AACR, Author Interviews, Biomarkers, Breast Cancer, Cancer Research / 11.04.2024

MedicalResearch.com Interview with: RJ Tesi M.D. CEO and Founder of INmune Bio MedicalResearch.com: What is the background for this study? What are the main findings?
  • MUC4 expression by high-risk breast cancer (HER2+ or TNBC) is a biomarker that predicts resistance to therapy and an increased risk a metastasis. MUC4 expression can be determined at time of biopsy and therapeutic decisions should be adjusted to optimize the chance of response to first line therapy.
This biomarker is easily determined using immunohistochemistry in the diagnostic breast biopsy tissue similar to testing for HER2 expression. Testing for MUC4 can be easily added to the current panel of routine stains obtained at the time of the diagnostic biopsy. Knowing MUC4 status in women with high-risk breast cancer will improve results.
  • Soluble TNF causes the up regulation of immune checkpoint proteins of cells of the TME. This includes CD47 and SIRPa on tumor based macrophages and CTLA4, PD1, LAG3 and TIGIT on T cells in the TME. INB03 is a pan immune checkpoint modulator. Treatment with INB03 downregulates all immune checkpoint proteins on the cells. Downmodulation of all immune checkpoint proteins improves response to immunotherapy.
Currently, monoclonal antibodies targeting immune checkpoint proteins are a mainstay of cancer therapy and cancer drug development. These strategies target one immune checkpoint protein at a time. To date, combination therapy targeting two immune checkpoint proteins has been tried (e.g.: anti-PD1 and anti-CTLA4 combination therapy) with mixed results. Combination immune checkpoint strategies may increase therapeutic response but increase toxicity. INB03 downregulates all immune checkpoint proteins. This is equivalent to giving a patient a 6 antibody cocktail – something that cannot be done in man. As expected, decreased immune checkpoint expression improves response to therapy by converting immunotherapy resistant tumors to immunotherapy sensitive tumors.
  • In TNBC, MUC4 expression predicts both resistance to anti-PD1 therapy and increased risk of distant metastasis. Treatment with INB03 decreases expression of proteins associated with tumor metastasis, decreases the number of metastasis and improves response to anti-PD1 therapy. Early use of INB03 may prevent distal disease and improve tumor control.
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Aging, Author Interviews, Mental Health Research, Sleep Disorders / 02.07.2023

MedicalResearch.com Interview with: Valentina Paz, M.Sc Ph.D.  Student Research and teaching assistant Universidad de la República, UruguayHon. Research AssistantMRC Unit for Lifelong Health & Ageing Department of Population Science & Experimental MedicineInstitute of Cardiovascular ScienceUniversity College London MedicalResearch.com: What is the background for this study? Response: Prior research indicates that napping can enhance performance on specific cognitive tasks. However, some authors argue that the advantages derived from napping may vary between individuals who frequently have a nap and those who never naps. Furthermore, it remains to be seen whether habitual daytime napping has a positive or negative impact on cognition and the association between napping and brain volume is not well characterized. Therefore, our study aimed to examine whether the association between genetic liability to daytime napping, cognitive function, and brain volumes might be causal using a technic called Mendelian randomization and the UK Biobank. (more…)
Author Interviews, Blood Pressure - Hypertension, Personalized Medicine / 11.04.2023

MedicalResearch.com Interview with: Johan Sundström, MD, PhD Professor of Epidemiology at Uppsala University Professorial Fellow at The George Institute for Global Health Cardiologist at Uppsala University Hospital MedicalResearch.com: What is the background for this study? Response: High blood pressure, hypertension, is a growing global health challenge. Over the last 30 years, the number of people with hypertension has doubled, and it is estimated that around a third of adults aged 30-79 have the condition - a total of 1.28 billion people worldwide. Untreated hypertension can lead to kidney disease, heart disease, and stroke, accounting for 11.3 million deaths in 2021 alone. A small minority get their blood pressure under control with drug therapy, and some studies indicate that as little as half are taking their blood pressure medications as intended. Is this because the drugs' effectiveness and side effects differ between different individuals? If so, there would be a substantial risk that patients will not get their optimal medication on the first try, with poor blood pressure lowering and unnecessary side effects as a result. In a new clinical trial in Sweden, it was studied whether there is an optimal blood pressure medication for each person, and thus a potential for personalized blood pressure treatment. In the study, 280 people with high blood pressure tried out four different blood pressure drugs on several different occasions over a total of one year. (more…)
Author Interviews, Diabetes, Karolinski Institute, Pediatrics, Weight Research / 28.02.2023

MedicalResearch.com Interview with: Yuxia Wei | PhD Student Unit of Epidemiology Institute of Environmental Medicine Karolinska Institutet Stockholm | Sweden   MedicalResearch.com: What is the background for this study? Response: Diabetes is traditionally known for having two types (type 1 diabetes and type 2 diabetes). However, it is becoming increasingly clear that diabetes is much more complex than this traditional classification. Several attempts have been made to address this heterogeneity and in 2018, a  Swedish ground-breaking study proposed that there are five distinct subtypes of diabetes in adults. They have been replicated in different populations and it has been shown that there are differences between the subtypes in terms of genetics and risks of complications. Another way of elucidating the relevance of these subtypes is to investigate whether the influence of known risk factors for diabetes is different on different subtypes. Our study is one of the first attempts to address this. We used a study design known as Mendelian randomization, to investigate the influence of childhood obesity on these diabetes subtypes that typically occur after age 35. This work was a collaboration between Karolinska institutet in Stockholm, University of Bristol in the UK and Sun Yat-Sen University in China. (more…)
Author Interviews, Diabetes, NEJM, OBGYNE / 19.08.2022

MedicalResearch.com Interview with: Professor Caroline Crowther MB ChB, DCH, FRANZCOG, MD, DDU, FRCOG, CMFM Maternal Fetal Medicine Subspecialist Professor of Maternal & Perinatal Health Liggins Institue Waipapa Taumata Rau | University of Auckland MwdicalResearch.com: What is the background for this study? Response: Gestational diabetes is a growing and significant health problem worldwide for women affected and their babies. Treatment of gestational diabetes improves maternal and infant health but it remains unclear what degree of maternal hyperglycaemia should be used to make the diagnosis. Because of this uncertainty, recommended diagnostic criteria vary around the world. The GEMS randomised trial assessed whether use of lower glycaemic diagnostic criteria, recommended by the International Association of Diabetes and Pregnancy Study Groups would improve perinatal health, without increasing maternal risks, compared to use of higher criteria, and to assess the effects on use of the health services. (more…)
Author Interviews, Cancer Research, Nutrition / 26.07.2022

MedicalResearch.com Interview with: Prof. John C. Mathers PhD Director, Human Nutrition Research Centre Director, Centre for Healthier Lives Population Health Sciences Institute Newcastle University Newcastle on Tyne UK MedicalResearch.com:  What is the background for this study?   Response: My colleagues and I have had a long-term interest in carrying out studies in people with hereditary cancer as a model for cancer in the general population. Here we studied people with Lynch syndrome who have an inherited defect in one of the genes encoding the DNA mismatch repair system. Because of this, they accumulate DNA damage faster than the general population and are prone to early cancers at several sites around the body. In the CAPP2 Study, we randomised almost 1000 people with Lynch syndrome to either resistant starch or to an ordinary corn-starch placebo. (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 07.06.2022

MedicalResearch.com Interview with: HoJin Shin, BPharm, PhD Postdoctoral Research Fellow Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston, Massachusetts MedicalResearch.com:  What is the background for this study?  Response: The public health burden of cardiovascular disease has been increasing in people with diabetes along with the burden of diabetes itself.
  •  Cardiovascular disease affects approximately one-third of the population with type 2 diabetes and accounts for     50%–80% of their mortality
  • 1 in 10 people in the US has diabetes
Since 2008, the US FDA has recommended post-approval cardiovascular outcome trials to ensure the safety of new glucose-lowering drugs responding to this growing burden of cardiovascular disease in type 2 diabetes and the potential increase in cardiovascular risk with certain existing glucose-lowering drugs (e.g., rosiglitazone). Notably, SGLT-2i have demonstrated superiority to placebo in reducing the risk of cardiovascular events, including hospitalization for heart failure. Consequently, beginning in 2018, clinical guidelines in the US have recommended SGLT-2i as a preferred second-line treatment for patients with type 2 diabetes and cardiovascular disease. As the paradigm of second-line pharmacological treatment for type 2 diabetes has shifted to include the management of cardiovascular risk in addition to glycemic control, this further raised the question of whether SGLT-2i should be advanced to first-line treatment. Since 2019, SGLT-2i have been recommended as a first-line agent for patients with type 2 diabetes and cardiovascular disease by the European guidelines (the European Society of Cardiology and the European Association for the Study of Diabetes). In the absence of head-to-head RCTs, non-randomized studies using real-world data could provide information on whether SGLT-2i may have greater cardiovascular benefits over metformin more timely than randomized clinical trials among both patients with and without existing CVD. Therefore, we evaluated the risk for cardiovascular events among adults with T2D who initiated treatment with first-line SGLT-2i versus metformin in clinical practice. (more…)
Author Interviews, Brigham & Women's - Harvard, Fertility, Heart Disease, JACC / 19.04.2022

MedicalResearch.com Interview with: Emily Lau, MD, MPH Cardiologist Instructor in Medicine, Harvard Medical School Director, Menopause, Hormones & Cardiovascular Disease Clinic Massachusetts General Hospital MedicalResearch.com:  What is the background for this study?  What are the main findings? Response: Emerging data suggest that a woman’s reproductive history influences her future risk of heart disease. Infertility is a reproductive risk factor that affects ~14% of women but has not been rigorously studied with respect to its relationship with cardiovascular disease risk. We studied over 38,000 women enrolled in the Women’s Health Initiative and found that infertility was associated with greater risk of heart failure. In particular, we found that the association was driven by greater risk of heart failure with preserved ejection fraction, a form of heart failure that is far more common among women. (more…)
Author Interviews, Endocrinology, Nutrition, Testosterone, Weight Research / 11.03.2022

MedicalResearch.com Interview with: Joe Whittaker, MSc Nutritionist MedicalResearch.com:  What is the background for this study?  Response: There are several studies showing a generational decline in men's testosterone levels, beginning in the 1970s. This is due to a variety of factors such as poorer diets, lack of physical activity, and increasing toxin exposure. Therefore, there is intense research interest in ways we can optimise testosterone levels, to combat this generational decline. Some well-known studies have found low-carbohydrate diets boost testosterone levels, but others have show the reverse effect. So, to settle the controversy we gathered and reanalysed all known studies on the topic. There was also the question of high protein diets and their effects on testosterone, which are currently disputed. (more…)
ADHD, Author Interviews, Cost of Health Care, Eating Disorders, Pharmacology / 09.01.2022

MedicalResearch.com Interview with: Sneha Vaddadi, BS Department of Medical Education Geisinger Commonwealth School of Medicine Scranton, Pennsylvania MedicalResearch.com: What is the background for this study? Response: The prescription stimulants methylphenidate, amphetamine, and lisdexamfetamine, classified as Schedule II substances, are sympathomimetic drugs with therapeutic use widely used in the US for Attention Deficit Hyperactivity Disorder. Changes in criteria for diagnosis of Attention Deficit Hyperactivity Disorder in 2013 and approval of lisdexamfetamine for binge eating disorder in 2015 may have impacted usage patterns. The goal of this study1 was to extend upon past research2 to compare the pharmacoepidemiology of these stimulants in the United States from 2010–2017, including consideration to variation within geographic regions, the Hispanic population, and the Medicaid population. (more…)
Alzheimer's - Dementia, Author Interviews, Clots - Coagulation, Heart Disease / 23.11.2021

MedicalResearch.com Interview with: Bruno Caramelli MD PhD Associate Professor of Medicine University of Sao Paulo, Brasil Director, Interdisciplinary Medicine in Cardiology Unit Chairman of the PhD program in Medical Sciences at the University of Sao Paulo, Brazil. President of the Department of Clinical Cardiology at the Brazilian Society of Cardiology FESC: Fellow of the European Society of Cardiology MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation is the most common cardiac arrhythmia in older adults, and it is associated with an increased risk of stroke, cognitive impairment, and dementia. Stroke can occur when a blood clot blocks blood flow to the brain, and oral anticoagulants, such as dabigatran and warfarin, are typically prescribed to prevent stroke. Dabigatran has been found to be comparable to warfarin for the prevention of stroke and also has a lower risk of major bleeding complications. Previous research has shown that people with atrial fibrillation taking oral anticoagulation therapy have a lower risk of dementia, however, the mechanism involved in this benefit is unknown, and previous clinical trials have not evaluated cognitive and functional impairment outcomes among patients. It’s possible that cognitive decline is related to the formation of small blood clots in the brain, which is treated by effective medications that prevent blood clots. Since dabigatran offers a more stable anticoagulation status, we investigated whether it would be more effective than warfarin for the prevention of cognitive decline in patients with atrial fibrillation. Previous studies were retrospective and observational studies and considered tests that evaluate global cognitive function in a generic, global, and non-specific way. In that way its not possible to exclude different causes of dementia as Alzheimer's disease and others making it difficult to establish an effect directly related to atrial fibrillation or the anticoagulation treatment. (more…)
Author Interviews, Coffee, Heart Disease, JAMA, OBGYNE / 09.11.2021

MedicalResearch.com Interview with: Stefanie N. Hinkle, PhD Assistant Professor Department of Biostatistics Epidemiology and Informatics Perelman School of Medicine University of Pennsylvania MedicalResearch.com: What is the background for this study? Response: Over 80% of U.S. women of reproductive age consume caffeine daily.While most women decrease consumption after becoming pregnant, many continue to consume caffeine throughout pregnancy. The American College of Obstetricians and Gynecologists (ACOG) recommends that pregnant women limit their caffeine consumption to <200 mg/d out of an abundance of caution due to potential associations with pregnancy loss and fetal growth restriction at higher intakes. There remains limited data on associations with maternal cardiometabolic outcomes in pregnancy.   (more…)
Author Interviews, Brigham & Women's - Harvard, Medical Imaging, Neurological Disorders / 02.07.2021

MedicalResearch.com Interview with: Michael Ferguson, PhD Instructor in Neurology | Harvard Medical School Lecturer on Neurospirituality | Harvard Divinity School Center for Brain Circuit Therapeutics Brigham and Women’s Hospital MedicalResearch.com: What is the background for this study? Response: Over 80% of the global population consider themselves religious with even more identifying as spiritual, but the neural substrates of spirituality and religiosity remain unresolved. MedicalResearch.com: What are the main findings? Where is this circuit located in the brain? What other effects does this circuit control or influence? Response: We found that brain lesions associated with self-reported spirituality map to a human brain circuit centered on the periaqueductal grey. (more…)
Author Interviews / 29.06.2021

MedicalResearch.com Interview with: Scott Gray: Founder and CEO of Clincierge, the global leader in patient support services for clinical trials. With a team of patient coordinators around the world, Clincierge helps patients and their caregivers navigate the logistics of clinical trial participation, including prepaid air travel, ground transportation, and lodging as well as rapid reimbursements, translation and interpretation services, and individual solutions for trial participants in remote locations or with complex medical needs. For more information, visit clincierge.com. MedicalResearch.com: What is the mission of Clincierge? ClinciergeResponse: Our mission is to improve the performance of clinical trials around the world by better managing the patient experience through highly personalized patient support services and efficient processes carried out by a team of experienced travel and logistics professionals. (more…)