Latest news with #CMSC
Medscape
3 days ago
- Health
- Medscape
Home-Based Exercise as Effective as In-Clinic Care for MS
PHOENIX — In the first randomized phase 3 trial to compare a home-based and facility-based supervised exercise program in patients with multiple sclerosis (MS), outcomes were equivalent at both 16 and 52 weeks. These findings now support home-based exercise as an evidence-based option for patients who prefer to work out at home. Evidence of equivalence from a controlled trial is useful because 'home-based exercise programs might improve both access and adherence for at least some patients,' said study investigator Deborah Backus, PT, PhD, vice president for research and innovation at the Shepherd Center, Atlanta, Georgia. The findings were presented May 29 at the Consortium of Multiple Sclerosis Centers (CMSC) 2025 Annual Meeting. First Phase 3 MS Exercise Trial Conducted at eight participating US centers, the STEP trial was limited to patients with modest walking impairment. An Expanded Disability Status Scale (EDSS) score of 4.5 to 6.0 was among the entry criteria designed to select a population that was still ambulatory but with a need for intervention to preserve function. 'We wanted patients who can walk with some measured and perceived limitations but who were still able to exercise safely,' said Backus. The similar facility- and home-based regimens were based on Guidelines for Exercise in MS (GEMS). In one segment of the trial, 189 patients were randomized to the facility-based (GEMS-F) or the home-based (GEMS-H) programs. In the second segment of the trial, 190 patients were permitted to select their program, creating choice GEMS-F and choice GEMS-H groups that were compared with each other and with the randomized groups. The primary outcome was the timed 25-foot walk test (T25FW). Other outcomes included the 6-minute walk test (6MWT), change in EDSS, and scores on the 12-item MS walking scale (MSWS-12). All outcomes were evaluated at 16 weeks and again at 52 weeks after the exercise programs were initiated. Expressed in least-squares means adjusted for age, sex, and baseline EDSS, the improvement from baseline in T25FW was significant for all study groups and was similar between the GEMS-F and GEMS-H groups, in comparisons within and between the randomized and choice patient populations. Also consistent across all four study groups, a substantial proportion of the improvement was lost between weeks 16 and 52, even if at least a numerical and, in some cases, a statistical advantage was maintained relative to baseline. The 6MWT and MSWS-12 outcomes showed a similar pattern with a substantial improvement at 16 weeks that eroded over subsequent follow-up. Again, there was a numerical advantage at 52 weeks over baseline in all of the groups even if it did not reach significance in every arm. The mean group EDSS scores, which were relatively preserved from baseline to week 16 declined from that timepoint to week 52 in all study groups. There were modest differences in baseline characteristics among the four study groups, but the impact of the COVID pandemic was a major limitation of the study, said Backus. Dropouts by 52 weeks were substantial throughout the study population but were greater among those in the GEMS-H group, who were less likely to return to the facility for assessments. Although exercise regimens in terms of aerobics and resistant training were the same for all groups, Backus acknowledged that there were some differences in access to equipment. For example, participants in the GEMS-F group performed aerobic training on treadmills that were not necessarily available to all of those in the GEMS-H group, even if other forms of aerobic exercise were substituted. Overall, Backus said that exercise intensity and other key aspects, such as coaching, were similar in the GEMS-F and GEMS-H groups. Evidence Base for At-Home Exercise Commenting on the findings, Robert W. Motl, PhD, professor of kinesiology, nutrition, and rehabilitation, University of Illinois, Chicago. and a co-chair of the session where the study was presented, noted that regardless of whether patients completed the exercise program at home or in a facility, all of them were provided with resources for fall prevention, and the lack of serious adverse events in any arm is an important finding from this study. 'With no safety differences and a comparable effect, the results provide an evidence basis for exercising at home, which is more convenient for patients and more cost-effective,' Motl said. Another expert in rehabilitation for patients with MS, Frederick W. Foley, PhD, assistant professor in the Department of Neurology, Albert Einstein School of Medicine, Bronx, New York, agreed that the research provides support for home-based exercise in MS patients. 'There is a need to reduce the dependence of MS patients on care within a hospital or outpatient facility,' said Foley, who was not involved in the trial. 'It is not only less convenient and potentially more costly to receive care in a facility, but patients are also generally more comfortable in their own home,' he said. The loss of benefit from week 16 to week 52, although expected and consistent with other lifestyle interventions, was disappointing. He pointed out that sustained benefit from exercise is elusive regardless of setting. 'The difficulty of achieving long-term benefit from behavioral interventions is pretty well recognized,' Foley said. He called this the 'biggest challenge' for extending an exercise treatment effect.
Medscape
5 days ago
- Health
- Medscape
When MS Meets Menopause: Is It Time to Rethink HRT?
PHOENIX — The overlapping symptoms of menopause and multiple sclerosis (MS) in aging women may warrant hormone replacement therapy (HRT), says one expert, who argues that the potential benefits in easing the combined symptom burden outweigh the therapy's modest risks. It is suspected but not proven that menopause increases the risk and severity of menopausal symptoms such as urinary dysfunction, vasomotor dysregulation, disturbed sleep, and anxiety, but it is known that HRT offers benefit against these, said Kate Petheram, MD, a consultant neurologist for the Royal Sunderland Hospital, Sunderland, UK. In women with MS, 'there is a clear benefit from controlling symptoms associated with menopause even if we do not know yet whether the benefit involves reducing symptoms driven by MS,' Petheram reported. The modest amount of attention paid to the overlap between symptoms of MS and menopause is an important issue for a disease with a 3:1 female to male ratio, said Petheram, in a May 29 presentation at the Consortium of Multiple Sclerosis Centers (CMSC) 2025 Annual Meeting. WHI: Flawed Data Speaking at a symposium dedicated to the topic, Petheram noted that her audience was almost entirely female: a pattern she has observed in previous iterations of the same talk. She urged all neurologists to recognize the interplay between menopause and MS, emphasizing that 30% of people with MS are peri- or postmenopausal women. In the UK, as in the US, prescriptions for HRT plummeted following the 2002 publication of the Women's Health Initiative (WHI): a study involving more than 16,000 participants that was halted after 5.2 years of follow-up. At the time, a widely used combination of conjugated equine estrogen and medroxyprogesterone was linked to several risks — including breast cancer, cardiovascular disease, and stroke — that were deemed to outweigh its symptomatic benefits. Subsequent data have refuted most of those claims, said Petheram, who described the WHI study design as flawed. In fact, current evidence suggests HRT lowers cardiovascular risk. While it does increase the risk of breast cancer, she noted that the increase is modest — and importantly, the risk of dying from breast cancer is not significantly elevated. Yet the reexamination of the evidence has never received the attention needed to shift perceptions shaped by the original WHI study, said Petheram. She described a 'loss of confidence' in HRT that has been only modestly reversed in the UK and not at all in the US. Drawing on published data, she noted that HRT use among menopausal women remains below 5% in the US, compared to 15% in the UK. This poses a particular challenge for women with MS, given the overlap between menopausal symptoms and MS-related complaints. While some issues — such as anxiety and sleep disturbances — may be managed with other therapies, HRT remains one of the most effective treatments for vasomotor symptoms, sexual dysfunction, and urinary complaints. An Effective Option Both historical and emerging evidence suggest that HRT can reduce symptoms shared by MS and menopause, Petheram said. In the observational Nurses' Health Study — a 2016 analysis published in Neurology , for example — women with MS who began HRT 3-10 years after their final menstrual period showed significant improvements across multiple validated quality-of-life measures compared to those who did not use HRT. 'Menopausal women do well on HRT, and they do less well when they quit,' said Petheram, citing multiple studies, including several published in recent years. While she acknowledged that HRT is not a panacea, she emphasized that it remains the only therapy that effectively targets the wide range of symptoms common to both MS and menopause. The ability to address a wide range of symptoms is a significant advantage. Citing fatigue, mood disorders, and sexual and urinary issues as the most common overlapping complaints, Petheram noted that HRT offers additional documented benefits — such as improved bone health — that are meaningful not only to aging women in general, but especially to those with MS. This message is starting to gain traction in the UK, but Jennifer Graves, MD, PhD, director of the Neuroimmunology Research Program at the University of California, San Diego, acknowledged that it will be a tougher sell in the US without targeted education to overcome longstanding biases. 'The WHI is still being taught in some medical schools,' she said. While she agreed that some of the most serious risks linked to HRT in the WHI have since been rescinded — warranting a reassessment of the benefit-to-risk ratio — she also emphasized that aging and menopause in women with MS remain largely overlooked. 'We need greater awareness of the challenges of menopause in women with MS and I think this involves better educating clinicians about how aging, menopause, and MS intersect,' Graves said. Petheram clarified that she doesn't prescribe HRT to women with MS, but she does discuss the overlap between menopausal and MS symptoms — explaining both the potential benefits and risks to help patients make informed decisions. She believes all neurologists should take responsibility for understanding the interaction between menopause and MS in order to better manage overlapping symptoms.
Yahoo
6 days ago
- Business
- Yahoo
TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting
NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentations of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to each presentation are included below. 'We were pleased to present three encore presentations yesterday during the CMSC conference. We continue to be impressed by the BRIUMVI data and look forward to continuing to present updated data throughout the year.'TG PRESENTATIONS:Title: No Association between Decreases in Serum Immunoglobulin Levels and Serious Infections with Long-Term Ublituximab Treatment in Patients with Relapsing Multiple Sclerosis Presenting Author: Dr. Bruce Cree - Weill Institute for Neurosciences, University of California, San Francisco, CA Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR) Presenting Author: Dr. Edward Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Title: Safety and Tolerability of 30-Minute Ublituximab Infusions: Updates from the ENHANCE Study Presenting Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company's website at ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at (NCT03277261; NCT03277248). ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATIONContraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI- treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORTBRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSISRelapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing- remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions. i Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor RelationsEmail: ir@ (8489), Option 4 Media Relations:Email: media@ (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website: Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-05-2025
- Business
- Yahoo
TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting
NEW YORK, May 27, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held May 28-31, 2025 in Phoenix, Arizona. Abstracts are now available online and can be accessed on the CMSC meeting website at Details of the upcoming presentations are outlined below. TG PRESENTATIONS:Poster Presentation Title: No Association between Decreases in Serum Immunoglobulin Levels and Serious Infections with Long-Term Ublituximab Treatment in Patients with Relapsing Multiple Sclerosis Presentation Date/Time: Thurs. May 29, 4:40pm MST/7:40pm ET Session: North 122 ABC Abstract & Poster Number: Platform Presentation – PLA-B6 Presenting Author: Dr. Bruce Cree - Weill Institute for Neurosciences, University of California, San Francisco, CA Poster Presentation Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR) Presentation Date/Time: Poster Session Thurs. May 29, 5:00 - 7:00 pm MST/8pm ET Session: Disease Modifying Therapy - North Exhibit Hall C-E Abstract & Poster Number: DMT08 Presenting Author: Dr. Edward Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Presentation Title: Safety and Tolerability of 30-Minute Ublituximab Infusions: Updates from the ENHANCE Study Presentation Date/Time: Poster Session Thurs. May 29, 5:00 - 7:00 pm MST/8pm ET Session: Disease Modifying Therapy - North Exhibit Hall C-E Abstract & Poster Number: DMT18 Presenting Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company's website at ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at (NCT03277261; NCT03277248). ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATIONContraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI- treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORTBRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSISRelapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing- remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward- looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor RelationsEmail: ir@ (8489), Option 4 Media Relations:Email: media@ (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website: Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p.236.
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04-05-2025
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UK & India Sign Cultural Cooperation Agreement
The UK and India are set for closer cultural ties as the two countries finalized a new 'cultural cooperation agreement' this afternoon in Mumbai. The agreement was locked today by the UK culture secretary Lisa Nandy, who is on a three-day tour of India, alongside Shri Gajendra Singh Shekhawat, India's Minister for Culture and Tourism. More from Deadline Prime Focus Group To Build $400M Entertainment Hub In Heart Of Bollywood Indian Premier League Broadcast On JioStar Shatters Viewership Records In Opening Week Indian Streamer JioHotstar Passes 100 Million Subscribers No real specifics on the agreement have been shared. However, DCMS has said it will involve the British Council in India and the Indian Ministry of Culture, with participation from major UK cultural institutions including Arts Council England, the British Library, and the British Museum all working to launch new partnerships on exhibitions or public programmes that engage the Indian diaspora in the UK. The UK will also work with India to support best practice and expertise on heritage conservation, museum management, and digitisation of collections, including making knowledge contained in South Asian manuscripts more widely accessible. Nandy is in India alongside a UK delegation, which includes delegates from the British Film Institute and the Science Museum. While in India, Nandy toured Yash Raj Films Studio and gave a keynote at the World Audio Visual and Entertainment Summit (WAVES) in Mumbai, where she dismissed calls for a steamer levy in the UK. Speaking with Variety at the event, Nandy said: 'We would be very reluctant to introduce additional levies at a time when business is booming. The U.K. is open for business, and we're able to attract huge amounts of investment that help to create good jobs in every part of the country.' Last month, the influential UK Culture, Media & Sport Committee (CMSC) officially recommended a 5% streamer levy to the government and said this should be enshrined into law if the industry fails to introduce it within a year. Informally titled the 'Kosminsky Levy' after its main backer, Wolf Hall director Peter Kosminsky, the idea gained tonnes of traction during the recent CMSC inquiry into British film and high-end TV (HETV). In their final report, the CMSC said its recommendations 'should help [the industry] ride out future storms' while calling on government and industry 'not to become complacent about the UK's status as the 'Hollywood of Europe'.' Best of Deadline Brad Pitt's Apple 'F1' Movie: Everything We Know So Far Everything We Know About 'Nine Perfect Strangers' Season 2 So Far 2025-26 Awards Season Calendar: Dates For Tonys, Emmys, Oscars & More
