ublituximab

#MSParis2017 – TG Therapeuticsā€™ Ublituximab Depletes Harmful B-cells and Lowers MRI Lesions, Trial Shows

TG Therapeuticsā€™Ā ublituximab nearly eradicated a type of immune B-cell believed to be involved in multiple sclerosis,Ā according to a Phase 2 clinical trial. The result was that none of the patients had a relapse during the first six months of the trial, which is continuing, researchers said. In addition,Ā ublituximabĀ reduced the brain and spinal cord lesions of the relapsing MS patients involved in the trial and prevented new ones from forming. The company will present the interim trial results in threeĀ poster presentations at theĀ 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28. Meanwhile, researchers will continue to study the effectiveness of ublituximab, a B-cell-depleting antibody, versus a placebo, for another six months. The trial is being held at several U.S. medical facilities. Participants receive two initial infusions of ublituximab or a placebo on day 1 and 15 during the first 28 days. After this initial period, those in the placebo-group are also given ublituximab and followed for 52 weeks. A key trial finding was thatĀ over the initial 24 weeks of the trial, the treatment nearly wiped out a type of B-cell known as CD20 that scientists believe is involved in the development of MS. Only 1 percent of the B-cells remained after a month. While helpful immune T-cell numbers dropped slightly after the first ublituximab infusion, they bounced back quickly. Researchers also reported a reduction in patients' magnetic resonance imaging (MRI) lesions, with no new inflammatory lesions appearing during the six months. So far, none of the trial participants has had a serious adverse event. Most of the adverse events were mild or moderate and related to the infusions. The trial also demonstrated that speeding up infusions did not increase infusion-related reactions.Ā The speed-up results indicated thatĀ ā€” if proven effective and safe ā€” ublituximab will be more convenient for patients than B-cell-depleting drugs that require infusions stretching over several hours.

#MSParis2017 – TG Therapeutics to Discuss Ublituximab’s Effectiveness at ECTRIMSā€“ACTRIMS Meeting in Paris

TG Therapeutics will discuss ublituximab's ability to deplete B-cells linked to multiple sclerosis and to reduce inflammatory brain lesions at the 7th Joint ECTRIMSā€“ACTRIMS Meeting in Paris next month. The three presentations will cover preliminary results of a Phase 2 clinical trial of ublituximab's safety and effectiveness as a treatment for relapsing forms of MS, the company said in a press release. The conference will be Oct. 25-28. Dr. Amy E. Lovett-Racke of Ohio State University will discuss ublituximab's ability to decrease B-cells associated with MS after six months of treatment. Ublituximab is an antibody that targets B-cells carrying the CD20 protein on their cell surfaces. These cells are thought to play a role in MS development. Dr. Matilde Inglese of the Icahn School of Medicine at Mount Sinai in New York will discuss ublituximab's ability to decrease study participants' inflammatory brain lesions. And Dr. Edward Fox of Central Texas Neurology Consultants, the trial's principal investigator, will do a poster-session presentation on the study's patient characteristics and preliminary results as a whole, including safety. The ongoing Phase 2 trial is still recruiting patients with relapsing forms of MS. Researchers are randomly assigning participants to receive intravenous infusions of either ublituximab or a placebo. One of the studyā€™s primary goals is to see how well ublituximab depletes B-cells 28 days after the start of treatment. Another primary goal is to see how safe the therapy is, with the measurement being treatment-related adverse events that patients experience over six months. Ublituximabā€™s ability to reduce relapses will be a secondary measure of the trial. Researchers will assess it after 48 weeks of treatment. Fox, who is the director of the Multiple Sclerosis Clinic of Central Texas, and a clinical assistant professor at the University of Texas Medical Branch in Round Rock, made a ublituximab presentation at the 3rd Congress of the European Academy of Neurology in June. It revealed that the therapy nearly depleted B-cells only four weeks after treatment started. Earlier data suggests that ublituximab can be administered in only one hour. Ocrevus, the only approved MS therapy that targets B-cells with CD20, requires 3 1/2 hours. Although the Phase 2 trial is continuing, the data generated so far supports plans for two Phase 3 trials, TG Therapeutics said. They will randomize patients to receive either ublituximab or Aubagio. The trials, which the company hopes to start by the end of September, will be conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. It allows the FDA to evaluate the design and population size of a trial a company intends to use to seek a drug's regulatory approval. The FDA has refused to approve therapies whose trial design it believed to be flawed. Obtaining a design sign-off before a trial improves the chance of a treatment being approved if it meets the study's objectives.

In Ongoing Phase 2 Trial, Ublituximab Seen to Effectively and Safely Deplete B-cells

TG Therapeutics’ investigational treatment ā€”Ā ublituximab (TG-1101)Ā ā€” led toĀ a near total depletion of B-cells in patients with relapsing forms of multiple sclerosis (MS) taking part inĀ an ongoing Phase 2 trial, the company recently announced. In addition, the company said that ublituximabĀ hadĀ anĀ infusion time as short as one hour,Ā without excessive side…

TG Therapeuticsā€™ B-cell Therapy Could Allow for Rapid Dosing, Early Data Suggest

Early data fromĀ TG Therapeutics’ Phase 2 trial of its B-cell-targeting experimental multiple sclerosis (MS) treatment ublituximab (TG-1101), showed that the drugĀ is well-tolerated and effectively reduces B-cells in the blood. MS therapies that deplete B-cells have been effective in relapsing and progressive forms of MS. Like other B-cell-targeting drugs in…

TG Therapeutics’ Potential Neuromyelitis Optica Treatment Named Orphan Drug by FDA

TheĀ U.S. Food and Drug AdministrationĀ (FDA) has designated TG-1101Ā (ublituximab), aĀ glycoengineered anti-CD20 monoclonal antibody byĀ TG Therapeutics, anĀ orphan drugĀ to advance its development. The drug is a potentialĀ treatment for neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD), two relapsing-remitting autoimmune diseases with similarities to multiple sclerosis. Currently, there are…

Study of Potential Therapy for Relapsing MS That Targets B-Cells Now Recruiting Patients in US

Patients with relapsing multiple sclerosis (MS)Ā are being recruited forĀ aĀ clinical trial evaluatingĀ an experimental monoclonal antibody called ublituximab, the National MS Society announced in a recentĀ newsĀ release. The study, being conducted at seven U.S. sites, will enroll at least 24 patients, but this number can go up to 100. MSĀ is considered to be…

New Phase 2 Trial of a B-cell Antibody, TG-1101, to Treat Relapsing MS Getting Underway

TG TherapeuticsĀ recently announced the opening of a newĀ clinical trial evaluating TG-1101, its glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing-remitting multiple sclerosis (RRMS). The Phase 2 clinical trial, titled “A Placebo-Controlled Multi-Center Phase 2 Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients…