Two Studies Evaluate Monoclonal Antibody Tralokinumab For Asthma

MedicalResearch.com Interview with:

Reynold A. Panettieri, Jr., M.D. Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Clinical & Translational Science Director, Rutgers Institute for Translational Medicine & Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ  08901

Dr. Panettieri

Reynold A. Panettieri, Jr., M.D.
Professor of Medicine, Robert Wood Johnson Medical School
Vice Chancellor, Clinical & Translational Science
Director, Rutgers Institute for Translational Medicine & Science
Emeritus Professor of Medicine, University of Pennsylvania
Child Health Institute of New Jersey
Rutgers, The State University of New Jersey
New Brunswick, NJ  08901

MedicalResearch.com: What is the background for this study?

Response: Severe asthma is characterized by Type 2 inflammation manifested by increases in IL-13, IL-4 and Il-5 levels in the airways that promotes airway hyperresponsiveness and in part irreversible airway obstruction.  These clinical manifestations profoundly increase asthma morbidity and mortality.

To address an unmet therapeutic need, Tralokinumab was developed as a monoclonal antibody targeting soluble IL-13 with the goal of improving lung function and patient reported outcomes while decreasing annual exacerbation rates.  Stratus 1 and 2 represent two identical randomized, double-blind, placebo-controlled, phase 3 clinical trials in severe asthma.  These international trials enrolled approximately 2000 subjects with severe asthma and examined whether Tralokinumab decreased annualized exacerbation rates (AER) as compared with placebo (primary outcome).

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Dapagliflozin (Farxiga®)Added to Insulin for Type 1 Diabetes May Improve Glycemic Control

MedicalResearch.com Interview with:

Chantal Mathieu, MD, PhD Professor of Medicine Clinical and Experimental Endocrinology Catholic University of Leuven, Belgium

Dr. Mathieu

Chantal Mathieu, MD, PhD
Professor of Medicine
Clinical and Experimental Endocrinology
Catholic University of Leuven, Belgium

MedicalResearch.com: What is the background for this study?

Response: People with type 1 diabetes (T1D) are confronted often with the inability to achieve satisfactory glycemic control, being good HbA1c, but in particular stable glycemic control, avoiding hyperglycemic events, but also hypoglycemic events, despite novel insulins and novel technologies. Moreover, intensive insulin therapy is often associated with weight gain, leading to an increase in overweight and obesity also in people with T1D. All of these issues affect quality of life.

In the DEPICT 2 study we examined the impact of adding a selective SGLT2 inhibitor, dapagliflozin (two doses tested – 5 and 10mg) in a double blinded manner versus placebo to background insulin (MDI or CSII) in people with T1D reaching insufficient glycemic control (HbA1c 7.5-10.5%). Primary endpoint was lowering in HbA1c at 24 weeks and secondary endpoints included insulin dose reduction and weight reduction as well as a composite endpoint of having a HbA1c drop of >=0.5% without severe hypoglycemia. The study ran internationally, with about 1/3 of patients coming from North America, 1/3 from Europe and 1/5 from Asia (Japan).

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Does Preloading With a Nicotine Patch Help Smokers Quit?

MedicalResearch.com Interview with:
“Day 1 of nicotine patch, just stuffed my face with lunch at work and do NOT even want a cigarette” by David Bruce Jr. is licensed under CC BY 2.0Paul Aveyard
Professor of Behavioural Medicine
Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Oxford

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Tobacco addiction occurs because of repeated pairings of the act and sensation of smoking with binding of nicotine in the midbrain leading to release of dopamine in the nucleus accumbens. These repeated pairings create associative learning and, when brain nicotine concentrations fall, this produces a compulsion to keep using tobacco. In theory, blocking the actions of nicotine released while smoking ought to reverse this learning. One way to do this is to use a nicotine patch which provides a steady state high concentration of nicotine that desensitises the nicotinic receptors in the midbrain, making them unresponsive to nicotine from a smoked cigarette. This is the theory behind nicotine preloading.

The clinical trial evidence that preloading works is equivocal, with some trials suggesting a very large therapeutic effect and others no benefit at all. In the light of both the promise and the uncertainty, we aimed to complete the largest trial to date of nicotine preloading to examine its effectiveness, safety, and tolerability.

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Amgen Tests IL-Blocker To Treat Symptoms of Hidden Gluten Consumption in Celiac Disease

MedicalResearch.com Interview with:

Markku Mäki, MD, PhD Professor (emeritus) at the University of Tampere and Presently research director at the Tampere University Hospital Tampere, Finland

Prof. Mäki

Markku Mäki, MD, PhD
Professor (emeritus) at the University of Tampere and
Presently research director at the
Tampere University Hospital
Tampere, Finland

MedicalResearch.com: What is the background for this study?

Response: The only treatment for this life-long gluten-induced autoimmune systemic disease is a strict avoidance of wheat, rye and barley, the food cereals which contain gluten, the environmental trigger and driving force in celiac disease.  Gluten causes intestinal
inflammation, usually with (but sometimes without) gastrointestinal or
nutritional symptoms or signs, and with frequent extra-intestinal
diseases. However, it is impossible for celiac disease patients to
avoid gluten entirely and indefinitely and a third of patients report
symptoms on a strict gluten-free diet. Gut mucosal healing is not
optimal in half of the patients, and inflammation and injury is
detected for years after starting the diet, presumably due to
contamination with gluten in the diet. This is why patients are
requesting, and academia and industry are looking for novel adjunct
therapies for celiac disease. Initially, these therapies are tested to
prevent the consequences of hidden gluten; the ultimate goal being
that also celiacs could one day eat safely wheat, barley and rye
products. Some 20 novel experimental therapies are at present actively
being investigated (modifying wheat or different drugs, devices and
vaccines/immunotherapy).

The present study investigated whether blocking interleukin 15, an
important mediator of celiac disease, reduces or prevents
gluten-driven ill health, both the inflammation and injury at the
small intestinal mucosal level and gluten-induced symptoms. The
experimental drug used was Amgen’s AMG 714, a human monoclonal
antibody, used at a low and high dose, in the presence or absence of a
high-dose gluten challenge. Continue reading

What Surveillance Testing Should Be Done After Melanoma Diagnosis?

MedicalResearch.com Interview with:

This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.

This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.
CDC Image

Dr. Diwakar Davar, MD
Assistant Professor of Medicine
Division of Hematology/Oncology
University of Pittsburgh 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The optimal surveillance strategy to detect recurrence in cutaneous melanoma remains elusive. Risk of recurrence increases with higher stage, and is especially high for patients with stage IIIC disease. Although consensus guidelines agree on surveillance imaging for high-risk (stage IIB-IIIC) MEL, there is no consensus regarding optimal frequency/modality in these patients. NCCN guidelines suggest chest radiography (CXR) at 6- to 12-month intervals for stage IA-IIA melanoma  patients; although this is controversial. There exists a great deal of practice variation in the surveillance of these patients. Continue reading

Nintedanib (OFEV®) May Offer Survival Advantage for IPF Patients

MedicalResearch.com Interview with:

Christopher J. Ryerson, M.D. Assistant Professor Centre for Heart Lung Innovation University of British Columbia Vancouver, Canada

Dr. Ryerson

Christopher J. Ryerson, M.D.
Assistant Professor
Centre for Heart Lung Innovation
University of British Columbia
Vancouver, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A new Idiopathic pulmonary fibrosis (IPF) mortality analysis presented at the American Thoracic Society’s 2018 annual conference suggests that treatment with nintedanib may be associated with reduced risk of death in patients with the rare lung disease idiopathic pulmonary fibrosis (IPF).

Pooled data from the two Phase II INPULSIS trials and the Phase II TOMORROW study compared the number of deaths observed versus the number predicted based on GAP stage over one year. GAP stage is used to predict IPF prognosis and is based on gender, age and lung function (as measured by forced vital capacity [FVC] decline predicted and DLco % predicted). Higher stages of GAP are associated with an increased risk of death.

Across the population in the analysis (n=1,228), there were fewer deaths observed in each treatment group than predicted based on GAP stage at baseline (nintedanib: 42 vs. 89.9; placebo: 41 vs. 64.2). In the treated group, the number of observed deaths was 46.7% of the number predicted based on GAP stage, while in the placebo group the number of observed deaths was 63.9% of the number predicted. Based on these observations, the analysis suggests that nintedanib may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year.  Continue reading

Zosano Developing Dermal Patch to Quickly Relieve Migraine Pain

MedicalResearch.com Interview with:
Zosano Pharma
Dr. Peter Schmidt, MD, MSc

Senior Director, medical Affairs and Clinical Development
Zosano Pharma

 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This was a post-hoc analysis of Zosano’s pivotal efficacy trial using its adhesive dermally-applied microarray (ADAM) zolmitriptan formulation, M207. The trial found that M207 was effective versus placebo for the co-primary endpoints of pain freedom and most bothersome symptom (MBS) freedom, both at two hours. The MBS endpoint was just ratified as a new endpoint in the FDA’s February 2018 guidance for acute migraine trials. The stated aim of this new endpoint is “…to better align the study outcome with the symptom(s) of primary importance to patients…” This is logical, as a given migraine patient may not experience all four previous symptom endpoints (pain, photophobia, phonophobia, nausea). Continue reading

Combination Therapy Could Dramatically Alter CLL Treatment

MedicalResearch.com Interview with:

Dr. Danelle James,

Dr. James

Dr. Danelle James, M.D., M.A.S.
Head of Clinical Science
Pharmacyclics, an AbbVie Company

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: CAPTIVATE is a Phase 2 study investigating IMBRUVICA (ibrutinib) plus VENCLEXTA (venetoclax) for the treatment of Chronic Lymphocytic Leukemia (CLL) in the first-line setting. It was designed to evaluate if remission with undetectable minimal residual disease (MRD) can provide treatment-naïve CLL/SLL patients with treatment holidays (a period of time when a patient is able to stop therapy). The study enrolled 164 patients with previously untreated CLL or SLL.

In preclinical and ongoing clinical studies, we’ve seen complementary activities with this combination. The combination has also previously shown potential for deeper remissions, as well as potential for lower risk of tumor lysis syndrome with ibrutinib as the lead-in therapy.

Early data from CAPTIVATE show promising activity for the combination in this patient population, with 77 percent of the first 30 patients achieving responses with no detectable MRD in the blood after only six cycles of the combination therapy. Approximately nine out of 10 of the first patients achieved undetectable MRD after 12 cycles of combination therapy (which were preceded by three cycles of single agent ibrutinib, for a total of 15 cycles of therapy). Specifically, 86 percent of the first 14 patients achieved undetectable MRD in the marrow and 93 percent in the peripheral blood.

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Pressure To Produce Cheaper Generics Linked to More Hazardous Drug Recalls

MedicalResearch.com Interview with:
“pills” by Dominique Godbout is licensed under CC BY 2.0George P. Ball PhD
Operations and Decision Technologies Department
Kelley School of Business, Indiana University
Bloomington, IN 47405,

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We sought to examine how the intense pressure on firms to produce generic drugs more cheaply might influence product quality.

We find that the greater proportion of generic drugs a firm manufactures, the more severe product recalls they experience, because of an apparent relaxation of manufacturing quality standards. Additionally, they experience fewer less severe recalls, which may also result from forces of competition.

When the opportunity exists to not announce a recall that has high discretion, competition may lead firms to forgo the recall to avoid negative ramifications associated with recalls.

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Apalutamide (Erleada™) Extended Metastasis-Free Survival in Resistant Prostate Cancer

MedicalResearch.com Interview with:

Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM

Dr. Saad

Dr. Fred Saad, MD FRCS
Full Professor and Chief of Urologic Oncology, CHUM;
Medical Director of Interdisciplinary Urologic Oncology Group, CHUM;
Department of Surgery/Faculty of Medicine;
Institut du cancer de Montréal/CRCHUM

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The SPARTAN study was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluated ERLEADA (apalutamide), a next-generation androgen signaling inhibitor, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who had a rapidly rising PSA (PSA doubling time ≤10 months). The post-hoc analysis presented at the American Urological Association (AUA) 2018 annual meeting showed in patients who received the treatment apalutamide while receiving continuous androgen deprivation therapy (ADT) significantly decreased the risk of PSA progression by 94 percent compared with the placebo group. Continue reading

Lokelma Receives FDA Approval To Treat Elevated Potassium, Hyperkalemia

MedicalResearch.com Interview with:

Steven Fishbane, MD, Chief, Division of Kidney Disease and Hypertension, Northwell Health Vice President, Northwell Health for Network Dialysis Services, Northwell Health Professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Lead investigator of the ZS 005 study.

Dr. Fishbane

Steven Fishbane, MD,
Chief, Division of Kidney Disease and Hypertension, Northwell Health
Vice President, Northwell Health for Network Dialysis Services, Northwell Health
Professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Lead investigator of the ZS 005 study

MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by hyperkalemia?What are the dangers of an elevated potassium and how does LOKELMA differ from prior standard treatments?

 Response: Hyperkalemia is when the potassium in the blood rises to potentially harmful levels. High potassium is primarily harmful for the heart. As the potassium level rises the risk for abnormal electrical rhythms or disruption of the heart’s pumping occur. When severe, a high potassium level can cause death.

Lokelma has been demonstrated to be effective for lowering potassium levels with a great degree of consistency. It is well tolerated and has a fairly rapid onset of potassium lowering compared to other drugs for the purpose.  Continue reading

DARZALEX® (daratumumab) Approved for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible

MedicalResearch.com Interview with:

Andrzej Jakubowiak, MD, PhD Professor of Medicine Director, Myeloma Program University of Chicago

Dr. Jakubowiak


Andrzej Jakubowiak, MD, PhD
Professor of Medicine
Director, Myeloma Program
University of Chicago

MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by multiple myeloma?

 

Response: DARZALEX (daratumumab) in combination with VELCADE (bortezomib), melphalan and prednisone – VMP – received U.S. FDA approval for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). With this most recent approval, DARZALEX is now the first monoclonal antibody approved for newly diagnosed patients with this disease.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow. Despite the introduction of new medicines over the last decade, which has led to significant improvements in outcomes for patients with multiple myeloma, multiple myeloma remains an incurable disease. In 2018, it is estimated that 30,700 people will be diagnosed and 12,770 will die from the disease in the United States.

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Cannabidiol Reduced Drop Seizures in Severe Epilepsy Disorder

MedicalResearch.com Interview with:

https://www.gwpharm.com/epilepsy-patients-caregivers/patientsAnup Patel, M.D.
Section Chief of Neurology
Interim Division Chief of Neurology
Nationwide Children’s Hospital


MedicalResearch.com: What is the background for this study?

Response: The study evaluated kids and adults with an epilepsy syndrome (Lennox Gastaut Syndrome – LGS) that is often difficult to treat and does not respond well to current medical treatment.  The study was a double blind randomized control trial evaluating how well a plant based, liquid solution, cannabidiol (CBD) product made by Greenwich Biosciences called Epidiolex helped to treat drop seizures (the most common seizure type in LGS) and how safe it was compared to placebo.  Two doses (10 mg/kg/day and 20 mg/kg/day) were evaluated compared to placebo.

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More Opioids Prescribed By Doctors Who Received Free Pharmaceutical Lunches

MedicalResearch.com Interview with:
“Big Lunch Extras Reading” by Big Lunch Extras is licensed under CC BY 2.0Scott E. Hadland, MD, MPH, MS
Assistant Professor of Pediatrics | Boston University School of Medicine
Boston Medical Center
Director of Urban Health & Advocacy Track | Boston Combined Residency Program
Boston, MA 02118

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Numerous pharmaceutical companies have received media attention for their role in promoting opioid prescribing through speaker programs and other marketing plans in which large-value payments are given to a small number of doctors to promote opioids.

In our study, we sought to tell the other side of the story. We wanted to identify whether low-value marketing, including industry-sponsored meals, which are commonplace in the US, were associated with increased opioid prescribing.

We found that 1 in 14 doctors received opioid marketing from pharmaceutical companies in 2014, and those that received marketing prescribed 9% more opioids the following year. With each additional meal a doctor received, he or she prescribed more and more opioids the following year. Our sample included 43% of the active physician workforce in the US, suggesting how widespread and far-reaching this effect might be.

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Pneumonia Patients on Ventilators May Benefit from New Ceftolozane/Tazobactam Antibiotics

MedicalResearch.com Interview with:

Dr. Elizabeth Rhee MD Director, Infectious Disease Clinical Research at Merck

Dr. Rhee

Dr. Elizabeth Rhee MD
Director, Infectious Disease Clinical Research Merck

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: High-risk patients, such as the critically ill, with suspected bacterial infections require prompt treatment with appropriate empiric therapy to improve survival. Given the high prevalence of multidrug-resistant (MDR) Pseudomonas aeruginosa in the ICU setting, new safe and broadly effective treatment options are needed for critically ill patients requiring antipseudomonal agents.

Ceftolozane/tazobactam (C/T) is an antipseudomonal cephalosporin/beta-lactamase inhibitor combination with broad in vitro activity against Gram-negative pathogens, including MDR P. aeruginosa and many extended-spectrum beta-lactamase (ESBL) producers. It is FDA approved for complicated intra-abdominal and urinary tract infections in adults at 1.5g (1g/0.5g) q8h. C/T is currently being studied at 3g (2g/1g) q8h, for the treatment of ventilated nosocomial pneumonia, in the ASPECT-NP Phase 3 trial.

This Phase 1 pharmacokinetic (PK) study investigated the penetration of a 3g dose of C/T in the epithelial lining fluid (ELF) of ventilated patients with proven or suspected pneumonia. This is the dose and patient population being evaluated in ASPECT-NP. ELF lines the alveoli, and investigators took samples in a group of 26 patients to see what amount of C/T was in the lung and what was circulating in the plasma during the dosing intervals.

In mechanically ventilated critically ill patients, the 3g dose of C/T achieved ≥50% lung penetration (relative to free plasma) and sustained levels in ELF above the target concentrations for the entire dosing interval. These findings support the 3g dose that is included in the ASPECT-NP Phase 3 trial.  Continue reading

New Cephalosporin Combination Tested for Complicated Sepsis Patients

MedicalResearch.com Interview with:

Becky Jayakumar, PharmD College of Pharmacy Assistant Professor of Pharmacy Practice Roseman University of Health Sciences

Dr. Jayakumar

Becky Jayakumar, PharmD
College of Pharmacy
Assistant Professor of Pharmacy Practice
Roseman University of Health Sciences

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Bacteremia (bloodstream infections) due to Gram-negative (GN) bacteria are a frequent cause of severe sepsis and pose serious therapeutic challenges due to multidrug-resistance (MDR). Ceftolozane/tazobactam (C/T) is a novel antipseudomonal cephalosporin combined with an established β-lactamase inhibitor.

This retrospective, observational study evaluated the clinical outcomes of C/T real-world use in severely ill patients. Twenty-two patients with sepsis and/or bacteremia were included; 95% of whom had Pseudomonas aeruginosa that was resistant to almost all antibacterials with the exception of colistin. C/T successfully treated the majority of these complicated patients. In this real-world study, 77% of patients had a clinical response with C/T and 75% had a microbiological response. Clinical success rates were high and mortality rates were similar to other studies in this severely ill population. Continue reading

Merck Tests New Antibiotic Combination For Hard to Treat Bacterial Infections

MedicalResearch.com Interview with:

Amanda Paschke, MD, MSCE Senior principal scientist Infectious disease clinical research Merck Research Laboratories

Dr.Amanda  Paschke

Amanda Paschke, MD, MSCE
Senior principal scientist
Infectious disease clinical research
Merck Research Laboratories

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study sought to evaluate a new beta-lactam/beta-lactamase inhibitor antibacterial combination, imipenem/relebactam (IMI/REL), compared with colistin plus imipenem for the treatment of infections caused by resistant Gram-negative bacteria.

Patients enrolled in the trial had hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), complicated intra-abdominal infections (cIAI), or complicated urinary tract infections (cUTI) caused by pathogens that were non susceptible to imipenem, a carbapenem antibacterial.

In this study, the primary outcome was a favorable overall response to treatment, which was comparable between the IMI/REL vs colistin + IMI arms. Colistin (often combined with a carbapenem) is currently among the standard of care treatment regimens for MDR infections.  A key secondary endpoint of the study was safety.  IMI/REL was well tolerated; among all treated patients, drug-related adverse events (AEs) occurred in 16.1% of IMI/REL and 31.3% of colistin + IMI patients with treatment-emergent nephrotoxicity observed in 10% (3/29 patients) and 56% (9/16 patients), respectively (p=0.002). Results of the trial support the use of imipenem-relebactam (IMI/REL) as an efficacious and well-tolerated treatment option for carbapenem-resistant infections.  Continue reading

Alzheimer Study: New Drug Did Not Reduce Cognitive Decline

MedicalResearch.com Interview with:
Dr. Michael F. Egan MD

Merck & Co.
North Wales, PA 19454  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A leading theory of Alzheimer’s Disease is that it is caused by the buildup of amyloid plaques in the brain. Amyloid is composed of a sticky peptide called Abeta.  Abeta production can be blocked by Inhibiting an enzyme called BACE.  In animal models, BACE inhibtion prevent amyloid accumulation.  We aimed to see if a potent BACE inhibitor would slow clinical decline in Alzheimer’s Disease.

EPOCH was a Phase 2/3 randomized, placebo-controlled, parallel-group, double-blind study evaluating efficacy and safety of two oral doses of verubecestat an investigational BACE inhibitor, administered once-daily versus placebo in patients with mild-to-moderate AD currently using standard of care treatment. The primary efficacy outcomes of the study are the change from baseline in cognition (assessed using the Alzheimer’s Disease Assessment Scale Cognitive Subscale, or ADAS-Cog),  as well as the change from baseline in function (assessed using the Alzheimer’s Disease Cooperative Study – Activities of Daily Living, or ADCS-ADL)  after 78 weeks of treatment.

Following the recommendation of the external Data Monitoring Committee (eDMC), which assessed overall benefit/risk during  the trial,  the study was stopped early, as there was “virtually no chance of finding a positive clinical effect.”

Verubecestat did not reduce cognitive or functional decline in patients with mild-to moderate Alzheimer’s disease and was associated with treatment-related adverse events.  Continue reading

Does Drug Industry Money Affect Cancer Prescriptions?

MedicalResearch.com Interview with:

Aaron Mitchell, MD Division of Hematology/Oncology, Department of Medicine,  Lineberger Comprehensive Cancer Center The Cecil G. Sheps Center for Health Services Research The University of North Carolina at Chapel Hil

Dr. Mitchell

Aaron Mitchell, MD
Division of Hematology/Oncology, Department of Medicine,
Lineberger Comprehensive Cancer Center
The Cecil G. Sheps Center for Health Services Research
The University of North Carolina at Chapel Hill

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Financial relationships between physicians and the pharmaceutical industry are very common. However, we are just beginning to figure out whether these relationships may lead to potentially concerning changes in physician behavior – whether physicians tend to prescribe more of the drugs made by a company that has given them money. We decided to ask whether oncologists who receive money from drugmakers are more likely to use the cancer drugs made by companies that have given them money in the past.

In studying two specific groups of cancer drugs, one for kidney cancer and one for chronic myeloid leukemia (CML), we found that oncologists who had received payments such as meals, consulting fees, travel & lodging expenses from the manufacturer of one of these drugs tended to use that drug more. When looking at oncologists who received payments for research, we found increased prescribing among the kidney cancer drugs but not the CML drugs.

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Phase 3 Trial of Cariprazine (Vraylar) Shows Promise in Bipolar Depression

MedicalResearch.com Interview with:

Dr. C. David Nicholson, PhD Chief R&D Officer  Allergan

Dr. C. David Nicholson

Dr. C. David Nicholson, PhD
Chief R&D Officer
Allergan

MedicalResearch.com: What is the background for this data milestone? 

Response: Bipolar I depression refers to the depressive episodes of bipolar I disorder, the overarching brain and behavioral disorder. People with bipolar I disorder can have manic and depressive episodes, as well as mixed episodes that feature both manic and depressive symptoms at the same time. Bipolar I depression typically lasts at least two weeks, and can be difficult to differentiate from major depression during diagnosis.

Once diagnosed, treating bipolar depression can be difficult given the few therapies available to manage these symptoms of bipolar I disorder. Additionally, patients with bipolar disorder may experience shifts from depression to mania or mania to depression as well as mixed states. More treatment options are needed so that physicians can find a therapy that will treat bipolar depression effectively, while also addressing the myriad of other symptoms that patients can experience.

Cariprazine is already approved for the treatment of mania and mixed episodes. With this new data, we have the potential to also treat bipolar depression, effectively addressing the full spectrum of symptoms associated with bipolar I disorder with just one medication.

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