phase 2

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Re: MSRV Retrovirus, phase 2

Postby Redo » Tue May 14, 2013 5:44 am

Seems like the purpose of this early pilot study is primarily to evaluate the safety of the doses. I'm glad to read that, really, since that could imply that a higher dose might have a better effect... I really think Perron et al. are on to something with regards to ERVs.
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Re: MSRV Retrovirus, phase 2

Postby Gogo » Thu Jun 13, 2013 10:52 am

Fred1208 wrote:“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.
...
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.


Frank, thank you for sharing the info with us. I am rooting for you.
Are you RRMS or progressive? Do you have active lesions?
I inferred it from the article that this drug might benefit people who have active lesions and who hav inflammation. In the progressive stage, many patients do not have active lesions and inflammation is not significant. Can they also benefit? Have you heard anything about it, who might benefit?
Thx
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Re: MSRV Retrovirus, phase 2

Postby Redo » Tue Jun 25, 2013 5:36 pm

I think that many of the medical autoimmune mysteries in our age share at least one common denominator. What I mean by that is pretty simple really; when we first discovered bacteria, loads of diseases with unknown ethology became both understood and treatable. When we discovered viruses, we were able to diagnose and treat loads of conditions. And I think that endogenous retroviruses will end up playing just that role with many autoimmune diseases with still an unknown ethology.

Here's a fascinating meta-study I came across on mainly endogenous retroviruses and autoimmunity, but also has some on methylation and epigenetics. http://www.ncbi.nlm.nih.gov/pmc/article ... 36489/#R24
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Wed Nov 06, 2013 8:22 am

Some news, phase 2b in 2014 in some places in Europe.

Please read the information given 2 days ago.
I stopped myself this study, due to the very low dose (2mg/kg) I received with no effect and because swiitzerland is far away from my home.

GeNeuro Successfully Completes Phase 2a Clinical Study with Novel Approach to Treat Multiple Sclerosis

First in Class GNbAC1 mAb Targets Human Endogenous RetroVirus

Geneva, Switzerland and Lyon / Archamps, France - November 4, 2013 – GeNeuro announced today that its GNbAC1 humanized monoclonal antibody was found to have a very good safety profile when administered to patients with relapsing and progressive forms of Multiple Sclerosis as part of a Phase 2a study. GNbAC1 is a first-in-class monoclonal antibody targeting a toxic protein of endogenous retroviral origin that has been identified as a potential key factor in the onset and development of multiple sclerosis. Enrollment of patients into a multinational Phase 2b study is expected to begin during the first half 2014.

“The safety data achieved in this Phase IIa study is excellent and supports the future development of GNbaC1 in both relapsing remitting and progressive MS,” commented François Curtin, CEO of GeNeuro. “While presenting at the recent ECTRIMS [1] congress in Copenhagen last month, GeNeuro’s approach was highlighted as one of the most innovative and promising new treatments in clinical development against MS as it specifically targets a potential causal factor of the disease.”

In the completed Phase 2a clinical study including a six-month extension, conducted to establish safety and pharmacokinetics, GNbAC1 demonstrated very good safety following repeated administration at 2 mg/kg and 6 mg/kg. The repeated administrations did not affect the immune system, the TLR4 function was preserved and no signs of induction of immunogenicity were observed.

About the ENV toxic Protein and its role in Multiple Sclerosis and other pathologies

The sequencing of the human genome revealed human endogenous retroviruses (HERV) represent more than 8% of the human genome and result from the integration of exogenous retroviruses DNA during the primate evolution.
The Multiple Sclerosis associated retrovirus (MSRV) is a member of the HERV-W family and was initially isolated in cell cultures from patients affected with Multiple Sclerosis in the 90’s. MSRV is normally latent in the genome of individuals, but it can be re-activated by certain co-factors to expresses a pathogenic protein, MSRV-Env. Recent evidence has demonstrated that this ENV-protein is expressed in MS lesions from an early stage, is pro-inflammatory and inhibits remyelination.

About GeNeuro

GeNeuro is a Swiss-based company created by Eclosion in 2006 as a spin-off of bioMérieux and co-funded by Eclosion and the Institut Mérieux. GeNeuro is developing first-in-class therapies against diseases associated with human endogenous retroviruses expression. Its lead product GNbAC1 targets MSRV-ENV protein closely linked to the onset and development of Multiple Sclerosis. Endogenous retroviral proteins are also associated with other diseases, including Type 1 diabetes, schizophrenia and chronic inflammatory demyelinating polyneuropathy (CIDP).
Further information can be found at: www.geneuro.com.

Contacts:
François Curtin, CEO Mike Sinclair
GeNeuro Halsin Partners
Tel: +41 (0)22 794 50 85 Tel: +44 (0)20 7318 2955
Email: fc@geneuro.com Email: msinclair@halsin.com
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Re: MSRV Retrovirus, phase 2

Postby Redo » Wed Dec 11, 2013 6:54 pm

It seems like GENeuro has got a lot of faith in this therapy, since they are now launching a new study with the same drug against schizophrenia http://www.geneuro.com/layout/modules/n ... titute.pdf
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Sat Dec 28, 2013 12:29 pm

Hi Gogo,

Sorry I didn't see your post.

I am in progressive stage.

Regarding this first clinical trial with only 10 people, all were in progressive stage.
As I said, some of them felt some improvements even if it was not the target of this trial, done to test the safety. It is too early to get some conclusions from that anyway. More people will be involved in the 2b phase, which should start in the first 6 months of 2014.

For sure this product would not be a miracle, and could not repair the damage done, but if at least it could allow to protect our brain, this one could maybe have the capability to manage some lesions itself.
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Re: MSRV Retrovirus, phase 2

Postby gibbledygook » Tue Jan 14, 2014 8:32 am

This study explains the female bias, at least as far as the retrovirus is concerned:

Retrovirology. 2014 Jan 9;11(1):2. doi: 10.1186/1742-4690-11-2.
HERV-W polymorphism in chromosome X is associated with multiple sclerosis risk and with differential expression of MSRV.
García-Montojo M, de la Hera B, Varadé J, de la Encarnación A, Camacho I, Domínguez-Mozo M, Arias-Leal A, García-Martínez A, Casanova I, Izquierdo G, Lucas M, Fedetz M, Alcina A, Arroyo R, Matesanz F, Urcelay E, Alvarez-Lafuente R.
Author information
Abstract
BACKGROUND:
Multiple Sclerosis (MS) is an autoimmune demyelinating disease that occurs more frequently in women than in men. Multiple Sclerosis Associated Retrovirus (MSRV) is a member of HERV-W, a multicopy human endogenous retroviral family repeatedly implicated in MS pathogenesis. MSRV envelope protein is elevated in the serum of MS patients and induces inflammation and demyelination but, in spite of this pathogenic potential, its exact genomic origin and mechanism of generation are unknown. A possible link between the HERV-W copy on chromosome Xq22.3, that contains an almost complete open reading frame, and the gender differential prevalence in MS has been suggested.
RESULTS:
MSRV transcription levels were higher in MS patients than in controls (U-Mann-Whitney; p = 0.004). Also, they were associated with the clinical forms (Spearman; p = 0.0003) and with the Multiple Sclerosis Severity Score (MSSS) (Spearman; p = 0.016). By mapping a 3 kb region in Xq22.3, including the HERV-W locus, we identified three polymorphisms: rs6622139 (T/C), rs6622140 (G/A) and rs1290413 (G/A). After genotyping 3127 individuals (1669 patients and 1458 controls) from two different Spanish cohorts, we found that in women rs6622139 T/C was associated with MS susceptibility: [χ2; p = 0.004; OR (95% CI) = 0.50 (0.31-0.81)] and severity, since CC women presented lower MSSS scores than CT (U-Mann-Whitney; p = 0.039) or TT patients (U-Mann-Whitney; p = 0.031). Concordantly with the susceptibility conferred in women, rs6622139*T was associated with higher MSRV expression (U-Mann-Whitney; p = 0.003).
CONCLUSIONS:
Our present work supports the hypothesis of a direct involvement of HERV-W/MSRV in MS pathogenesis, identifying a genetic marker on chromosome X that could be one of the causes underlying the gender differences in MS.
PMID: 24405691 [PubMed - in process] Free full text
http://www.ncbi.nlm.nih.gov/pubmed/24405691
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Re: MSRV Retrovirus, phase 2

Postby 1eye » Sat Jan 25, 2014 10:25 am

Abstract
BACKGROUND:

Human endogenous retrovirus (HERV) genes represent about 8% of the human genome. A member of the HERV family W, the Multiple Sclerosis-Associated Retrovirus (MSRV) gene, encodes an envelope protein (Env), which can activate a proinflammatory and autoimmune cascade through its interaction with Toll-like receptor 4. Due to its proinflammatory property and an inhibitory effect on oligodendrocyte precursor cell differentiation, the MSRV-Env protein could play a crucial role in the pathogeny of multiple sclerosis. GNbAC1 is a humanized monoclonal antibody of the immunoglobulin G4 type, which is directed against MSRV-Env. After validation of the MSRV-Env as a therapeutic target in preclinical experimental models, a clinical development program was initiated.
OBJECTIVE:

This study evaluated the safety profile, pharmacokinetic parameters, and immunogenicity of GNbAC1 in healthy male volunteers.
METHODS:

In this first-in-humans, Phase I, randomized, double-blind, placebo-controlled, dose-escalation study, each subject received a single dose of IV GNbAC1 0.0025, 0.025, 0.15, 0.6, 2, or 6 mg/kg or inactive vehicle (placebo), infused over 1 hour. Tolerability and other laboratory parameters were observed, and regular blood sampling was performed, to study the pharmacokinetic properties and immunogenicity of this monoclonal antibody.
RESULTS:

A total of 33 male subjects (mean age, 44 years) completed the study. GNbAC1 was well tolerated after dosing in all subjects and in each dose cohort. Only minor and nonspecific adverse events (AEs) were recorded; no serious AEs were reported. Pharmacokinetic data show a dose-linear pharmacokinetic profile. The mean elimination half-life ranged between 19 and 26 days, with therapeutically efficient concentrations maintained over a 4-week periods at doses of 2 and 6 mg/kg. No emergence of anti-GNbAC1 antibodies were detected after dosing in any subject over the entire observation period of 64 days.
CONCLUSIONS:

In these healthy male subjects, the safety and pharmacokinetic profiles of GNbAC1 appeared favorable. These findings are expected to allow for the launch of a Phase II development program for this innovative therapeutic approach in patients with multiple sclerosis. ClinicalTrials.gov identifier: NCT01699555.


Might want to check this newsletter out also: http://goo.gl/QfcrnL
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Re: MSRV Retrovirus, phase 2

Postby CureOrBust » Sat Jan 25, 2014 7:23 pm

I there a reason there are no actual statements regarding the patients MS responses to the treatment?
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Re: MSRV Retrovirus, phase 2

Postby gibbledygook » Mon Jul 07, 2014 2:10 am

More genetic evidence of an involvement in the retroviral area:

PLoS One. 2014 Jul 1;9(7):e101436. doi: 10.1371/journal.pone.0101436. eCollection 2014.
In Silico Analysis of Functional Single Nucleotide Polymorphisms in the Human TRIM22 Gene.
Kelly JN, Barr SD.
Author information
Abstract
Tripartite motif protein 22 (TRIM22) is an evolutionarily ancient protein that plays an integral role in the host innate immune response to viruses. The antiviral TRIM22 protein has been shown to inhibit the replication of a number of viruses, including HIV-1, hepatitis B, and influenza A. TRIM22 expression has also been associated with multiple sclerosis, cancer, and autoimmune disease. In this study, multiple in silico computational methods were used to identify non-synonymous or amino acid-changing SNPs (nsSNP) that are deleterious to TRIM22 structure and/or function. A sequence homology-based approach was adopted for screening nsSNPs in TRIM22, including six different in silico prediction algorithms and evolutionary conservation data from the ConSurf web server. In total, 14 high-risk nsSNPs were identified in TRIM22, most of which are located in a protein interaction module called the B30.2 domain. Additionally, 9 of the top high-risk nsSNPs altered the putative structure of TRIM22's B30.2 domain, particularly in the surface-exposed v2 and v3 regions. These same regions are critical for retroviral restriction by the closely-related TRIM5α protein. A number of putative structural and functional residues, including several sites that undergo post-translational modification, were also identified in TRIM22. This study is the first extensive in silico analysis of the highly polymorphic TRIM22 gene and will be a valuable resource for future targeted mechanistic and population-based studies.

http://www.ncbi.nlm.nih.gov/pubmed/24983760
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Mon Aug 04, 2014 1:25 am

Hello everybody.

As I explained, Geneuro in Swiss developped the humanized monoclonal antibody, and drove Phase 1 and phase 2a regarding clinical test (10 persons in phase 2a).

Geneuro already received some proposals regard in partnership and contacts with big pharmas, especially in US, to continue the tests, because a lot of money is needed.

The final decision of partnership was postponed many times, but we should know something very soon, probably in September.

It means that the 2b phase should be started, in a lot of medical centers. This time, the effictiveness should be studied. They already noticed some improvements on some of the first 10 patients.

Stay tuned :-)

Have a good day,

Fred
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Wed Sep 10, 2014 8:12 am

Hello,

Here is the last communication from Geneuro :



September 5, 2014

Novel MS Therapy from GeNeuro Performed
Well in Phase 2a Clinical Trial
A novel therapeutic from GeNeuro to treatmultiple sclerosis showed promising results in a one-year, open-label extension phase 2a clinical trial. GeNeuro tested its first-in-class GNbAC1monoclonal antibody in ten multiple sclerosis patients, nine of whom have primary or secondary progressive multiple sclerosis.

“We are very excited by the potential that GNbAC1 offers as a new avenue to treat multiple sclerosis patients,” said Francois Curtin, CEO of GeNeuro, in a press release from the company. “In addition to confirmation of long-term safety of the monoclonal antibody in patients, we have seen that the cohort of progressive multiple sclerosis patients was stable over one year from both clinical and MRI standpoints.”

The trial, “Safety Study of GNbAC1 in Multiple Sclerosis Patients” was designed to compare GNbAC1 to a placebo for 177 days in single ascending doses and repeated administration. Although safety was the main outcome, the trial also evaluated drug distribution in the body, as well as effects of GNbAC1 on patients through MRI and serum analysis of MSRV-Env, a protein considered to be a major trigger for and activator of multiple sclerosis disease progression.

Patients showed excellent tolerability for repeated administration of GNbAC1, verifying the outcome of aphase 1 study that was a first-in-human trial. Moreover, the average Expanded Disability Status Score (EDSS) to measure disease progression was stable for patients over one year. Bolstering support for a future Phase 2 trial, patients showed stable brain images and reduced levels of MSRV-Env biomarkers. “This reinforces our conviction that GNbAC1 can completely transform the multiple sclerosis therapeutic landscape,” said Curtin.

The concept of GNbAC1 is unique and challenges the status quo of traditional multiple sclerosis therapies. According to Curtin, “Preliminary results of this study presented at the American Academy of Neurology earlier this year generated a high level of enthusiasm among clinicians as they see this treatment could bring new hope to patients as a safe therapy addressing a causal factor of the disease, breaking with the immunosuppressive logic of existing treatment.” To follow up these positive results, GeNeuro will begin a proof-of-concept clinical study in 2015.
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Thu Sep 11, 2014 4:39 am

For information, Geneuro Company is going to present the results there :

http://www.msboston2014.org/

Here are the posters :

http://www.abstractstosubmit.com/msbost ... d=243&t=f&
http://www.abstractstosubmit.com/msbost ... d=193&t=f&
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Re: MSRV Retrovirus, phase 2

Postby Fred1208 » Tue Dec 02, 2014 5:58 am

Phase 2b in progress :

PRESS RELEASE

GeNeuro and Servier sign partnership to develop first medicine addressing a causal factor of Multiple Sclerosis
• GeNeuro responsible for development of GNbAC1 till completion of Phase IIb in Multiple Sclerosis, receiving $47M from Servier, after which Servier can exercise licensing option in all markets excluding the USA and Japan.
• GeNeuro retains independence & full control of the U.S. & Japan and for applications of its technology in other diseases.
• After exercising option, Servier will cover Phase III global development costs and pay GeNeuro up to US$408M in future development and sales milestones, as well as royalties on future sales.
• Servier will also have the option to take an equity stake in GeNeuro as a minority shareholder in 2015.

December 2, 2014, Geneva, Switzerland, and Suresnes, France - GeNeuro SA, a pioneer of new therapies for neurology and autoimmune disorders, announced today that it has entered into a strategic partnership with Servier, the leading independent French pharmaceutical company, to develop and market GNbAC1 in Multiple Sclerosis (MS). As the first drug addressing a causal factor of the disease, GNbAC1 has the potential to radically change the way MS patients are treated.
GNbAC1, a humanized monoclonal antibody, targets MSRV-Env, the envelope protein of MS associated retrovirus, a member of the HERV-W family, the expression of which is usually silent but reactivated and expressed in MS lesions from an early stage in the disease. This protein has been shown to be both pro-inflammatory and an inhibitor of remyelination, the two major drivers of MS pathophysiology.

By targeting MSRV-Env, GeNeuro expects to bring to patients a safe, effective treatment that can halt progression of both relapsing-remitting and progressive forms of the disease without hampering the patient’s immune system. GNbAC1 has successfully completed Phase IIa, demonstrating an optimal safety profile and encouraging signs of efficacy on a first small cohort of patients. “GNbAC1’s original mode of action proposes a true innovation in the field of MS” says Prof Hans-Peter Hartung, chairman of the Department of Neurology of the University Hospital Düsseldorf and chairman of GeNeuro’s Advisory Board.

Under the terms of the agreement, GeNeuro will be responsible for the development of GNbAC1 until completion of Phase IIb, after which Servier can exercise the option to license the product for all markets excluding the USA and Japan. Financial considerations include the payment by Servier to GeNeuro of US$47 million to finance the completion of Phase IIb. Subsequent to exercising the option agreement, Servier will cover the costs of the Phase III global development program and pay GeNeuro up to US$408 million in future development and sales milestones, as well as royalties on future sales. Servier will also have the option to take an equity stake in GeNeuro as a minority shareholder in the next 12 months.

For François Curtin, CEO of GeNeuro stated: “This strategic agreement with Servier is a recognition of the innovative nature and huge potential of GeNeuro’s technology. Combining GeNeuro’s technical expertise with Servier’s scientific, medical and financial resources will create an exciting new alliance to fuel the development of our unique approach, ultimately benefitting MS patients around the world.”

Jesús Martin-Garcia, Chairman of GeNeuro declared: “This agreement is an ideal way to develop GeNeuro’s technology and deliver its full value for patients and stakeholders. With all further development costs in MS funded by our partner, GeNeuro has a clear path forward with a manageable geographic focus on two of the world’s major markets.”
Emmanuel Canet, VP Research & Development at Servier underlined that: “The importance of this agreement demonstrates Servier’s willingness to dedicate its research to serious diseases with major unmet medical needs. This new partnership should allow Servier to provide patients with a new treatment against a particularly disabling disease”.
Christian de Bodinat, Director of the Neuro-psychiatry Therapeutic Innovation Centre mentioned: “MS – and especially its progressive forms – is still today a major source of handicap in the world with no satisfactory therapeutic options. We are also confident that the strong expertise of GeNeuro in MS combined with Servier’s clinical experience in neurology will result in a perfect match for driving GNbAC1 to success.”

Olivier Laureau, President of Servier added: “Not only will this new strategic alliance allow Servier to enrich its portfolio in a disease with a huge unmet medical need, but we are especially proud to count as partner a company that was spun-off from Institut Mérieux, a French institution internationally recognized for its excellence in research.”

About Multiple Sclerosis
Multiple Sclerosis is an autoimmune disease affecting the brain and spinal cord, driven by inflammatory and neuro-degenerative processes. It damages the myelin sheath, the material that surrounds and protects nerve cells, resulting in axonal damage. This slows down or blocks nervous conduction between the brain and the body, which leads to the symptoms of MS. The causes of MS are still unclear.
This disease takes three main forms:
• Primary Progressive Multiple Sclerosis (PPMS, about 10% of patients at onset), where symptoms continually worsen from the time of diagnosis.
• Relapsing-Remitting Multiple Sclerosis (RRMS, about 90% of patients at onset), characterized by unpredictable attacks of neurological symptoms followed by partial or complete recovery.
• Secondary Progressive MS (SPMS), developed after several years of relapsing-remitting MS, in which symptoms worsen without relapses.
Present MS treatments address RRMS forms, targeting the patient’s immune system to lower the frequency of relapses, with not always a clear impact on overall disease progression, and at the cost of an increased risk of opportunistic infections and cancers. The situation is even less satisfactory in progressive forms of the disease (about 40% of patients), with a high medical need and no approved treatment for PPMS forms.

About Servier
Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular-, metabolic-neurologic-, psychiatric-, bone- and joint diseases as well as cancer.
In 2013, the company recorded a turnover of 4.2 billion euros.
91 percent of Servier drugs are consumed outside France.
27 percent of turnover from Servier drugs were reinvested in Research and Development in 2013.
With a strong international presence in 140 countries, Servier employs more than 21,000 people worldwide.
More information: MailScanner has detected a possible fraud attempt from "email.prnewswire.com" claiming to be www.servier.com

About GeNeuro and its technology
GeNeuro was created in 2006 at Eclosion, the Geneva life sciences accelerator, as a spin-off of Institut Mérieux where the technology was originally discovered. It develops first-in-class therapies against diseases associated with the expression of pathogenic proteins of human endogenous retroviral origin (HERV). Its lead product GNbAC1 targets MSRV-Env, a protein expressed in MS lesions from an early stage, which has been shown to be both pro-inflammatory and an inhibitor of remyelination, the two major drivers of MS progression.

The Multiple Sclerosis associated retrovirus (MSRV) is a member of the HERV-W family and was initially isolated in cell cultures from patients affected with Multiple Sclerosis. MSRV is normally latent in the genome of individuals, but it can be re-activated by viral infections and other co-factors to express a pathogenic protein, MSRV-Env. MSRV-Env provides the missing link between the observation that viral infections are associated with the onset of the disease and expression of the pathogenic factor (the MSRV-Env protein), which can then explain the inflammatory and demyelinating characteristics of MS.
By targeting MSRV-Env, GeNeuro expects to bring to patients a safe, long-term treatment that can halt progression of the disease, addressing both the inflammatory and demyelinating mechanisms relevant for all forms of MS. As the first drug addressing a causal factor of the disease, it will radically change the way MS patients are treated.
Further information can be found at: MailScanner has detected a possible fraud attempt from "email.prnewswire.com" claiming to be www.geneuro.com.
Contacts:

François Curtin, CEO Mike Sinclair
GeNeuro Halsin Partners
Tel: +41 (0)22 794 50 85 Tel: +44 (0)20 7318 2955
Email: fc@geneuro.com Email: msinclair@halsin.com

Direction de la Communication Institutionnelle
SERVIER
Tel: +33 (1) 55 72 60 37
Email: presse@servier.fr
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Re: MSRV Retrovirus, phase 2

Postby CureOrBust » Wed Dec 03, 2014 1:53 am

Fred1208 wrote: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.
anywhere where the results have been published? I could not find them

Also I noted that one of the excerpts said there was a placebo arm, and that you felt that you did not respond. Have you found out if you were possibly in the placebo arm?
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