Charlottesville, Virginia. June 9, 2020. AMPEL BioSolutions announces genomic analysis and findings that could improve treatment of COVID19 patients with approved drugs such as Embrel and Stelara. Published on bioRxiv as a preprint, the study reveals a gene-based test that will be able to determine those patients who may progress to severe illness with increased likelihood of morbidity. In addition, AMPEL’s CovGENE approach identifies FDA-approved drugs that may be appropriately repositioned to interfere with mechanisms that cause lung damage in severe COVID19 patients. The paper describes gene expression measured in three body compartments (lung, airway and blood) and integrates information from the blood and lung for a “whole body” understanding of the effects of SARS-CoV2 virus.
Machine Learning, After Fine-tuning, May Be Useful for SLE Classification, Study Suggests
Lupus News Today
By Marisa Wexler, MS
July 12, 2019
Machine learning analysis strategies can help predict disease status in people with systemic lupus erythematosus (SLE), a study shows. Still, technical variability inherent to each clinical analysis method can represent a roadblock in this process.
Fine-tuning of machine learning algorithms and parameter sets may help reduced technical “noise” caused by such variability, the researchers suggest. They said this would generate “sufficient accuracy to be informative as a standalone estimate of disease activity.”
Titled “Machine learning approaches to predict lupus disease activity from gene expression data,” the study was published in Nature Scientific Reports.
Diagnosing and classifying SLE is a challenge for clinicians because the disease is so varied in how it presents. One proposed way to classify this type of lupus is based on gene expression levels, which evaluate which genes are “turned on” and by how much.
SAN FRANCISCO, Jan. 17, 2020 /PRNewswire/ — AMPEL BioSolutions’ Co-Founder and COO/CSO Dr. Amrie Grammer today at the Biotech Showcase at JP Morgan Healthcare announces the kickoff to commercialize LuGENETM, a gene-based diagnostic. AMPEL’s initial focus is Lupus, but the test can be used for many autoimmune or inflammatory diseases. AMPEL’S goal is to have its test available for routine use by physicians within the next few years.
LuGENETM is a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat chronic diseases, like Lupus. The lab test, only a concept for the last few years, is now ready for commercialization for practical decision support for precise drug treatment based on a patient’s genes. LuGENETM will transform the way doctors treat chronic diseases by using the information gathered by the lab test and analyzed by machine learning to predict a flare and treat it before it even begins, saving patients from pain and inconvenience of a disease that otherwise drastically affects their lives.
“Predicting lupus disease flares, allowing initiation or modification of disease-modifying therapies, should have an important impact on patient health,” stated Mary K. Crow, MD the Physician-in-Chief, Hospital for Special Surgery, Weill Cornell Medical Center and Former President American College of Rheumatology. “LuGENE seems to be an important step in that direction. Application of knowledge of molecular mechanisms to aid in patient management is the future of lupus care and will benefit patients and improve outcomes.”
AMPEL’s innovative gene-based approach has been reported in top tier peer-reviewed journals and utilizes proprietary bioinformatic tools and machine learning approaches. LuGENETM is now ready to be developed as a decision support CLIA-certified blood test that will greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment precisely.
“Unpredictable flares can be a daily battle for many patients with lupus and other autoimmune conditions,” says Deidre Baptista and Kirsten Maeda, “GEE Twins for Lupus”, Lupus Foundation of Northern California (LFNC) Board Members. “From personal experience, we know flares come and go without warning and make it challenging for patients. AMPEL’s promising breakthrough of their LuGENETM diagnostic is the news patients have desperately been waiting to hear. We applaud AMPEL BioSolutions’s goal to help identify patients’ disease activity in real time. The future of precision personalized medicine is getting closer with big data, technology, and genomic testing. It will certainly be a win-win not only for the patients but also the autoimmunity community. It’s about time that advances will improve patient outcomes, reduce organ damage and save lives. Patients can’t wait another 60 years for new treatment.”
Currently, AMPEL uses its’ proprietary approach to assist Pharma in patient enrichment during clinical trial enrollment, thus maximizing success by enrolling patients into trials that express the drug-targeted pathway. Pharmaceutical companies test drugs in clinical trials and face the challenge of enrolling patients that have the best potential to respond to the treatment being tested. Enrolling the “wrong” patients can result in trial failure, often leading to cancellation of a drug’s development towards FDA approval that may have benefit in a sub-group of the overall patient population. AMPEL’s blood test will help pharmaceutical companies identify which patients are most likely to respond to the tested treatment.
“Lupus care will greatly benefit from more precise evaluation of patients. LuGENE seems to be an important step in that direction. Patients would greatly benefit from a better way to relate their symptoms to immune abnormalities.” Daniel J Wallace MD FACP, MACR, Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA in affiliation with AttuneHealth.
To view the full presentation from the Biotech Showcase, click here.
To view the full press release, click here.
To watch the interview with Dr. Amrie Grammer, click here.
Multiple Interferons, Including IFNB1, May Play a Role in SLE
The Rheumatologist article by Carina Stanton (August 14, 2019)
Through gene analysis, researchers have found different types of interferons in systemic lupus erythematosus (SLE) tissues and cells, such as skin and synovium. The analysis, which probed 2,000 gene expression datasets from SLE patients, specifically investigated modules of genes derived from the downstream interferon gene signature. It found enriched downstream interferon signatures that were predominately from IFNB1. These interferon signatures were higher when compared with the expression of downstream interferon signatures in kidneys with lupus nephritis, according to the study, published April 23 in Nature Communications Biology.1
Read more here: https://www.the-rheumatologist.org/article/multiple-interferons-including-ifnb1-may-play-a-role-in-sle/
VALUE Study Results Show Custom Mobile App Lets Patients Accurately Report Response to Treatment
SOURCE Lupus Research Alliance
Data Presented at EULAR 2019
MADRID, June 13, 2019 /PRNewswire/ — Results of the first clinical trial sponsored by the Lupus Research Alliance (LRA) and conducted through its Lupus Clinical Investigators Network (LuCIN) were presented today at the European Congress of Rheumatology (EULAR) 2019. Entitled VAlidation in LUpus of an Electronic Patient Reported Outcomes Tool (VALUE), the study showed that a custom smartphone app effectively enabled lupus patients to report on their health-related quality of life, fatigue and other symptoms in real time rather than completing surveys during periodic visits to physicians’ offices.
The app was designed with input from people with lupus to capture Patient Reported Outcomes (PROs).
“Patient Reported Outcomes can provide important data about the impact of a disease on an individual patient and/or their response to medication,” noted principal investigator Peter Lipsky, MD, co-founder of AMPEL BioSolutions. “However, usually patients report their responses to treatment at a monthly visit and since it can be difficult to remember how they felt over several weeks, the information is not always accurate.”
The VALUE study showed that patients were well able to record their PROs using the mobile app daily and weekly. The frequency of the information reported with the app surpassed that collected when patients filled out standard paper forms at their monthly visits.
Researchers concluded that the app “affords the opportunity to acquire frequent and highly reliable information about the impact of disease and response to medication in individual patients with SLE.”
Pfizer Inc., the Lupus Research Alliance, AMPEL BioSolutions and Tata Consultancy Services Ltd. jointly developed the new mobile app, using the Apple ResearchKit platform and building on well-accepted research tools that have been validated in lupus. LRA hopes to utilize the electronic app in future drug trials to effectively report patient outcomes in real time.
“The burden of living with autoimmune and inflammatory diseases is often significant for patients because these diseases are so complex,” said Michael Vincent, Senior Vice President and Chief Scientific Officer of Pfizer’s Inflammation and Immunology Research Unit. “Our collaboration with the LRA, AMPEL, and Tata is helping us to quantify the many factors that affect patients in day-to-day life. These results complement our understanding of the complex biology of autoimmune diseases and may be key in helping us bring meaningful treatments to patients.”
The VALUE trial was carried out by investigators in the Lupus Clinical Investigators Network (LuCIN), a clinical trials network made up of many of the most prestigious medical research centers and experienced lupus physician-scientists throughout North America. Administered by the affiliate of the Lupus Research Alliance called Lupus Therapeutics, LuCIN provides a framework to quickly and cost-effectively test potential new therapies, as well as methods to diagnose and monitor response to treatment.
“We are very excited to see these results from the first clinical trial conducted through LuCIN,” commented Albert Roy, Executive Director of Lupus Therapeutics. “Using the immediacy of an electronic app promises to help patients more accurately report their symptoms and how they respond to treatment.”
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latinx, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
About the Lupus Research Alliance
The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization’s stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance’s Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.