Journals Expert Opinion on Biological T...

Expert Opinion on Biological Therapy
Evan G Gross, Mohammad A Hamo, Dagoberto Estevez-Ordonez, Nicholas Mb Laskay, Travis J Atchley, James M Johnston, James M Markert
INTRODUCTION: Many pediatric patients with malignant tumors continue to suffer poor outcomes. The current standard of care includes maximum safe surgical resection followed by chemotherapy and radiation which may be associated with considerable long-term morbidity. The emergence of oncolytic virotherapy (OVT) may provide an alternative or adjuvant treatment for pediatric oncology patients. AREAS COVERED: We reviewed seven virus types that have been investigated in past or ongoing pediatric tumor clinical trials: adenovirus (AdV-tk, Celyvir, DNX-2401, VCN-01, Ad-TD-nsIL-12), herpes simplex virus (G207, HSV-1716), vaccinia (JX-594), reovirus (pelareorep), poliovirus (PVSRIPO), measles virus (MV-NIS), and Senecavirus A (SVV-001)...
September 25, 2023: Expert Opinion on Biological Therapy
B√ľke Celikdemir, Roland Houben, Thibault Kervarrec, Mahtab Samimi, David Schrama
INTRODUCTION: Merkel cell carcinoma (MCC) is a rare, highly aggressive form of skin cancer with neuroendocrine features. The origin of this cancer is still unclear but research in the last 15 years has demonstrated that MCC arises via two distinct etiologic pathways, i.e. virus and UV-induced. Considering the high mortality rate and the limited therapeutic options available, this review aims to highlight the significance of MCC research and the need for advancement in MCC treatment...
September 10, 2023: Expert Opinion on Biological Therapy
Nisha Ganesh, Stephen B Hanauer, Parambir S Dulai
INTRODUCTION: Crohn's disease (CD) is a chronic immune-mediated inflammatory bowel disease that results in relapsing and remitting symptoms but progressive transmural bowel damage leading to significant morbidity. CD results from dysregulation of the immune system related to genetic and environmental factors. While the use of monoclonal antibodies targeting cytokines and adhesion molecules have been shown to improve outcomes in CD patients, their widespread use has been limited due to high costs as well as variable access...
August 25, 2023: Expert Opinion on Biological Therapy
Lingbo He, Chun Yang, Yini Wang
INTRODUCTION: Hemophagocytic lymphohistiocytosis (HLH) is a hyperinflammatory syndrome with a dismal prognosis. The underlying causes of HLH are diverse. However, the overabundance of cytokines was shared by all forms of HLH. Cytokine-targeted biotherapies have been increasingly used in HLH treatment. AREAS COVERED: In this review, we aim to provide an overview of biological treatment options for HLH. EXPERT OPINION: Biological therapies offer alternative treatment options for patients with refractory/relapsed HLH or who are intolerant to conventional chemotherapies...
August 25, 2023: Expert Opinion on Biological Therapy
Aditi Saha, Khushali Jhaveri, Humaira Sarfraz, Julio C Chavez
INTRODUCTION: Tisagenlecleucel (tisa-cel) is an anti CD19 CAR-T therapy that has demonstrated clinical activity in R/R large B-cell lymphoma and R/R B-cell acute lymphoblastic leukemia. It showed particularly high efficacy in R/R follicular lymphoma (FL) with a manageable toxicity profile. The pivotal ELARA study in R/R FL confirmed these findings and led to the FDA approval of tisa-cel in R/R FL after two lines of systemic therapies. AREAS COVERED: We start with an introduction of FL and the current treatment landscape with emphasis on the R/R setting...
August 20, 2023: Expert Opinion on Biological Therapy
Nader Hejrati, Raymond Wong, Mohamad Khazaei, Michael G Fehlings
INTRODUCTION: Spinal cord injury (SCI) can lead to severe neurological dysfunction. Despite scientific and medical advances, clinically effective regenerative therapies including stem cells are lacking for SCI. AREAS COVERED: This paper discusses translational challenges related to the safe, effective use of stem cells for SCI, with a focus on mesenchymal stem cells (MSCs), neural stem cells (NSCs), Schwann cells (SCs), olfactory ensheathing cells (OECs), oligodendrocyte precursor cells (OPCs), embryonic stem cells (ESCs), and induced pluripotent stem cells (iPSCs)...
August 20, 2023: Expert Opinion on Biological Therapy
Lorenzo Ferro Desideri, Souska Zandi, Martin S Zinkernagel, Rodrigo Anguita
No abstract text is available yet for this article.
August 18, 2023: Expert Opinion on Biological Therapy
William L Redmond
INTRODUCTION: Costimulatory members of the tumor necrosis factor receptor family, such as O×40(CD134), provide essential survival and differentiation signals that enhance T cell function. Specifically, O×40(CD134) agonists stimulate potent anti-tumor immunity in a variety of preclinical models but their therapeutic impact in patients with advanced malignancies has been limited thus far. AREAS COVERED: In this review, we discuss the current state of combination immunotherapy with O×40agonists including preclinical studies and recent clinical trials...
August 16, 2023: Expert Opinion on Biological Therapy
Aumer Shughoury, Ashay Bhatwadekar, Denis Jusufbegovic, Amir Hajrasouliha, Thomas A Ciulla
INTRODUCTION: Diabetic retinopathy (DR) is a leading cause of blindness worldwide. Recent decades have seen rapid progress in the management of diabetic eye disease, evolving from pituitary ablation to photocoagulation and intravitreal pharmacotherapy. The advent of effective intravitreal drugs inhibiting anti-vascular endothelial growth factor (VEGF) marked a new era in DR therapy. Sustained innovation in DR pharmacotherapy has since produced several promising biologics targeting angiogenesis, inflammation, oxidative stress, and neurodegeneration...
August 14, 2023: Expert Opinion on Biological Therapy
Matthias Calamia, Ivo Abraham
INTRODUCTION: Biologics have shown marked success over the past decades in disease areas as cancer, immunology and diabetes. However, elevated costs of innovative biologic medicines have led to an inequity in accessibility across the world. While 85% of the world's population lives in low- and middle- income countries (LMIC), 80% of the sales of monoclonal antibodies are attributed to Western countries, highlighting the pronounced market imbalance. AREAS COVERED: This perspective paper draws some analogies as well as differences between biosimilars and generics, aims to address the unmet need for treatment with biologics in LMICs by reviewing possible causes, economic and social, of low access, displaying the disparity between LMICs and HIC, and suggets countermeasures for this unmet medical need in LMICs...
August 14, 2023: Expert Opinion on Biological Therapy
Ivo Abraham
No abstract text is available yet for this article.
August 13, 2023: Expert Opinion on Biological Therapy
Simone Ribero, Michela Ortoncelli, Luca Mastorino, Pietro Quaglino, Paolo Dapavo
No abstract text is available yet for this article.
August 8, 2023: Expert Opinion on Biological Therapy
Tomas Gabriel Bas
INTRODUCTION: Biosimilars are gaining popularity in Latin America (LA). The biosimilars market is expected to grow rapidly over the next decade as a cost-effective alternative to expensive patented biologics. The drivers for the growing demand include needs for affordable health care, the prevalence of chronic diseases, expiration of patents for numerous biologic medicines and the advent of artificial intelligence (AI). Countries such as Argentina, Brazil and Mexico have implemented regulatory frameworks for the approval of biosimilars as well as for investment in local manufacturing capacity, sale, and distribution...
August 5, 2023: Expert Opinion on Biological Therapy
Diana Clavellina, Wayne Balkan, Joshua M Hare
INTRODUCTION: Acute myocardial infarction (AMI) remains a leading cause of death in the United States. The limited regenerative capacity of cardiomyocytes and the restricted contractility of scar tissue after AMI are not addressed by current pharmacologic interventions. Mesenchymal stem/stromal cells (MSCs) have emerged as a promising therapeutic approach due to their low antigenicity, ease of harvesting, and efficacy and safety in preclinical and clinical studies, despite their low survival and engraftment rates...
August 5, 2023: Expert Opinion on Biological Therapy
Abdulaali R Almutairi, Ali M Al-Samil, Abdulaziz Alsayyari, Consuela Cheriece Yousef, Mansoor Ahmed Khan, Hani S Alhamdan, Ahmed Al-Jedai
INTRODUCTION: The government of the Kingdom of Saudi Arabia (KSA) has developed a well-defined strategy to restructure the health sector and operate on value-based principles. Biosimilars are a viable option for increasing accessibility while lowering health-care costs. AREAS COVERED: We describe the current and future biosimilar landscape in KSA. We discuss the growth of the biosimilar market, the regulatory approval process, biosimilar adoption, and the potential impact on health-care systems and patient outcomes...
July 28, 2023: Expert Opinion on Biological Therapy
Ana Catalina Hernandez Padilla, Sylvain Meyer, C H Van Werkhoven, Marlieke Ea de Kraker, Bruno Francois
No abstract text is available yet for this article.
July 27, 2023: Expert Opinion on Biological Therapy
Nimer S Alkhatib, Shiraz Halloush, Ivo Abraham
INTRODUCTION: Little is known about the status and the future potential of biosimilars in the Middle East and North Africa (MENA) region. AREAS COVERED: This perspective provides insights into the current regulatory landscape of some MENA countries, currently available biosimilars, the potential of biosimilars in the next decade, and challenges to overcome. EXPERT OPINION: Given the economic and demographic heterogeneity across the MENA countries, biosimilars could reduce significant economic unmet needs in these countries...
July 26, 2023: Expert Opinion on Biological Therapy
Pooja Ghatalia, Jasmeet Kaur, Guru Sonpavde
INTRODUCTION: The standard treatment for muscle-invasive bladder cancer (MIBC) is cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy or upfront radical cystectomy for cisplatin-ineligible patients. In those who are ineligible for or refuse radical cystectomy, trimodal therapy with chemoradiation is offered. However, with the success of immune checkpoint inhibitors (ICI) and antibody-drug conjugates such as enfortumab vedotin in the metastatic setting, several trials are implementing these drugs in the neoadjuvant setting for cisplatin ineligible patients...
July 21, 2023: Expert Opinion on Biological Therapy
Ashish Sharma, Nilesh Kumar, Nikulaa Parachuri, Anat Loewenstein, Francesco Bandello, Baruch D Kuppermann
INTRODUCTION: South Asian countries such as India, South Korea, and Japan have played a key role in spearheading the research and development of biosimilars of the anti-vascular endothelial growth factor (anti-VEGF) ranibizumab for retinal diseases. It is important to understand how this region is preparing for the next decade in the field of anti-VEGF biosimilars for retinal diseases. AREAS COVERED: We discuss the existing anti-VEGF ranibizumab biosimilars along with the biosimilars that might receive approval in the coming decade...
July 20, 2023: Expert Opinion on Biological Therapy
Luca Mastorino, Lorenza Burzi, Giada Frigatti, Alessandra Fazio, Valentina Celoria, Nicole Macagno, Francois Rosset, Stefania Ginevra Passerini, Gabriele Roccuzzo, Anna Verrone, Elena Stroppiana, Michela Ortoncelli, Paolo Dapavo, Pietro Quaglino, Simone Ribero
INTRODUCTION: Psoriasis affecting the genital, palmoplantar, and scalp regions is recognized as difficult-to-treat, and data on the efficacy of biologics in these areas remains limited. RESEARCH DESIGN AND METHODS: This single-center study evaluated the efficacy of anti-IL-17 and anti-IL-23 agents on scalp, genital, and palmoplantar psoriasis. We retrospectively analyzed data from all patients with psoriasis being treated with IL inhibitors at our clinic. Efficacy was evaluated at 16, 28, and 52 weeks, according to the achievement of relative and mean PSSI, PGA-G, and ppPASI...
July 17, 2023: Expert Opinion on Biological Therapy
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