clinical trials

Dutch regulators have signed off on AXIM Biotechnologies’ clinical trial plans for a chewing gum that offers controlled release of cannabinoids to treat multiple sclerosis patients’ pain and spasticity. The Dutch Medicines Evaluation Board’s sign-off on MedChew Rx means AXIM can start trials. A leader in cannabinoid research, New York-based AXIM…

Mallinckrodt Pharmaceuticals is seeking 66 participants for a clinical trial to determine the safety and effectiveness of its injected therapy H.P. Acthar Gel as a treatment for acute relapses in people with relapsing-remitting multiple sclerosis (RRMS). MS relapses are flare-ups of central nervous system inflammation that damage the myelin coating that protects nerve cells. The damage disrupts the transmission of impulses between the cells, causing spikes in MS symptoms. For severe relapses that interfere with a person’s mobility, safety or ability to function, most neurologists recommend corticosteroid treatment administered intravenously or taken orally. Steroids can also be administered by injection of a gel under the skin. H.P. Acthar Gel is designed to provide extended release of steroids in the body. The trial will evaluate whether the gel is an effective treatment for RRMS patients who have been unable to recover from a relapse after receiving high-dose intravenous or oral steroids. Researchers will randomly assign participants to receive either H.P. Acthar Gel or a placebo, delivered by injection once a day for 14 days. Follow-up visits will be required at 14, 28 and 42 days. The study's main objective will be seeing whether patients' disability improves. Researchers will use a standard tool for measuring disability known as the Expanded Disability Status Scale.  Other objectives will include seeing how the therapy affects patients' fatigue, quality of life, workplace productivity, and use of healthcare resources. Participants must have a confirmed diagnosis of RRMS, be older than 18 years of age, and have experienced a relapse within 29 days of enrolling in the trial. For more information about enrollment criteria and how to participate in the trial, please contact Valerie Carvajal at (800) 556-3314 or by email at [email protected]. The National Multiple Sclerosis Society announced in an MS trial alert that Mallinckrodt will be  enrolling participants in Tucson; Fort Collins, Colo.; Tampa; Atlanta; Savannah, Ga.; Northbrook, Ill.; Fort Wayne, Ind.; Indianapolis; Kansas City, Kan.; New York; Cleveland; Dayton, Ohio; Dallas; Round Rock, Texas; San Antonio; Salt Lake City; Richmond, Va.; and Tacoma, Wash. Without clinical trial participation there is no way for patients to obtain new medicines or for scientists to ultimately find a cure for MS. The National MS Society encourages participation. It has developed a guide for patients who want to take part in studies called “Participating in Clinical Trials.” It covers the basics of participation, benefits versus risks, patient protection, costs and other important issues about trials.  

Atara Biotherapeutics has received a green light to enroll U.S. patients into a Phase 1 trial of ATA188 for progressive or relapsing-remitting multiple sclerosis (MS). The study was initially launched in Australia, but with the U.S. Food and Drug Administration (FDA) having cleared the company’s application, the trial…

A Phase 3 clinical trial evaluating AB Science’s masitinib as a treatment for progressive multiple sclerosis can continue without having to add patients, an independent review board has decided. The decision indicates that the therapy has been effective enough that its population base does not need to be expanded, the…

MMJ International Holdings is seeking a patent for a part-cannabinoid and part-non-cannabinoid treatment for multiple sclerosis and other diseases. The company said in a news release that it filed the patent request ahead of Phase 2 clinical trials of the formulation.  The therapy was developed by MMJ Bioscience, an affiliate of MMJ International…

Clomipramine, an approved antidepressant, shows potential in treating people with progressive multiple sclerosis (MS)  — a disease form with few treatments — by protecting nerves from various processes thought to underly progressive MS, early research shows. The lab and animal study, which focused on already-approved treatments, was titled “Systematic…

Using balloons to enlarge veins so that more blood flows out of the brain and spinal cord fails to help multiple sclerosis patients, according to a clinical trial in Italy. Researchers said the procedure did not improve their functioning or reduce their brain lesions — areas where toxic protein build-ups…

 Novartis' Gilenya and interferon beta-1b-based therapies stop multiple sclerosis patients' cognitive decline, a Phase 4 clinical trial shows. Gilenya (fingolimod) also reduces patients' relapses and the number of their brain lesions — areas where a protein coating that protects nerve cells has deteriorated, researchers found.

Scientists announced positive and encouraging outcomes from two clinical studies — running as part of the larger Human Vaccines Project — aiming to unravel the mechanisms that underlie our immune system’s ability to fight disease. The results are expected to shed light on unknown aspects of the immune system that scientists at the Human Vaccines Project, a public-private partnership, hope to translate into new trials for diseases linked to the immune system, such as multiple sclerosis. Results from the trials — the Human Immunome Program and the Immunity to Hepatitis B Vaccine study — were recently presented at the World Vaccine and Immunotherapy Congress in San Diego, California. In the ongoing Human Immunome Program, researchers are trying to fill a major knowledge gap in the components and mechanisms of the immune system that allow it to recognize various threats, from viruses, parasites and bacteria to cancer cells. They are using blood samples from healthy people to analyze, at an unprecedented depth, the whole repertoire of genes that make up the surface receptors of immune B- and T-cells, the core cells of the immune system’s defence mechanisms. Results will likely advance how scientists diagnose and treat various diseases, and could prompt the development of new, improved vaccines. "We are studying the immune systems of healthy individuals to identify common elements, which could be important for facilitating new and improved vaccines," James E. Crowe Jr., MD, director of Vanderbilt University Medical Center's Vaccine Center, the leading scientific institution of the Human Immunome Program, said in a press release. Researchers will cross the sequencing information with participants' microbiome composition — the natural community of microbes that reside in an organism and are key for a healthy immune system — and other health and sociodemographic characteristics. "We also plan to expand these studies to complete the catalog across different demographics and geographies and compare healthy subjects with individuals with immune-mediated diseases such as multiple sclerosis, cancer and Alzheimer's, which could also reveal novel diagnostic markers," Crowe said. The second study, the Immunity to Hepatitis B Vaccine trial — currently recruiting participants — aims to understand why some people achieve protection against Hepatitis B after a single vaccine shot, while others require up to three immunizations to acquire full immunity. Understanding why the immune system responds differently in individuals can help researchers improve existing vaccines and potentially lead to one-shot vaccines that provide long-term immunity for all populations. Researchers in this study are analyzing genes belonging to the innate-immune system — a general immune system response, not one tailored to specific threats — and observing that activation of these genes in certain immune cells can predict who will be a responder after a single shot of the Hepatitis B vaccine. Preliminary results of the Immunity to Hepatitis B Vaccine study were delivered in two separate sessions at the congress. One was given by Manish Sadarangani, director of the Vaccine Evaluation Center of the University of British Columbia and BC Children's Hospital Research Institute, and the by and Richard Scheuermann, director of the J. Craig Venter Institute in La Jolla, California. "These preliminary data points toward strategies to understand why some people respond better to vaccines than others," Sadarangani said. "Using single cell analyses, we now have the opportunity to probe vaccine-induced responses more effectively, to not only learn what happens immediately after vaccination, but to monitor responses over time and utilize machine learning to eventually predict the human immune response to vaccines," added Scheuermann. Wayne C. Koff, president and chief executive officer of the Human Vaccines Project, emphasized that researchers are optimistic with the results obtained so far, as they "provide important insights into the scale and complexity of the human immune system and how vaccines confer protective immunity." "With our network of academic and corporate partners, we aim to build on these findings and decode the human immune system, giving the world the tools required to advance the development of future vaccines and therapies to defeat major global diseases," Koff concluded.  

Sweden's Active Biotech said its experimental therapy Laquinimod failed to meet the primary and secondary objectives of Phase 2 clinical trial evaluating the drug's potential to treat primary progressive multiple sclerosis. Laquinimod, also known as Nerventra or ABR-215062, was developed by Active Biotech and Israel's Teva Pharmaceutical Industries. The drug targets inflammation and degeneration in neurological tissue. Preclinical studies using animal models of multiple sclerosis showed that laquinimod regulated inflammatory and immune responses in these animals, reducing disease progression. The ARPEGGIO Phase 2 study aimed to evaluate laquinimod's efficacy, safety and tolerability in PPMS patients. Its primary endpoint was brain atrophy as defined by percent brain volume change. Secondary goals included time to disability progression, change in timed 25-foot walk, and number of new T2 lesions. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 374 individuals. Initially, the study aimed to evaluate two doses of laquinimod — 0.6 and 1.5 mg/day — in PPMS compared to placebo. However, the highest dose was discontinued in January 2016 after some participants reported adverse cardiovascular events. In a Dec. 1 press release, Active Biotech said the lower dose of laquinimod failed to slow both the rate of brain atrophy and disease progression. “There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg,” said the company's president and CEO, Helén Tuvesson. The trial revealed a similar safety profile to that observed in previous studies in relapsing-remitting MS patients (RRMS). The most common adverse reactions were headache, nasopharyngities, upper respiratory tract infection,and back pain. Results of the ARPEGGIO trial will likely be presented at a future scientific conference and published in a scientific journal. Earlier this year, Active Biotec stopped developing laquinimod as a potential RRMS treatment after a Phase 3 study failed to achieve its primary goal: slowing disease progression. Laquinimod is also being evaluated as a potential therapy for Huntington’s disease in a Phase 2 clinical trial.

Oral steroids may be cheaper, more convenient and less invasive alternatives than intravenous steroids in treating relapses in multiple sclerosis (MS) patients, suggests an analysis of five randomized trials. Glucocorticoids are recommended as the first line of treatment for MS relapses. Yet recent studies have shown no significant difference between…

Flex Pharma has completed enrolling multiple sclerosis patients in a Phase 2 clinical trial in Australia testing FLX-787’s ability to alleviate muscle stiffness, spasms, and cramps. The compound has a mechanism of action that Flex believe will generate fewer side effects than other muscle-relaxing medications. The company is also…

Results of a Phase 1 clinical trial in healthy volunteers show that PTL101, an oral cannabidiol compound, is a safe and effectively delivered potential treatment of spasticity in multiple sclerosis (MS) and for conditions like epilepsy, Harvest One Cannabis announced. These findings were published in the journal Clinical Pharmacology in Drug Development, in the study…

A pregnancy hormone called estriol may be effective in controlling relapses in women with multiple sclerosis (MS), says a researcher at the University of California, Los Angeles (UCLA). In clinical trials, estriol has also lowered fatigue and improved thinking — work that originated in Rhonda Voskuhl’s quest to understand…

Celgene released the results of two Phase 3 trials showing that patients with relapsing multiple sclerosis (MS) who were treated with ozanimod had lower relapse rates and fewer MRI brain lesions compared to those given a current first-line therapy, Avonex (interferon β-1a). These results will be used to support a request…

MMJ BioScience, an affiliate of medical cannabis research company MMJ International Holdings, has hired a principal investigator to lead clinical trials exploring potential therapeutic applications of cannabinoids in progressive multiple sclerosis (MS). Dr. Bianca Weinstock-Guttman, a neurology professor at the State University of New York at Buffalo, is executive director…

Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate) in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartis’ Gilenya (fingolimod) — making immune…

Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows that ALKS 8700 — an investigative therapy developed by Alkermes to treat relapsing forms of multiple sclerosis — has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.

Potential new ways of capturing disease progression in multiple sclerosis (MS) patients — including those with chronic as opposed to active inflammation — are coming to the fore as analyses continue into the huge amounts of data collected during pivotal clinical trials that led to Ocrevus’ approval, a leading Genentech researcher…

Celgene‘s investigative drug ozanimod has been shown to be more efficient than an intramuscular injection of interferon beta-1a (marketed as Avonex by Biogen) in reducing relapses and disease progression in patients with relapsing multiple sclerosis (MS), according to results of the two-year Phase 3 RADIANCE trial. The findings were…

GeNeuro‘s humanized antibody GNbAC1 promotes the rejuvenation of the myelin coating that protects nerve cells in patients with 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 the Heinrich-Heine-University Düsseldorf in Germany presented the results at the 7th…

The Japanese company MediciNova‘s anti-inflammatory agent ibudilast slows multiple sclerosis patients’ brain shrinkage and their loss of the protective myelin coating around nerve cells, a Phase 2 clinical trial shows. Robert J. Fox of Ohio’s Cleveland Clinic Neurological Institute presented the results at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28.

Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study — the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…

A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy, with the University of Colorado School of Medicine, presented the study at…

Ozanimod (RPC1063) was seen to lower relapse rates and reduce brain and spinal cord lesions among patients with relapsing multiple sclerosis (MS) participating in a Phase 3 study of the treatment. Giancarlo Comi, from the Vita-Salute San Raffaele University, in Italy, announced the results in a presentation during the ongoing…

This is a special edition of Multiple Sclerosis News Today's daily Alexa Flash Briefing, covering the latest news from the 7th Joint ECTRIMS-ACTRIMS Meeting currently underway in Paris, France. The MS News today team in on-site at the conference, providing exclusive coverage of the presentations and speakers.

Genentech’s Ocrevus (ocrelizumab) improved the vision of people with relapsing multiple sclerosis better than the widely used therapy interferon beta-1a, according to clinical trial findings presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris. Dr. Laura Balcer of the department of neurology at New York University made the presentation, titled “Effect…

While Tysabri (natalizumab) failed to slow worsening disability in people with secondary progressive multiple sclerosis (SPMS) in a Phase 3 trial, researchers now suggest that the treatment did improve walking and arm function in people with advanced disability. Researchers presented new analyses of data from the ASCEND trial (…

MD1003, a high-dose biotin developed by MedDay, slowed or prevented further disease progression among progressive multiple sclerosis (MS) patients in a Phase 3 clinical trial, researchers announced at the Oct. 25–28 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. The effects of the treatment were seen to be upheld over…

Novartis’ Siponimod led to a dramatic drop in the number of inflammation patches in the brains and spinal cords of secondary progressive multiple sclerosis patients, according to a Phase 3 clinical trial. Robert Fox of the Cleveland Clinic’s Mellen Center for Treatment and Research in Multiple Sclerosis presented the findings…