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Expert Opinion on Biological Therapy

Hidehito Horinouchi
The mutation or expression of HER family members serves as a therapeutic target for tyrosine kinase inhibitors or monoclonal antibodies in diverse cancers, such as non-small cell lung cancer, breast cancer, gastric cancer, head and neck cancer, colorectal cancer, pancreatic cancer and glioblastoma. HER3, which heterodimerizes with HER1 and HER2, has received much attention as a potential target for anti-EGFR treatment. Patritumab is a novel, fully human monoclonal antibody directed against HER3. Areas covered: In this review article, an overview of the market, chemistry, pharmacodynamics, pharmacokinetics, efficacy, and safety of patritumab is provided based on data from phase I studies, a combination phase I trial, and a randomized phase II trial comparing two doses of patritumab...
October 17, 2016: Expert Opinion on Biological Therapy
Igor Slivac, David Guay, Mathias Mangion, Juliette Champeil, Bruno Gaillet
Delivery of nucleic acid-based molecules in human cells is a highly studied approach for the treatment of several disorders including monogenic diseases and cancers. Non-viral vectors for DNA and RNA transfer, although in general less efficient than virus-based systems, are particularly well adapted mostly due to the absence of biosafety concerns. Non-viral methods could be classified in two main groups: physical and vector-assisted delivery systems. Both groups comprise several different methods, none of them universally applicable...
October 14, 2016: Expert Opinion on Biological Therapy
Simon M Bell, Basil Sharrack, John A Snowden
Autologous haematopoietic cell transplantation (AHCT) is an evolving treatment avenue in multiple sclerosis (MS), which may be highly effective in controlling disease activity and improving disability. However, AHCT is associated with intrinsic toxicities and risks compared with conventional therapies. With growing experience in patient selection and treatment delivery, AHCT is increasingly considered an option in patients with aggressive disease that's responding poorly to disease modifying therapy. Areas covered: This article provides an introduction to AHCT and looks at its development as a treatment for MS over the last 20 years...
October 14, 2016: Expert Opinion on Biological Therapy
Koji Takeda, Haruko Daga
On December 12, 2014, the U.S. Food and Drug Administration (FDA) approved ramucirumab for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Areas covered: This review discusses the best treatment strategy for ramucirumab, a vascular endothelial growth factor receptor-2 inhibitor for patients with advanced NSCLC. Expert opinion: The addition of ramucirumab to docetaxel in the treatment of patients with metastatic NSCLC who have progressed on or after platinum-based chemotherapy confers a 1...
October 13, 2016: Expert Opinion on Biological Therapy
Surinder K Sharma, Kenneth D Bagshawe
The generation of cytotoxic drugs, selectively within tumours, from non-toxic prodrugs by targeted enzymes provides a powerful system for cancer therapy. In the form of Antibody directed enzyme prodrug therapy (ADEPT), this approach has shown feasibility in the clinic. Areas covered: Although numerous enzyme prodrug combinations have been reported over the last two decades, only the CPG2 ADEPT system has progressed to clinical trials. Using readily available components such as chemical antibody enzyme conjugate or recombinant multifunctional fusion protein, delivery of a specific enzyme to tumours, its elimination from non-tumour sites and prodrug activation has been achieved with therapeutic benefit in the clinic...
October 13, 2016: Expert Opinion on Biological Therapy
Marc S Rendell
Albiglutide is a long acting GLP-1 receptor agonist (GLP-1 RA) administered by weekly injection. Area covered: The pharmacokinetic and pharmacodynamic properties of albiglutide and its clinical effects are discussed. The review encompassed a search of PubMed and a thorough analysis of the European Union and US Food and Drug Administration approval documents. Expert opinion: Albiglutide has a chemical structure quite distinct from that of other marketed GLP-1 RAs. The agent has less gastrointestinal side effects than other comparable GLP-1 RAs and is safe in patients with renal failure...
October 3, 2016: Expert Opinion on Biological Therapy
Freddy Faccin, Paul Tebbey, Emily Alexander, Xin Wang, Lu Cui, Teotonio Albuquerque
INTRODUCTION: Loss of exclusivity for biological therapeutics opens the door for biosimilar development. Biosimilars must demonstrate structural, functional, and clinical similarity with a currently approved biological originator product. A therapeutic alternative for biologic-naive patients, a single switch from an originator to biosimilar has also been studied in clinically stable patients; further, switching therapy multiple times (alternating) between an originator and a biosimilar has been investigated...
September 27, 2016: Expert Opinion on Biological Therapy
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No abstract text is available yet for this article.
September 22, 2016: Expert Opinion on Biological Therapy
Cesare Gridelli, Paolo A Ascierto, Massimo C P Barberis, Enriqueta Felip, Edward B Garon, Mary O'brien, Suresh Senan, Francesca Casaluce, Assunta Sgambato, Vali Papadimitrakopoulou, Filippo De Marinis
INTRODUCTION: The potential long term survival gain, related to immune adaptability and memory, the potential activity across multiple tumour types through targeting the immune system, and the opportunity for combinations offered by the unique mechanism of actions and safety profile of these new agents, all support the role of immunotherapy in the cancer treatment pathway or paradigm. AREAS COVERED: The authors discuss the recent advances in the understanding of immunology and antitumor immune responses that have led to the development of new immunotherapies, including monoclonal antibodies that inhibit immune checkpoint pathways, such as Programmed Death-1 (PD-1) and Cytotoxic T-Lymphocyte-Associated Antigen 4 (CTLA-4)...
September 21, 2016: Expert Opinion on Biological Therapy
Carrie Luu, Nikhil I Khushalani, Jonathan S Zager
INTRODUCTION: Immunotherapy has revolutionized the treatment of metastatic melanoma and dramatically improved patient outcomes. Ipilimumab, an inhibitor of cytotoxic T-lymphocyte antigen-4 (CTLA-4), was the first immunotherapeutic agent to demonstrate improved survival in advanced melanoma. More recently, other immune checkpoint inhibitors, including the programmed death-1 (PD-1) inhibitors pembrolizumab and nivolumab, have demonstrated efficacy in locally advanced unresectable and metastatic melanoma...
September 20, 2016: Expert Opinion on Biological Therapy
Matteo Ferrando, Diego Bagnasco, Giovanni Passalacqua, Gilda Varricchi, Giorgio Walter Canonica
INTRODUCTION: Since its introduction in clinical practice one century ago for the treatment of respiratory allergic diseases, allergen-specific immunotherapy (AIT) has exhibited a relevant clinical efficacy that was subsequently confirmed in controlled trials. Thus, AIT has been accepted worldwide, as testified by guidelines and international documents. AIT is considered pivotal in the management of allergic rhinitis with or without conjunctivitis and with or without asthma. These conditions, in addition to hymenoptera venom allergy, currently are the accepted indications...
September 19, 2016: Expert Opinion on Biological Therapy
Yanling Wu, Shibo Jiang, Tianlei Ying
INTRODUCTION: A variety of approaches are being pursued to improve the safety and antitumor potency of chimeric antigen receptor (CAR) T-cell therapy. However, most engineering efforts have thus far been focused on its intracellular signaling domain, while its extracellular antigen-binding domain has received less attention. AREAS COVERED: Herein, the authors summarize the current knowledge of CAR T-cell therapy. Accordingly, they focus on its antigen-binding domain, discuss key considerations for selecting an optimal single-chain variable fragment (scFv) when designing a CAR, and suggest potential directions aimed at developing the next-generation CARs...
September 19, 2016: Expert Opinion on Biological Therapy
Domenico Sambataro, Gianluca Sambataro, Ylenia Dal Bosco, Riccardo Polosa
INTRODUCTION: Primary Sjögren's (pSS) syndrome is a chronic, autoimmune, and systemic disease characterized by xerostomia, xerophthalmia, muscle pain and fatigue. The disease may be complicated by a systemic involvement, such as a pulmonary fibrosis or the development of lymphoma which severely worsens the prognosis. Actually, there are no recommendations for the management of pSS. However, recent advances in the understanding of its pathogenesis have uncovered some pathways that have potential as therapeutic targets...
September 12, 2016: Expert Opinion on Biological Therapy
Shuang Zheng, David J Hunter, Jianhua Xu, Changhai Ding
INTRODUCTION: Osteoarthritis (OA) is a multifactorial chronic joint disease, and so far, there are no approved disease-modifying anti-OA drugs (DMOADs). There is an urgent need to develop therapies for different phenotypes of OA. Monoclonal antibodies (mAb) may slow structural progression, control inflammation and relieve pain, and thus have the potential to be DMOADs. AREAS COVERED: In this review, the authors searched the literature on PubMed, EMBASE and the Cochrane Library using keywords, including mAbs, biological agents, OA and osteoarthritis, electronically up to May 2016...
September 11, 2016: Expert Opinion on Biological Therapy
Bora Nadlacki, Erik J Suuronen
INTRODUCTION: The feasibility and safety of bone marrow cell (BMC) therapy for cardiac repair following myocardial infarction has been demonstrated in clinical studies, albeit with relatively modest structural and functional benefits. In response to the shortcomings of BMC therapy, the use of biomaterials to enhance cell transplantation is being investigated. AREAS COVERED: The authors first review what has been learned from BMC therapies for the treatment of myocardial infarction in animal models and in clinical trials...
September 9, 2016: Expert Opinion on Biological Therapy
Kimberly M Komatsubara, Richard D Carvajal, Adrian G Sacher
No abstract text is available yet for this article.
September 8, 2016: Expert Opinion on Biological Therapy
Camilla Lamb, Patrick Arbuthnot
INTRODUCTION: Chronic infection with hepatitis B virus (HBV) is endemic to several populous parts of the world, where resulting complicating cirrhosis and hepatocellular carcinoma occur commonly. Licensed drugs to treat the infection have limited curative efficacy, and development of therapies that eliminate all replication intermediates of HBV is a priority. AREAS COVERED: The recent demonstration that the activation of the innate immune response may eradicate HBV from infected hepatocytes has a promising therapeutic application...
September 7, 2016: Expert Opinion on Biological Therapy
William M Pardridge
INTRODUCTION: Therapeutic antibodies are large molecule drugs that do not cross the blood-brain barrier (BBB). Therefore, drug development of therapeutic antibodies for Alzheimer's disease (AD) requires that these molecules be re-engineered to enable BBB delivery. This is possible by joining the therapeutic antibody with a transporter antibody, resulting in the engineering of a BBB-penetrating bispecific antibody (BSA). AREAS COVERED: The manuscript covers transporter antibodies that cross the BBB via receptor-mediated transport systems on the BBB, such as the insulin receptor or transferrin receptor...
September 7, 2016: Expert Opinion on Biological Therapy
Zvia Agur, Karin Halevi-Tobias, Yuri Kogan, Ofer Shlagman
INTRODUCTION: Recently, cancer immunotherapy has shown considerable success, but due to the complexity of the immune-cancer interactions, clinical outcomes vary largely between patients. A possible approach to overcome this difficulty may be to develop new methodologies for personal predictions of therapy outcomes, by the integration of patient data with dynamical mathematical models of the drug-affected pathophysiological processes. AREAS COVERED: This review unfolds the story of mathematical modeling in cancer immunotherapy, and examines the feasibility of using these models for immunotherapy personalization...
August 26, 2016: Expert Opinion on Biological Therapy
Roberta Fedele, Nina Salooja, Massimo Martino
INTRODUCTION: Hematopoietic stem cell transplantation (HSCT) is associated with a substantial risk of morbidity and mortality. Better selection of HSCT patients for intensive treatment, and consequently reduction of non-beneficial care, may improve the therapeutic outcome. AREAS COVERED: This manuscript provides a systematic review which examines t he current criteria for selection of HSCT patients. EXPERT OPINION: Identifying patients who may benefit from HSCT involves many factors, including overall health, prior therapies, age, disease, and stage...
August 26, 2016: Expert Opinion on Biological Therapy
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