March 23, 2022 News by Marta Figueiredo, PhD ProTEct-MS Trial Data Reinforce Previous Temelimab Studies Higher doses of temelimab were generally safe and resulted in beneficial trends on key neurodegeneration markers in adults with relapsing forms of multiple sclerosis (MS) who already were on rituximab treatment, according to top-line data from the ProTEct-MS Phase 2 clinical trial. While the studyās small size…
February 7, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: Predicting Disease Progression, Temelimab, Trigeminal Neuralgia Combined Data May Predict Personās Risk of Advancing From CIS to MS Clinically isolated syndrome is sometimes called “early MS.” It’s the diagnosis used when someone’s symptoms don’t quite look like MS, but it does appear that MS is lurking. It may take years for an actual…
January 31, 2022 News by Vanda Pinto, PhD Final Data Likely Soon in Phase 2 Trial of Temelimab for Relapsing MS A Phase 2 clinical trial into the safety and tolerability of higher-doseĀ temelimab as a potential therapy for relapsing forms of multiple sclerosis (MS) is now complete, and top-line data is expected by late March, its developer,Ā GeNeuro, announced. The ProTEct-MS Phase 2 trial (NCT04480307), conducted at the Karolinska…
September 27, 2021 News by Vanda Pinto, PhD 1st Patient Enters ProTEct-MS Extension Trial Testing Higher Temelimab Doses The first patient who completed theĀ ProTEct-MS Phase 2 clinical trial assessing temelimab as a treatment for relapsing forms of multiple sclerosis (MS) has entered the trial’s extension part. In the open-label extension trial, patients will switch to or continue to receive temelimab at least until next spring, when…
July 21, 2021 News by Forest Ray PhD Low Temelimab Doses in RRMS Trial Among Reasons for Poor Results Low doses selected and underlying inflammatory disease may have confounded the ability of temelimabĀ to significantly affect neuroinflammation in a Phase 2 trial in relapsing-remitting multiple sclerosis (RRMS) patients. GeNeuro‘s investigational MS therapy did, however, show other evidence of clinical benefit that supports its continued development, researchers…
March 15, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: Cure Connections, PIPE-307, Temelimab, EHP-101 NeurologyLive, CMSC Launch Expert Video Series āCure Connectionsā This series of 13 videos, designed for healthcare professionals, focuses on diagnosing MS, its psychological impact, managing symptoms, and treatments. Quality-of-life issues, fatigue, and patient support networks also will be discussed. I hope general neurologists will watch it, not just MS…
March 8, 2021 News by Teresa Carvalho, MS Safety Board Says Phase 2 Temelimab Trial Should Move Forward A Phase 2a clinical trial evaluating GeNeuro‘s investigational antibody temelimab as a treatment for relapsing multiple sclerosis (MS) should continue as planned, without modifications. That’s the recommendation of a Drug Safety Monitoring Board, an independent committee of clinical research experts, which was evaluating the trial of the…
February 24, 2021 News by Patricia Inacio, PhD Enrollment Complete in Phase 2 Trial Testing Temelimab GeNeuroĀ has completed patient enrollment in its ProTEct-MS Phase 2 clinical trial evaluating temelimab as a treatment for multiple sclerosis (MS), the company announced. The study (NCT04480307), taking place at the Karolinska Institutetās Academic Specialist Center (ASC) in Stockholm, Sweden, has enrolled 42 people with relapsing MS whose…
September 11, 2020 News by Joana Carvalho, PhD #MSVirtual2020 – GeNeuro’s Temelimab Found Safe When Given Alongside Rituximab Temelimab, GeNeuroās investigative treatment for multiple sclerosis (MS), showed a favorable safety profile when given alongside rituximab, according to preclinical safety experiments performed in preparation for the companyās new Phase 2 trial involving patients with relapsing MS. Data from the preclinical experiments, along with details of…
June 30, 2020 News by Forest Ray PhD Study of Temelimab in MS Progression Without Relapse Enrolls 1st Patient GeNeuro announced that a firstĀ multiple sclerosisĀ (MS)Ā patient has enrolled in its Phase 2 trial assessing the safety and effectiveness of temelimabĀ in people whose disease is progressing in the absence ofĀ relapses. This trial, taking place atĀ the Karolinska Institutetās Academic Specialist Center (ASC), in Stockholm,Ā had been postponedĀ to reduce…
March 23, 2020 News by David Melamed, PhD Phase 2 Trial of Progressive MS Treatment Postponed Due to COVID-19 A planned Phase 2 clinical trial of a potential treatment for progressive multiple sclerosisĀ has been postponed to keep hospital resources open to treat people with COVID-19 during the ongoing global outbreak, and to reduce the risk of exposure to MS patients, GeNeuro, the investigate therapy’s developer, announced. The…
November 27, 2019 News by Iqra Mumal, MSc MS Specialist to Lead Trial of Temelimab in Progressing Disease Without Relapses GeNeuro is collaborating with clinical researchers at theĀ Karolinska Institutet and the Academic Specialist Center (ASC) in Stockholm to open a new clinical trial of temelimab in people whoseĀ multiple sclerosis (MS) is progressing in the absence of relapses. Fredrik Piehl, MD, PhD, a professor of neurology at…
July 2, 2019 News by Jose Marques Lopes, PhD Protein Linked to Microglia Cell Activation and Nerve Fiber Damage in Study That Also Notes Potential Treatment A proteinĀ leads to nerve fiber and myelin damage, particularly in progressive forms of multiple sclerosis, by activating brain immune cells called microglia, according to a new study. Its researchers also noted this protein is theĀ target ofĀ experimental MS treatment calledĀ temelimabĀ (GNbAC1), which showed potential in Phase 2 clinical trials. The…
March 18, 2019 News by Jose Marques Lopes, PhD Temelimab Provides Long-term Benefits in RRMS Patients, Extension Study Shows Two-year treatment with temelimab reduced brain atrophy, or shrinkage, preserved myelin, and reduced disease progression in patients with relapsing-remitting multiple sclerosisĀ (RRMS), according to findings from an extension study of a Phase 2b clinical trial. Temelimab, previously known as GNbAC1, is a monoclonal antibody that neutralizes the MS-associated human…
February 4, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: MS Pain Research, Myelin Studies, Antibody Trial MS Patients Sought to Test Alternative Chronic Pain Treatment Methods Do you have serious pain issues along with your MS? If so, you might be interested in this study that’s looking for participants. By the way, who says that pain isn’t an MS symptom? A clinical trial…
January 25, 2019 News by Jonathan Grinstein Positive Safety Data Reported for High-dose MS Treatment Candidate Temelimab GeNeuroĀ has reported positive data from a Phase 1 clinical trial (NCT03574428) evaluating the safety and tolerability of high doses ofĀ GNbAC1, developed for the treatment of neurological and autoimmune disorders, includingĀ multiple sclerosis (MS). The company also announced that the World Health…
October 18, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – GNbAC1 Shows Consistent Neuroprotection in RRMS Patients, Phase 2b Study Reports TreatingĀ relapsing-remitting multiple sclerosis (RRMS) patients with GeNeuroās investigational compound GNbAC1 lessened brain atrophy and lesion load and suggested myelin preservation, according to results of a Phase 2b study. Importantly, monthly intravenous GNbAC1 administration for 48 weeks also had neuroprotective effects in the studyās inactive population, which refers…
September 19, 2018 News by Patricia Inacio, PhD GeNeuro to Develop the MS Clinical Program of GNbAC1 Without Servier GeNeuroĀ announced it has reacquired from Servier the worldwide rights to commercialize and develop the investigational humanized antibodyĀ GNbAC1Ā for the treatment of multiple sclerosis (MS). The decision came after Servier, a European company which, together with GeNeuro, developed the GNbAC1 program, declined to continue developing the therapy due to…
March 29, 2018 News by Patricia Inacio, PhD GeNeuro-Servier Antibody Limits RRMS Patients’ Brain Shrinkage, Phase 2b Trial Shows The laboratory-generated antibodyĀ GNbAC1Ā continued to limitĀ brain shrinkage a year after relapsing-remitting multiple sclerosis patients began receiving it, its developers announced. GeNeuro and ServierĀ were reporting on the 12-month results of aĀ Phase 2b clinical trial. GNbAC1 is a monoclonal antibody that destroys a harmful retroviral protein called pHERV-W which scientists have…
October 30, 2017 News by Patricia Inacio, PhD #MSParis2017 – GNbAC1 Promotes Restoration of Protective Myelin Coating, Phase 2b Trial Shows GeNeuro‘s humanized antibodyĀ GNbAC1Ā promotes the rejuvenation of the myelin coating that protects nerve cells in patients withĀ relapsing-remitting multiple sclerosis, or RRMS, a Phase 2 clinical trial shows. The treatment is also safe, the study showed. Dr. Hans-Peter Hartung of theĀ Heinrich-Heine-University DĆ¼sseldorfĀ in Germany presented the results at theĀ 7th…
August 30, 2017 News by Patricia Silva, PhD Retroviral RRMS Treatment GNbAC1 Fails Phase 2 Trial, But Research Continues, Say Sponsors A Phase 2b trial assessingĀ the experimental retroviral-targeting treatment GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS) failed to meet its primary goal of reducing brain lesions and other signs of brain inflammation within six months. But researchers at GeNeuro and ServierĀ ā the two European companies thatĀ jointly developed the drug…
January 5, 2017 News by Joana Fernandes, PhD CHANGE-MS Phase 2 Study Fully Enrolled Early, Results Due in Fall GeNeuro recently announced that it has finished enrolling multiple sclerosis (MS) patients in the CHANGE-MS Phase 2b Ā studyĀ ā several months ahead of schedule.Ā The company nowĀ expects to reportĀ topline results in mid- to late autumn rather than at year’s end. āCompleting enrollment in CHANGE-MS several months sooner than previously anticipated…
December 8, 2016 News by Joana Fernandes, PhD MS Patients in Clinical Trial of GNbAC1 May Continue with Therapy in Extension Study Multiple sclerosis (MS) patients now taking part in a Phase 2b clinical trial testingĀ the efficacy and safety of theĀ antibody GNbAC1Ā will be invited to continue withĀ treatment for two more years under a planned extension study, the biopharmaceutical companiesĀ GeNeuroĀ andĀ ServierĀ recently announced. Several MS therapies rely on the capacity of antibodies to…
September 20, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – GeNeuro Reaches Enrollment Halfway Mark in Study of GNbAC1 to Treat Multiple Sclerosis GeNeuroĀ announced that it has reached ā more quickly than expected ā the halfway mark for patient enrollment inĀ itsĀ Phase 2b study, CHANGE-MS,Ā assessingĀ GNbAC1 as a therapy forĀ relapsing-remitting multiple sclerosis (RRMS). Patient recruitmentĀ is continuing at sites across Europe. The company alsoĀ reported onĀ theĀ trial’s design in a poster presentation, “A placebo…
June 10, 2016 News by Patricia Inacio, PhD First MS Patients in CHANGE-MS Trial Receive Novel Treatment GeNeuro, a biopharmaceutical company that focusesĀ on novel treatments for autoimmune diseases such as multiple sclerosis (MS), announced thatĀ the first patients with relapsing-remitting multiple sclerosis (RRMS) are underĀ treatment with the companyās leading drug, GNbAC1, in aĀ Phase 2b clinical trial. GNbAC1 is a monoclonal antibody designed to neutralize MSRV-En, a protein…
December 22, 2015 News by Patricia Silva, PhD Experimental RRMS Therapy to Be Tested in a Phase 2b Clinical Trial GeNeuro, a company developing therapies for neurological and autoimmune disorders, recently announced the initiation of a Phase 2b clinical trial to assess its lead investigational antibody GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called āCHANGE-MS,ā plans to enroll 260 patients across 68 centers acrossĀ theĀ European Union and…
December 4, 2014 News by Patricia Silva, PhD GeNeuro and Servier to Co-Develop Breakthrough Multiple Sclerosis Drug Neurology and autoimmune therapeutics companyĀ GeNeuro SA has just announced the formation of a partnership with independent French pharmaceutical companyĀ ServierĀ for the co-development and marketing of GNbAC1 for Multiple Sclerosis (MS). It is the first humanized monocloncal antibody treatment formulated to address one of this disease’s causal factors, making it…
September 5, 2014 News by Maureen Newman Novel MS Therapy from GeNeuro Performed Well in Phase 2a Clinical Trial A novel therapeutic from GeNeuro to treat multiple sclerosis showed promising results in a one-year, open-label extension phase 2a clinical trial. GeNeuro tested its first-in-class GNbAC1 monoclonal antibody in ten multiple sclerosis patients, nine of whom have primary or secondary progressive multiple sclerosis. “We are very excited by the…