Breaking News
February 23, 2019 - Acupuncture Could Help Ease Menopausal Symptoms
February 23, 2019 - Researchers use AI to detect early signs of Alzheimer’s
February 23, 2019 - On recovery, vulnerability and ritual: An exhibit in white | News Center
February 23, 2019 - Memory Stored in Unexpected Region of the Brain
February 23, 2019 - Several health experts worldwide gather at EUDONORGAN event
February 23, 2019 - Discovery of potent compound in native California shrub may lead to treatment for Alzheimer’s
February 22, 2019 - Researchers create new map of the brain’s own immune system
February 22, 2019 - ICHE’s reviews on surgical infections, unnecessary urine tests, and nurses’ role in antibiotic stewardship
February 22, 2019 - UK Research and Innovation invests £200 million to create new generation of AI leaders
February 22, 2019 - Takeda collaboration to boost fight against Alzheimer’s and other neurodegenerative diseases
February 22, 2019 - Heavy drinking may change DNA, leading to increased craving for alcohol
February 22, 2019 - U.S. opioid deaths jump fourfold in 20 years; epidemic shifts to Eastern states | News Center
February 22, 2019 - 5 Questions with William Turner on Diversity in Medicine
February 22, 2019 - HHS Finalizes Rule Seeking To Expel Planned Parenthood From Family Planning Program
February 22, 2019 - Researchers uncover biochemical pathway that may help identify drugs to treat Alzheimer’s
February 22, 2019 - Biologist uses new grant to find ways to eliminate schistosomiasis
February 22, 2019 - Bag-mask ventilation to help patients breathe during intubation prevents complications
February 22, 2019 - AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
February 22, 2019 - Nature versus nurture and addiction
February 22, 2019 - New website connects researchers with data experts, resources | News Center
February 22, 2019 - Today’s Concerns About Drug Prices Echo The Past
February 22, 2019 - CT and Doppler equipment have low accuracy in detecting cerebral vasospasm and ischemia
February 22, 2019 - Study finds out similarity in function between healthy retina cell and tumor cell
February 22, 2019 - CWRU awarded NIH grant to identify effective treatments for intimate partner violence
February 22, 2019 - Oncotype DX Not Cost-Effective for Low-Risk Breast Cancer
February 22, 2019 - Scientists discover new type of immune cells that are essential for forming heart valves
February 22, 2019 - Talk About Déjà Vu: Senators Set To Re-Enact Drug Price Hearing Of 60 Years Ago
February 22, 2019 - Genetic defect linked to pediatric liver disease identified
February 22, 2019 - New cellular atlas could provide a deeper insight into blinding diseases
February 22, 2019 - Growing number of cancer survivors, fewer providers point to challenge in meeting care needs
February 22, 2019 - Innovative compound offers a new therapeutic approach to treat multiple sclerosis
February 22, 2019 - $1.5 million grant to develop opioid treatment program for jail detainees
February 22, 2019 - FDA’s new proposed rule would update regulatory requirements for sunscreen products in the U.S
February 22, 2019 - Most Hip, Knee Replacements Last Decades, Study Finds
February 22, 2019 - Wellness problems prevalent among ob-gyn residents
February 22, 2019 - In the Spotlight: “The world is your oyster in geriatrics”
February 22, 2019 - Successful testing of multi-organ “human-on-a-chip” could replace animals as test subjects
February 22, 2019 - Analysis of cervical precancer shows decline in two strains of HPV
February 22, 2019 - Sugary stent eases suturing of blood vessels
February 22, 2019 - From surgery to psychiatry: A medical student reevaluates his motivations
February 22, 2019 - Is New App From Feds Your Answer To Navigating Medicare Coverage? Yes And No
February 22, 2019 - New pacemakers powered by heartbeats could reduce need for surgery
February 22, 2019 - The United States records highest drug overdose death rates
February 22, 2019 - Morning walks could be better than drugs at lowering blood pressure
February 22, 2019 - Phase 1 data reinforce safety profile of new drug for treating Duchenne muscular dystrophy
February 22, 2019 - Vitamin D supplementation less effective in the presence of obesity, shows study
February 22, 2019 - Novostia raises CHF 6.5 million to advance its aortic, mitral heart valve to clinical trials
February 22, 2019 - CPRIT awards nearly $20 million to The University of Texas MD Anderson Cancer Center
February 22, 2019 - Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
February 22, 2019 - An institutional effort to reduce the amount of opioids prescribed following lumbar surgery
February 22, 2019 - Family-history-based models perform better than non-family-history based models
February 22, 2019 - Failure to take statins leads to higher mortality rates | News Center
February 22, 2019 - New study explains why some patients report phantom sensations after limb amputation
February 22, 2019 - First motor-controlled heart valves implanted by Mainz University Medical Center
February 22, 2019 - Novel preclinical model mimics persistent interneuron loss seen in preterm infants
February 22, 2019 - Global health burden of glaucoma has increased, study reveals
February 22, 2019 - A holistic approach key to minimize treatment complexity in patients with interstitial lung disease
February 22, 2019 - 1 in 10 middle-aged Chinese adults are at high risk for heart disease, finds study
February 22, 2019 - More than half a million breast cancer patient’s lives saved by improvements in treatment
February 22, 2019 - Study finds no evidence that tougher policies prevent teenage cannabis use
February 22, 2019 - New blood test detects genetic disorders in fetuses
February 22, 2019 - Lower Self-Perception Observed in Children With Amblyopia
February 22, 2019 - Up to 15 percent of children have sleep apnea, yet 90 percent go undiagnosed
February 22, 2019 - Rare pulmonary defect prompts parents’ nationwide search for answers | News Center
February 22, 2019 - Lesbian and bisexual women at greater risk of being overweight, study finds
February 22, 2019 - UQ research may explain why vitamin D is essential for brain health
February 22, 2019 - Heart Attacks Rising Among Younger Women
February 22, 2019 - How your smartphone is affecting your relationship
February 22, 2019 - Orthopaedic surgeon receives prestigious award, $10 million grant | News Center
February 22, 2019 - New sepsis test could save thousands of lives
February 22, 2019 - Cervical cancer could be eradicated by 2100
February 21, 2019 - Sustained smoking cessation can lower risk of seropositive RA
February 21, 2019 - Thousands with chronic UTIs are not receiving the treatment they need
February 21, 2019 - Are teens getting high on social media? The surprising study seeking the pot-Instagram link
February 21, 2019 - Stanford expands biobank services | News Center
February 21, 2019 - Scientists identify link between drinking contexts and early onset intoxication among adolescents
February 21, 2019 - Strong social support may reduce cardiovascular disease risk in postmenopausal women
February 21, 2019 - Rapid expansion of interventions could prevent up to 13 million cases of cervical cancer within 50 years
February 21, 2019 - Motif Bio Receives Complete Response Letter From The FDA
February 21, 2019 - Researchers map previously unknown disease in children
T-CALM Phase 2 clinical study results offer hope for essential tremor patients

T-CALM Phase 2 clinical study results offer hope for essential tremor patients

image_pdfDownload PDFimage_print

Cavion, Inc., a leading clinical stage biotechnology company committed to developing novel therapeutics for people with neurological diseases, today announced promising results of the T-CALM Phase 2 clinical trial of its first-in-class T-type calcium channel modulator CX-8998 in essential tremor. The company plans to present results from this proof-of-concept study as a late-breaking poster on Monday, October 8 at the International Congress of Parkinson’s Disease and Movement Disorders® in Hong Kong.

Multiple secondary and exploratory endpoints collectively showed that treatment with CX-8998 10mg twice daily resulted in statistically significant improvement versus placebo in activities of daily living and patient-reported and clinical outcome measures, despite the study’s primary endpoint being missed. In the study, CX-8998 demonstrated a favorable safety and tolerability profile, with patients in the drug treatment arm reporting higher levels of satisfaction with tremor control medication compared to patients on placebo.

“After decades without new effective drug therapy options, we believe that the neurostabilizing effects of CX-8998 provide hope for essential tremor patients,” said Spyros Papapetropoulos, MD, PhD, Cavion’s Executive Vice President of Research & Development and Chief Medical Officer. “The data are particularly compelling given that about two-thirds of patients in the study were on standard of care treatment and significant improvement was achieved with CX-8998 on several measures in a study lasting just one month.”

“Essential tremor is a challenge to treat, and patients often do not respond favorably to the existing medications, many of which have been available for decades,” said Karl Kieburtz, MD, MPH, Professor of Neurology at the University of Rochester Medical Center. “Cavion’s CX-8998 has a novel mechanism of action that may provide substantive improvement, and it could be an important therapeutic contribution above and beyond what we currently have for essential tremor. I look forward to its clinical progress and further investigation. Better medications are needed to treat this common and disabling movement disorder.”

T-CALM was a 28-day, double-blind, placebo-controlled Phase 2 proof-of-concept clinical trial in 95 patients with moderate to severe essential tremor, conducted at 25 sites across the United States. Patients were randomized to receive either placebo or CX-8998 titrated up to 10mg dosed twice daily (BID). A majority of subjects (64 percent) added study drug to their existing standard of care anti-tremor medication.

The primary study endpoint using remote video rating of the Tremor Research Group Essential Tremor Rating Assessment Scale – Performance Subscale (TETRAS-PS), a measure of tremor severity, did not meet significance at Day 28 (p=0.696). In contrast, the same TETRAS-PS scale rated by the study investigators who observed the patients in person resulted in a significant improvement in tremor severity at Day 28 for the CX-8998 treated group compared to placebo (p=0.027). Independent analysis of the video rating process uncovered unexpected complications in implementation. Cavion is working closely with the scientific community to enhance central video rating for use in interventional studies.

Multiple secondary and exploratory endpoints collectively showed statistical significance, with benefits after 28 days of treatment in patients receiving CX-8998 10mg twice daily (BID) compared to placebo in the following scales:

  • The TETRAS Activities of Daily Living (TETRAS-ADL) scale, a measure of tremor impact on daily activities (p=0.049)
  • The Clinician Global Impression of Improvement (CGI-I), a measurement of physician-reported global improvement (p=0.001)
  • The TETRAS Total Score (TETRAS ADL + TETRAS-PS rated by the study Investigators, p=0.029)
  • The Goal Attainment Scale (GAS), a measure of progress toward patient-selected goals (such as dressing oneself, writing a sentence, or drinking out of a cup) (p=0.034)

In addition, the Patient Global Impression of Change (PGI-C), a measure of patient-reported improvement, trended towards significance favoring CX-8998 (p=0.089). Kinesia One, an algorithm-based digital measure developed for Parkinson’s disease, failed to detect a treatment difference in Essential Tremor patients. Additional analyses, including patient satisfaction with control by anti-tremor medication and traditional and digital spirography, support a treatment benefit with CX-8998. The drug showed a favorable safety and tolerability profile, with the majority of adverse events mild to moderate, transient and non-recurring. No major differences between CX-8998 and placebo were observed in laboratory values, vital signs or electrocardiography.

In addition to the T-CALM study for essential tremor, CX-8998 is currently being studied in T-WAVE, a multi-center Phase 2 clinical trial for generalized epilepsy with absence seizures. “The body of evidence supporting our ground-breaking approach is rapidly expanding,” said Andrew Krouse, President and CEO of Cavion. “Our pipeline of T-type calcium channel therapies extends beyond tremor to other neurological diseases that share a common pathophysiology. We look forward to initiating a Phase 3 study in tremor soon.”​

Source:

http://www.cavionpharma.com/

Tagged with:

About author

Related Articles