Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 259

Posts Tagged ‘arthritis’

New Vaccine in the Treatment of Rheumatoid Arthritis

Posted by fidest press agency su mercoledì, 10 luglio 2019

CEL-SCI Corporation (NYSE American: CVM) announced that one of its key collaborators from Rush University Medical center, Dr. Adrienn Markovitz an Assistant professor in the department of Orthopedic Surgery, presented new LEAPS data at i-Chem2019, International Conference on Immunity and Immunochemistry in San Francisco, California on Wednesday July 3, 2019. The title of her presentation was “Vaccination with DerG LEAPS peptide conjugates incorporating distinct PG (aggrecan) epitopes protects by different immune mechanisms in the PG G1 domain induced mouse model of rheumatoid arthritis”. Dr. Markovitz also presented a poster on other aspects of her work on modulation of autoimmune arthritis by the tyrosine phosphatase enzyme SHP-1, and identification of immunogenic citrullinated proteoglycan epitopes that may play a role in this disease in mice and humans.The LEAPS work was performed in conjunction with researchers at CEL-SCI on CEL-4000 and a newly discovered LEAPS conjugate, DerG-PG275Cit. Both vaccines were evaluated alone and in combination in the model of proteoglycan [PG] induced arthritis (PGIA) called recombinant PG G1 domain-induced arthritis (GIA), an autoimmune mouse model of rheumatoid arthritis (RA).The conclusion presented by Dr. Markovitz’s was that vaccination with DerG LEAPS conjugates of distinct PG epitopes alone or together were effective at modulating the inflammatory response and arresting the progression of arthritis. As observed previously, the DerGPG70 conjugate modulated disease through up-regulation of Th2, and down-regulation of Th1 and Th17 responses. The results suggest that the two vaccines act mechanistically on different immune responses. The combination of the two vaccines provided not only broader epitope coverage, but also a greater therapeutic effect than either vaccine alone.
The LEAPS platform technology is currently being utilized to develop a therapeutic antigen-specific treatment for RA under a $1.5 million grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH). Upon completion of preclinical and Investigational New Drug (IND) enabling studies for the antigen-specific LEAPS vaccine treatment of RA, CEL-SCI intends to file an IND application with the U.S. Food and Drug Administration.

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New Tool Under Development May Help Arthritis Patients

Posted by fidest press agency su lunedì, 22 ottobre 2018

Study findings presented at the largest rheumatology meeting in the U.S. signal that people with arthritis may soon have information on overall outcome on a medication from a measure that combines the range of possible benefits and the full spectrum of potential side effects at the individual patient level.This study, along with seven other poster presentations of studies conducted with CreakyJoints and the ArthritisPower research registry in partnership with major academic institutions, will be presented during the 2018 ACR/ARHP Annual Meeting in Chicago, IL, October 19-24, 2018.“Based on their goals, a patient might be more willing to risk certain adverse events they consider “mild” or “livable,” if it means they can achieve their treatment target. But, currently, there is no existing resource to help people with rheumatoid arthritis (RA) and their doctors weigh the potential desirability of one medication compared to many other treatment options,” said Liana Fraenkel, M.D., MPH, Professor of Medicine (Rheumatology) at Yale School of Medicine and Section Chief of Rheumatology, VA Connecticut Healthcare System. “Our study aimed to develop a tool that will help RA patients compare the real-world experience of taking different medications, which is essential for informed treatment decisions.” The Global Patient-Reported Outcome Measure (G-PROM) quantifies and compares the distribution of patients’ overall experiences on medications based on trajectory mapping. To inform the trajectory mapping, study authors surveyed participants with RA from the ArthritisPower research registry (n=195) who compared an adverse event (AE) as worse, better, or no better or worse than a referent AE. These data allowed for the construction of a rank ordering of “equivalence classes,” or groups of AEs judged by participants as having a comparable impact on quality of life.A subsequent survey of ArthritisPower participants with RA (n=426), with similar demographic characteristics, were asked to indicate their preference for pairs of outcomes, where each outcome include both a specified level of benefit [little or no improvement, some improvement, and major improvement] and an AE. This resulted in a hierarchy of global outcomes from most preferable to least.With further validation, study authors predict that G-PROM will enable randomized controlled trials to report the percentage of patients classified into each level; thus, providing patients and their rheumatologists with a much clearer understanding of the range and likelihood of the total effects of competing treatment options on their quality of life. “Development of a Rheumatoid Arthritis Global Outcome Measure to Enable Comparisons of Patient Experiences across Treatment Arms in Randomized Clinical Trials,” will be discussed in an oral presentation on Wednesday, October 24 at 9:00am Central.

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Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis

Posted by fidest press agency su lunedì, 22 ottobre 2018

Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis.Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent (ACR50) and 70 percent (ACR70) responses, low disease activity (defined as DAS28(CRP) ≤ 3.2) and clinical remission (defined as DAS28(CRP) < 2.6) at Weeks 12 and 24.Additional FINCH 2 data to be presented include positive results across several patient-reported health-related quality of life measures. Patients receiving filgotinib 100mg or 200mg once-daily experienced greater reduction in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 compared with those receiving placebo (-0.46 and -0.50 vs -0.19; both p<0.001). Patients receiving filgotinib 100mg or 200mg also experienced greater improvements on the Short-Form Health Survey (SF-36) Physical Component Score (PCS) at Week 12 (7.6 and 8.4 vs 4.2; both p<0.001) and on the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Week 12 (8.4 and 10.2 vs 5.2; p=0.007 and p<0.001) compared with patients receiving placebo.Filgotinib demonstrated a safety profile consistent with earlier clinical trials. Rates of serious treatment-emergent adverse events were similar for the filgotinib 100mg, 200mg and placebo groups (5.2 percent, 4.1 percent and 3.4 percent, respectively). The proportion of patients who discontinued study drug due to treatment-emergent adverse events was also similar across groups. Serious infections occurred at similar rates across the three study arms (2.0 percent, 0.7 percent and 1.4 percent, respectively). A total of four cases of uncomplicated Herpes zoster occurred in the filgotinib arms, and one non-serious case of retinal vein occlusion was reported in the filgotinib 200 mg group. Two major adverse cardiovascular events were reported, one in the filgotinib 100mg group and one in the placebo group. No deaths occurred during the study.Filgotinib is an investigational compound and is not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: http://www.clinicaltrials.gov.

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SetPoint Medical Reports Positive Long-term Results from its Clinical Study of Bioelectronic Medicine to Treat Rheumatoid Arthritis

Posted by fidest press agency su venerdì, 22 giugno 2018

SetPoint Medical, a clinical-stage biomedical technology company developing bioelectronic therapy for chronic inflammatory diseases, announced positive long-term data for its first-in-human study using bioelectronic medicine for rheumatoid arthritis (RA). Building on the positive 3-month results that were published in Proceedings of the National Academy of Sciences (PNAS) in 2016, the follow-up through 24 months demonstrated significant, sustained improvement in clinical disease activity scores and disability indices on bioelectronic therapy. The results were presented in a poster session at the Annual European Congress of Rheumatology (EULAR).
Rheumatoid arthritis is a chronic inflammatory disease that affects 1.5 million people in the United States and costs tens of billions of dollars annually to treat. SetPoint is developing a novel bioelectronic medicine platform that stimulates the inflammatory reflex with digital doses of electricity to produce a systemic anti-inflammatory effect.
In this European study, 17 subjects with moderate to severe RA symptoms were implanted with a vagus nerve stimulating device. Early results demonstrated that bioelectronic therapy significantly reduced rheumatoid arthritis symptoms and inhibited cytokine production at three months. Following completion of primary study timepoint, participants had the option of continuing in the follow-up study, and all chose to continue their treatment.All 17 subjects remained on therapy for 24 months. At the 24-month time point, 87% of the subjects reported had clinically meaningful responses by standard EULAR criteria, demonstrating that bioelectronic medicine has the potential to substantially reduce both clinical RA disease activity and patient disability for two years, with no unexpected safety issues. These improvements were maintained in patients with and without concurrent use of biologic agents.“Long-term clinical efficacy is important in the development of cost-effective therapy, and we are pleased to report long-term durability of bioelectronic medicine in RA, with safe and efficacious results that have been maintained for two years,” said Anthony Arnold, Chief Executive Officer of SetPoint Medical.
SetPoint recently initiated a pilot trial evaluating the company’s proprietary device for treatment of drug-refractory RA patients in the U.S.

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