March 18, 2024 News by Lindsey Shapiro, PhD Cell therapy using Tregs in MS headed to Phase 2 trials in Poland The Polish biotechnology company PolTREG plans to launch Phase 2 trials testing its Tregs therapy ā the T-cell-based treatment PTG-007 ā in people with multiple sclerosis (MS) in Poland later this year. The biotech company has earned a Current Good Manufacturing Practice (CGMP) certification for its new manufacturing…
January 5, 2024 News by Lindsey Shapiro, PhD FDA OKs Phase 2 clinical trial of KYV-101 for progressive MS The U.S. Food and Drug Administration (FDA) has cleared a Phase 2 clinical trial to test Kyverna Therapeutics‘ cell-based therapy candidate KYV-101 in people with treatment-resistant progressive multiple sclerosis (MS). Called KYSA-7 (NCT06138132), the open-label trial will enroll an estimated 12 patients with either primary progressive…
August 22, 2023 News by Patricia Inacio, PhD Progressive MS trial of vidofludimus calciumĀ fully enrolled A global Phase 2 clinical trial investigating theĀ oral therapy vidofludimus calcium (IMU-838) in people with progressive forms of multiple sclerosis (MS) has reached full enrollment, the treatment’s developer, Immunic Therapeutics, reports. Called CALLIPER (NCT05054140), the trial is assessing whether the neuroprotective effects of vidofludimus calciumĀ seen in…
April 26, 2023 News by Lindsey Shapiro, PhD AAN 2023: Tolebrutinib safely lowers relapse rates over 2.5 years About 2.5 years of treatment with tolebrutinib was associated with low relapse rates and stable disability levels among people with relapsing forms of multiple sclerosis (MS), according to data in an ongoing, open-label extension of a Phase 2b trial. The oral treatment also continued to show a “favorable”…
February 21, 2023 News by Margarida Maia, PhD Phase 2 trial to determine if low-dose ketamine eases MS fatigue A Phase 2 clinical trial evaluatingĀ whether a low dose of ketamine can ease fatigue in people with multiple sclerosis (MS) is enrolling patients at Johns Hopkins University in Baltimore. The study, called INKLING-MS (NCT05378100), is recruiting up to 110 patients, ages 18-65,Ā who have been complaining of fatigue as…
January 26, 2023 News by Patricia Inacio, PhD Patient Dosing Starts in MS Phase 2 Clinical Trial of Oral SAR443820 Patient dosing has begun in a Phase 2 trial testing Denali Therapeutics‘ investigational oral RIPK1 inhibitor SAR443820 in people with multiple sclerosis (MS). The clinical trial (NCT05630547) seeks to enroll about 168 patients, age 18ā60, with either relapsing-remitting MS (RRMS), active and nonactive secondary progressive…
December 14, 2022 News by Joana Vindeirinho, PhD Tecfidera Has No Impact on PPMS Progression After 2 Years: Trial Data Continuous treatment with Tecfidera (dimethyl fumarate) for more than two years did not slow clinical and radiological measures of disease progression in people with primary progressive multiple sclerosis (PPMS) compared with patients who started treatment after one year. In fact, most PPMS patients remained stable with or without…
September 16, 2022 News by Marisa Wexler, MS NurOwn Found Safe, Shows Promise in Phase 2 Trial for Progressive MS NurOwn, a stem cell therapy being developed by BrainStorm Cell Therapeutics, showed a good safety profile among people with progressive forms of multiple sclerosis (MS) in an open-label Phase 2 clinical trial, according to new data. The data show the experimental therapy also was associated with promising effects on…
February 15, 2022 News by Steve Bryson, PhD VISIONARY-MS Trial of CNM-Au8 to End Early Due to Pandemic VISIONARY-MS, a Phase 2 clinical trial evaluating the safety and effectiveness of CNM-Au8 in people with relapsing multiple sclerosis (MS) with disease-related visual impairment, will conclude early due to COVID-19 pandemic-related challenges. The release of trial data is expected in the second half of this year, according to…
March 18, 2019 News by Jonathan Grinstein Progressive MS Phase 2 Trial of NurOwn Stem Cell Therapy Enrolls 1st Patient The first patient has been enrolled in a Phase 2 multicenter clinical trial testing the use of NurOwn cellular therapy to treat progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics announced. The open-label trialĀ (NCT03799718), titled Safety and Efficacy of Repeated Administration ofĀ neuronĀ (MSC-NTF Cells) nin Participants…
June 20, 2016 News by Patricia Silva, PhD Phase 2 Study to Evaluate an Oral Drug to Treat MS-related Spasticity and Cramps Flex Pharma, Inc., announced the start of aĀ Phase 2Ā clinical trialĀ assessing the safety and efficacy ofĀ FLX-787 in multiple sclerosis (MS) patients who suffer fromĀ cramps, spasms, and/or spasticity as a result of the disease. The trialĀ is being run in conjunction withĀ Neuroscience Trials Australia. Flex Pharmaās FLX-787 is aĀ single molecule,…
January 20, 2016 News by Patricia Silva, PhD Potential MS Stem Cell Therapy Moves into Phase 2 Trial for 1st Time in US The Tisch MS Research Center of New York (Tisch MSRCNY) recently announced that its stem cell-based therapy as a potential treatment for multiple sclerosis (MS) will move into Phase 2 clinical testingĀ after encouraging results in a Phase 1 trial, and on the advice of Ā the U.S. Food and Drug…