Author Archives: Alberto Molano, PhD

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for QyScore, a cloud-based imaging software for the automated quantification of key magnetic resonance imaging (MRI) markers of central nervous system (CNS) disease. MRI is an important tool for diagnosing multiple sclerosis and other CNS disorders. By…

Results from a large observational study of pregnant women with multiple sclerosis (MS) treated with an interferon (IFN) beta-1a, like Rebif, before and during the first trimester showed no elevated risk of a miscarriage or ectopic pregnancy compared to those not using the medicine. This finding was presented at…

The relative risk of developing cancer was found to be higher in multiple sclerosis patients who more frequently switched between disease-modifying treatments, according to a study. In addition, researchers found an increased incidence of cancer in male MS patients from 20 to 50 years old, and in female MS patients over 50. The data were reported in the study “Cancer Risk and Multiple Sclerosis: Evidence From a Large Italian Cohort,” published in the journal Frontiers in Neurology. Previous research has discovered that MS and cancer may share some abnormal functions of the immune system. To better understand the incidence of cancer in MS patients, and evaluate the impact of disease-modifying treatments (DMTs) on cancer risk, a team led by researchers at the University of Catania, Italy, compared a database of MS patients between 2003 and 2013 in Catania (the second largest city of Sicily in Italy) with the Integrated Cancer Registry of Catania-Messina-Siracusae-Enna, which collects information about cancer in the general population of that particular geographic area. During the time period analyzed (2003–2013), 2,730 people were diagnosed with MS. Of these, 1,180 patients satisfied the inclusion criteria and were enrolled in the study (67.1% females; mean age of 41.2 years), and of those, a total of 36 incidences of cancer were observed. Investigators then analyzed the number of cancer cases according to the “expected” number of cases in the Catania community based on the Integrated Cancer registry. These are the “standardized incidence ratios,” or SIR. If the observed number of cancer cases in MS patients equals the expected number, the SIR is 1, meaning no increased cancer risk. If more cases are observed than expected, the SIR is greater than 1, meaning increased risk. If fewer cases are observed than expected, the SIR is less than 1, meaning less risk. The results showed that the cancer risk was not significantly increased in the MS population as a whole (SIR of 1.18). However, when the analysis was focused on specific population subgroups, stratified based on age and gender, men between 20 and 50 years old (SIR of 2.84), and women over 50 (SIR of 1.82) showed a significantly higher risk of developing cancer. These results suggested that some MS subpopulations may be more susceptible to developing cancer. The team also investigated the effects of different MS treatment strategies on the relative risk (RR) of developing cancer. MS patients were divided into four subgroups: patients not treated with any disease-modifying treatment (DMT), treated with one DMT (“no switch”), treated with two DMT (“one switch”), and treated with more than two DMTs. The RR of developing cancer was not significantly higher in the “no DMT” group, and slightly increased in the “no switch” group, but it was 1.99 (nearly two times higher) in the “one switch” group, and 3.38 (more than three times higher) in the group who switched at least twice. Based on the results, the team hypothesized that “MS patients experiencing therapeutic failure with different immunomodulating and/or IS (immunosuppressive) [agents] could have an enhanced risk of cancer, because being exposed to different molecules with different mechanisms of action may negatively influence the innate and adaptive immune systems and make these patients more sensitive [to] carcinogenesis [cancer formation].” In terms of cancer types, a significantly higher incidence of genitourinary and thyroid cancers was observed. Additional analysis showed that age, age at MS onset, disease duration, and more that two DMT switches were associated with a higher risk of developing cancer. "Our results demonstrated that cancer risk was not increased in our MS population; but age and sex different distribution may partly drive cancer risk. Higher cancer risk in MS patients switching more than two DMTs should [be] take[n] into account in treatment decision making,” the team concluded.

Early, positive safety results from a Phase 1 trial testing a potential immunotherapy, ATA188, in people with progressive multiple sclerosis will be detailed at the 5th Congress of the European Academy of Neurology (EAN) late next month, its developer, Atara Biotherapeutics, announced. ATA188 is an investigational and “off-the-shelf”…

A study suggests that it may be possible to create synthetic speech based on recordings of brain activity in people with irreversible speech loss due to neurological ills, such as multiple sclerosis (MS), Parkinson's, or stroke. The system uses tiny electrodes implanted on the surface of the brain that directly records activity that controls speech, and feed that information into a brain-machine interface to generate natural-sounding speech. The study, led by researchers at University of California San Francisco (UCSF), is titled "Speech synthesis from neural decoding of spoken sentences," and published in the journal Nature. According to the team, this new system represents a major advancement over existing technologies: namely, assistive devices that track very small eye or facial muscle movements to generate text or synthesized speech. The world-renowned scientist Stephen Hawking, for instance, used an infrared switch mounted on his eyeglasses to detect when he moved his cheek. When a cursor moving through a keyboard displayed on his computer screen reached a desired word, Hawking stop it with a twitch of his cheek. But this is a laborious, error-prone, and slow process, typically permitting a maximum of 10 words per minute, compared to the 100 to 150 words per minute of natural speech. This newly developed technology detects the specific brain activity that controls the nearly 100 muscles which continuously move the lips, jaw, tongue, and throat to form words and sentences, and feeds this information to a virtual vocal tract (an anatomically detailed computer simulation). A synthesizer then converts these vocal tract movements into a synthetic human voice. It is being developed in the laboratory of Edward Chang, MD, a neurosurgeon at the UCSF Epilepsy Center and member of the UCSF Weill Institute for Neuroscience. “For the first time, this study demonstrates that we can generate entire spoken sentences based on an individual’s brain activity,” Chang said in a UCSF news release written by Nicholas Weiler. “This is an exhilarating proof of principle that with technology that is already within reach, we should be able to build a device that is clinically viable in patients with speech loss.” Chang specializes in surgeries to remove brain tissue in patients with severe epilepsy, and who do not respond to medications. To prepare for these operations, neurosurgeons place high-density arrays of tiny electrodes onto the surface of the patients’ brains, a technique called electrocorticography or ECoG. ECoG helps surgeons pinpoint the specific brain area triggering patients’ seizures, and also allows them to map out key areas, such as those involved in language, they want to avoid damaging. Chang and colleagues used ECoG to record the brain's electrical activity in people reading aloud several hundred natural sentences, and used the information collected to construct a map of those brain areas that control specific parts of the vocal tract. Of note, the persons analyzed were five volunteers with intact speech being treated at UCSF Epilepsy Center. The team then used linguistic principles to determine which vocal cord, tongue, or lip movements were needed to produce specific sounds in the spoken sentences. Researchers then created a “virtual vocal tract,” consisting of a decoder that transformed brain activity patterns produced during speech into movements of the virtual vocal tract, and a synthesizer that converted these vocal tract movements into a synthetic voice. A YouTube video included in the news article helped to illustrate the synthetic voice is understandable. Researchers put it to the test by recruiting hundreds of listeners through Amazon Mechanical Turk (MTurk), an internet crowdsourcing marketplace. These transcribers accurately identified 69 percent of synthesized words from lists of 25 alternatives, and transcribed 43 percent of sentences with perfect accuracy. When the list of alternatives was increased to 50 words to choose from, the overall accuracy dropped to 47 percent, but listeners were still able to understand 21 percent of synthesized sentences perfectly. “We still have ways to go to perfectly mimic spoken language,” said Josh Chartier, a bioengineering graduate student in the Chang lab and study co-author. “We’re quite good at synthesizing slower speech sounds like ‘sh’ and ‘z’ as well as maintaining the rhythms and intonations of speech and the speaker’s gender and identity, but some of the more abrupt sounds like ‘b’s and ‘p’s get a bit fuzzy. Still, the levels of accuracy we produced here would be an amazing improvement in real-time communication compared to what’s currently available.” The team is now testing higher-density electrode arrays, and more advanced machine learning algorithms to further improve the synthesized speech. Although the study was conducted in volunteers with normal speaking ability, its researchers believe their approach could one day restore a voice to people who have lost the ability to speak due to neurological damage, much as robotic limbs controlled by the brain restore movement. "Decoded articulatory representations were highly conserved across speakers, enabling a component of the decoder to be transferrable across participants," the study concluded. "Furthermore, the decoder could synthesize speech when a participant silently mimed sentences. These findings advance the clinical viability of using speech neuroprosthetic technology to restore spoken communication."

Roche Canada is contributing $2.125 million to the Canadian Prospective Cohort Study to Understand Progression in MS (CanProCo), a partnership initiative with the Multiple Sclerosis Society of Canada, the Brain Canada Foundation, and Biogen Canada. The addition of Roche Canada to the collaboration raises the…

In partnership with the Canadian Institutes of Health Research, the MS Society of Canada has announced $1.5 million to fund research over five years on the effects of cannabis on multiple sclerosis (MS) symptoms and disease progression. Studies have shown that for each 10-degree increase in latitude, patients newly diagnosed…

Immunic Therapeutics has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy for relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a…

Multiple sclerosis (MS) patients eat a more limited diet, with a lower average of 31 nutrients, including zinc, thiamin, and iron, when compared with healthy controls, a study shows. Blood tests also showed that MS patients had significantly lower iron levels, a different fatty acid composition in their red blood…

An international survey of caregivers and adults with neurological diseases, including multiple sclerosis (MS), revealed that spasticity is a hidden burden, having a negative effect on the ability to perform everyday tasks, and that relieving its symptoms significantly improves patients’ quality of life. The survey was presented by…

Banner Life Sciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Bafiertam (monomethyl fumarate), a novel bioequivalent of Biogen’s Tecfidera (dimethyl fumarate) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Final approval is expected no later…

Multiple sclerosis (MS) patients who reported food allergies showed a 27 percent higher cumulative rate of flare-ups over the course of their disease, and more than twice the likelihood of having active inflammatory lesions, a new study shows. The study, “Food Allergies are Associated with Increased Disease Activity…

The U.S. Food and Drug Administration (FDA) has approved BrainStorm Cell Therapeutics‘ request to open a Phase 2 clinical trial testing the safety and effectiveness of its proprietary NurOwn mesenchymal stem cell (MSC) treatment in progressive multiple sclerosis (MS) patients. The request was in the form of Investigational New Drug…

Tysabri (natalizumab) was found to be superior to interferon beta (IFN-β) in a small, 12-month study with relapsing-remitting multiple sclerosis (RRMS) patients, significantly decreasing their disability levels, its researchers report. A vast majority — 90 percent — of Tysabri-treated patients experienced no relapses during the study period,…

The U.S. Congress is supporting with $5 million the National Neurological Conditions Surveillance System (NNCSS), an initiative to be launched by the Centers for Disease Control and Prevention (CDC) to help researchers better understand who develops neurological disorders and why. The NNCSS was authorized by Congress as a part…

Nurses who specialize in treating multiple sclerosis (MS) patients in the U.K. are handling heavier caseloads than recommended or preferred, resulting in patients going without the necessary care and support they deserve, the MS Trust reports. Particularly, the 2018 report notes that newer treatments require more complex and careful monitoring. However, it…

Multiple sclerosis (MS) relapses can be challenging for some patients, and better engagement is needed between patients and their healthcare providers, a study focused on patient experiences has found. The study, titled “Relapse prevalence, symptoms, and health care engagement: patient insights from the Multiple Sclerosis in America 2017 survey,”…