clinical trials

President Obama’s signing of the 21st Century Cures Act on Dec. 13 is expected to bring real change to those living with multiple sclerosis (MS). The legislation will lead to better research and clinical trials. It also puts increased weight on the role patients play in developing treatments for their…

Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were not helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society. The trial is an open-label study, meaning…

Promising data from a small Phase 2a clinical trial sponsored by RedHill Biopharma for an antibiotic designed to fight certain infections suggests that adding the drug candidate to interferon treatment reduced relapse rates and brain lesion formation in patients with relapsing forms of multiple sclerosis (MS). This novel treatment approach was based on…

Multiple sclerosis (MS) patients now taking part in a Phase 2b clinical trial testing the efficacy and safety of the antibody GNbAC1 will be invited to continue with treatment for two more years under a planned extension study, the biopharmaceutical companies GeNeuro and Servier recently announced. Several MS therapies rely on the capacity of antibodies to…

Data from the CARE-MS II clinical trial showed that Lemtrada (alemtuzumab) can lessen pre-existing disabilities in patients with relapsing-remitting multiple sclerosis (RRMS) who failed to respond adequately to previous disease-modifying therapies, according to a study of the trial’s data. The treatment was evaluated against Rebif (interferon beta-1a) therapy. The study, “Alemtuzumab…

AXIM Biotech has closed on a private funding round that will enable it to continue clinical trials for a variety of conditions, including its pharmaceutical candidate MedChew Rx, a patented cannabinoid release chewing gum for treating pain and spasticity in multiple sclerosis (MS). According to a press release from SECFilings.com,…

Results from a Phase 2 clinical trial showed that treatment with Ampyra (prolonged-release fampridine) brought both physical and psychological benefits to patients with multiple sclerosis (MS). These findings, from the MOBILE study (NCT01597297), were published under the title, “Prolonged-Release Fampridine Treatment Improved Subject-Reported Impact Of Multiple Sclerosis: Item-Level Analysis Of The…

AXIM Biotechnologies  announced it has secured financing from private sources to continue its testing of medical cannabinoid products as potential treatments for multiple indications, including pain and spasticity in people with multiple sclerosis (MS). Specifically, AXIM  is testing pharmaceutical delivery systems and active ingredients for its medical marijuana line. “This financing provides us with…

Getting more African-Americans and other minority groups to take part in clinical research into treatments for multiple sclerosis (MS), and identifying and tackling continuing disparities in efforts that affect patient care, will be the focus of a project led by the nonprofit group Accelerated Cure Project for Multiple Sclerosis (ACP) and supported…

Damaging immune system defects seen in patients with multiple sclerosis (MS) can be repaired using a simple stem cell approach, according to a new study by researchers in China and the U.S. The study, “Umbilical Cord-Derived Mesenchymal Stem Cells Reversed The Suppressive Deficiency Of T Regulatory Cells From Peripheral Blood Of…

Abide Therapeutics announced that Celgene has opted to obtain the rights, outside of the United States, to ABX-1431, Abide’s endocannabinoid system modulator being developed to treat neurological diseases, including multiple sclerosis (MS), by reproducing within the body the physical benefits (minus the psychotropic effects) of cannabis. ABX-1431 is an…

Actelion announced that it will investigate the therapeutic potential of a new, oral combination therapy with ponesimod and Tecfidera (dimethyl fumarate) as a treatment for relapsing multiple sclerosis (RMS). The Phase 3 clinical study, being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), aims to find…

Active Biotech acknowledged in an update on laquinimod, the oral small molecule being developed by Teva Pharmaceutical Industries to treat multiple sclerosis (MS) and Huntington’s disease (HD), that the U.S. Food and Drug Administration (FDA) has rescinded the special protocol assessment given to a Phase 3 study of the treatment in…

Results from the extension period of a Phase 2 trial, assessing ozanimod as a potential treatment for relapsing-remitting multiple sclerosis, showed that the drug can effectively and safely improve clinical measures of RRMS after two years of treatment. The announcement was made by Celgene International Sàrl, a subsidiary of Celgene Corporation,…

The U.S. Department of Health and Human Services (HHS) recently announced policy changes designed to make information about clinical trials of investigational drugs, biologics and products more widely available to the public, issuing amended rules that specify the requirements for registering clinical trials and for submitting summary results to its ClinicalTrials.gov website. The…

A presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress gave patients with progressive multiple sclerosis (MS) a reason for optimism, as Novartis reported that siponimod (BAF312) reduced the risk of disability progression in a Phase 3 study of patients with secondary progressive (SP) MS.

Autoimmune side effects during five years of Lemtrada (alemtuzumab) treatment were generally not serious and mainly affected the thyroid, according to an analysis of patients in three large, Phase 3 clinical trials of the therapy. The data were presented at the Free Communications 1 session of the European Committee…

Novartis recently announced positive results from the ACROSS study, which is assessing the clinical effect of Gilenya (fingolimod) in 10-year disability outcomes in people with relapsing-remitting multiple sclerosis (RRMS). The results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Sept. 14-17 in London. The ACROSS study…

GeNeuro announced that it has reached — more quickly than expected — the halfway mark for patient enrollment in its Phase 2b study, CHANGE-MS, assessing GNbAC1 as a therapy for relapsing-remitting multiple sclerosis (RRMS). Patient recruitment is continuing at sites across Europe. The company also reported on the trial’s design in a poster presentation, “A placebo…

Merck recently presented new efficacy data from its three Phase 3 clinical trials, showing that a relatively short course of treatment with Cladribine tablets led to long-term reductions in annualized relapse rate (ARR) in people with relapsing multiple sclerosis (RMS). The data were given in two oral presentation at the 32nd Congress of the…

Leustatin (cladribine) tablets, an investigational drug, were shown to be effective at reducing annual relapse rates, not only in MS patients, but also in patients with a first demyelinating event who later converted to a clinically defined multiple sclerosis diagnosis. The results were shared in a presentation titled “Cladribine tablets in the ORACLE-MS…

Positive new data from Phase 3 clinical trials assessing Ocrevus (ocrelizumab) as a treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) were recently announced by Roche, the company responsible for marketing and developing this investigational therapy. The results are being presented at the 32nd Congress of the…

The importance of getting a representative group of people, also known as subjects, engaged in  clinical trials cannot be understated. There is so much that we need to know when it comes to multiple sclerosis, but the picture cannot be complete unless the cohort of subjects includes people from…

Patients with secondary progressive multiple sclerosis (SPMS) who were treated with BAF312 (siponimod), a sphingosine-1-phosphate (S1P) inhibitor, in a Phase 3 clinical trial showed a  significantly reduced risk for disability progression compared to placebo, Novartis recently announced. BAF312 is a selective modulator of specific types of the S1P receptor. This receptor is…

The National Multiple Sclerosis Society  announced that it has dedicated more than $1 million to support a clinical study at the University of Iowa that will compare two types of diet and their effectiveness in easing fatigue in people with multiple sclerosis (MS). “The National MS Society is committed to identifying wellness solutions to…

Relapsing multiple sclerosis patients who begin taking Betaferon/Betaseron (interferon beta-1b) immediately after the first MS-related neurologic symptoms appear may realize slower disease progression than those who delay treatment, according to a study evaluating the therapy’s effects over a decade in patients enrolled in a Phase 3 clinical trial. The study, “The 11-year long-term follow-up…

There are several key questions that a participant will want answered before enrolling in a clinical trial. Many are listed here, but patients should feel free to ask study coordinators any additional questions they may have so their concerns are well addressed before the trial starts. It is important for a study participant to learn as…

The Patient-Centered Outcomes Research Institute (PCORI) recently awarded a sum of $5.5 million to two researchers at the University of California, San Francisco (UCSF). Bardia Nourbakhsh, MD. (Credit: UCSF) Bardia Nourbakhsh, MD, a clinical fellow in Neurology, received a $2 million grant to conduct a randomized, double-blind, placebo-controlled clinical trial to…

This idea is so simple. But it has been overlooked for years until the partners of Gray Consulting, a Philadelphia firm, connected the dots and developed a better way to engage and retain people in clinical trials.  Scott Gray, CEO, took time out to speak with me about…

RedHill Biopharma announced that the final patient has completed the last step of its Phase 2 clinical study (CEASE-MS) of RHB-104 as a potential treatment for people with relapsing-remitting multiple sclerosis (RRMS). RHB-104 is an antibiotic oral medication that blocks inflammation in addition to killing bacteria. RHB-104 was originally developed as a treatment for…