granisetron transdermal (SyB-0701) / Synmosa Biopharma, SymBio Pharma, Abeille Pharma - LARVOL DELTA

GRANISETRON TRANSDERMAL SYSTEM (GTDS) IN PREVENTING NAUSEA AND VOMITING INDUCED BY CISPLATIN-BASED CHEMOTHERAPY AND CONCURRENT RADIOTHERAPY FOR HEAD AND NECK CANCER GRANISTERON CEROTTO TRANSDERMICO (GTDS) NELLA PREVENZIONE DI NAUSEA E VOMITO INDOTTI DA RADIO-CHEMOTERAPIA A BASE DI CISPLATINO PER IL TRATTAMENTO DEI TUMORI DELLA TESTA E COLLO (clinicaltrialsregister.eu) - P2; N=88; Ongoing; Sponsor: G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor

[VIRTUAL] Effect of transdermal granisetron on prevention of nausea and vomiting during chemotherapy of lung cancer (ESMO Asia 2020) - "The granisetron transdermal delivery system (GTDS) has been developed to deliver granisetron continuously over 7 days to prevent CINV. Some previous cases receiving multiday highly emetogenic chemotherapy (HEC) regimens showed that the GTDS plus dexamethasone was not inferior to the GTDS plus dexamethasone and aprepitant...Legal entity responsible for the study: The authors. Funding: Has not received any funding."

Chemotherapy-Induced Nausea and Vomiting • Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Effect of transdermal granisetron on prevention of nausea and vomiting during chemotherapy of lung cancer (ESMO Asia 2020) - "The granisetron transdermal delivery system (GTDS) has been developed to deliver granisetron continuously over 7 days to prevent CINV. Some previous cases receiving multiday highly emetogenic chemotherapy (HEC) regimens showed that the GTDS plus dexamethasone was not inferior to the GTDS plus dexamethasone and aprepitant...Our study indicate that the two regimens therapy provides effective, well-tolerated control of multiday HEC. It offers a alternative route for delivering two regimens for up to 7 days that is as effective as three regimens."

Chemotherapy-Induced Nausea and Vomiting • Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Effect of transdermal granisetron on prevention of nausea and vomiting during chemotherapy of lung cancer (ESMO Asia 2020) - "The granisetron transdermal delivery system (GTDS) has been developed to deliver granisetron continuously over 7 days to prevent CINV. Some previous cases receiving multiday highly emetogenic chemotherapy (HEC) regimens showed that the GTDS plus dexamethasone was not inferior to the GTDS plus dexamethasone and aprepitant...Our study indicate that the two regimens therapy provides effective, well-tolerated control of multiday HEC. It offers a alternative route for delivering two regimens for up to 7 days that is as effective as three regimens."

Chemotherapy-Induced Nausea and Vomiting • Lung Cancer • Oncology • Solid Tumor

Granisetron transdermal system and dexamethasone for the prevention of nausea and vomiting in multiple myeloma patients receiving chemo-mobilization: An observational real-world study of effectiveness and safety. (PubMed, Transfus Apher Sci) - "In real world, GTDS provided an innovative, effective, and well-tolerated control of CINV in MM patients after chemo-mobilization with CY. The study found out effectiveness of a non-invasive delivery system of antiemetic."

Clinical • Journal • Real-World Evidence • Chemotherapy-Induced Nausea and Vomiting • Hematological Malignancies • Multiple Myeloma • Oncology • CSF3

Ultrastructural and optogenetic dissection of V1 corticotectal terminal synaptic properties. (PubMed, J Comp Neurol) - "In contrast, in the majority of non-WFV cells, the amplitude of evoked EPSPs varied across trials. Our results suggest that V1 corticotectal projections may initiate freezing behavior via uniform activation of the WFV cells, which project to the pulvinar nucleus."

Journal

Neural microvascular pericytes contribute to human adult neurogenesis. (PubMed, J Comp Neurol) - "Subsequent in vitro and in vivo experiments confirmed gliogenic and neurogenic capacities of human neural pericytes. Findings foreshadow the bimodal nature of the glio-vascular assembly where pericytes, under instruction from glial cells, can stabilize the quiescent microvasculature or enrich local neuronal microcircuits upon differentiation."

Clinical • Journal • Brain Cancer

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Fudan University

Clinical • New P2 trial • Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Oncology • Oral Cancer

"Come visit @Frumovitz's poster - granisetron patch controls nausea/vomiting from cisplatin chemoradiation RX #ESGO2017 #gyncsm #endcancer" (@ShannonWestin)

Biosimilar • Gynecologic Cancers • Oncology • Solid Tumor • Women's Health

Transdermal granisetron for the prevention of nausea and vomiting following moderately or highly emetogenic chemotherapy in Chinese patients: a randomized, double-blind, phase III study. (PubMed) - Chin Clin Oncol - "GTDS provided effective and well-tolerated control of CINV in Chinese patients, especially to non-cisplatin-contained regimen."

Journal • Biosimilar • Oncology

Observational Case Series Evaluation of the Granisetron Transdermal Patch System (Sancuso) for the Management of Nausea/Vomiting of Pregnancy. (PubMed) - Am J Perinatol - "Objective The objective of this study was to observe the efficacy of antiemetic therapy (no emesis/retching episodes and no rescue medication use) when granisetron is administered via a transdermal patch system (TDS) in women who are 6 to 14 weeks pregnant when compared with oral ondansetron by evaluating the frequency of the use of rescue medications for control of nausea/vomiting of pregnancy (NVP). Results Patients were prescribed rescue antiemetics in 0/3 patients in the granisetron TDS group compared with 2/12 patients in the oral ondansetron group. Conclusion Prospective efficacy studies on the use of granisetron TDS for management of NVP are needed to confirm this clinical observation."

Journal • Biosimilar

Dorsal and Ventral Parts of Thalamic Nucleus Submedius Project to Different Areas of Rat Orbitofrontal Cortex: A Single Neuron-Tracing Study Using Virus Vectors. (PubMed, J Comp Neurol) - "These results indicate that the dorsal and ventral Sm comprise two distinct thalamocortical pathways. The dorsal Sm pathway relay somatosensory information to the ventrolateral orbital area and may be involved in emotional and aversive aspects of nociceptive information processing, whereas the ventral Sm pathway seems to co-activate distant orbitofrontal cortical areas, and may link their functions under certain circumstances."

Journal • Biosimilar

A phase III study of transdermal granisetron versus oral ondansetron for women with gynecologic cancers receiving pelvic chemoradiation. (PubMed, Support Care Cancer) - "Transdermal granisetron was 82% more like to control CINV than oral ondansetron in the late phase of cycle 1 and performed similarly to oral ondansetron in all other cycles. Transdermal granisetron should be considered an option as prophylactic antiemetic therapy for gynecologic cancer survivors undergoing chemoradiation."

Clinical • Journal • P3 data • Cervical Cancer • Chemotherapy-Induced Nausea and Vomiting • Endometrial Cancer • Gynecologic Cancers • Oncology • Palliative care • Solid Tumor • Uterine Cancer • Vaginal Cancer

BMT-08: A Comparative Effectiveness Study of 2 Antiemetic's (clinicaltrials.gov) - P4; N=90; Recruiting; Sponsor: University of Illinois at Chicago

Clinical • HEOR • New P4 trial

Neurons with diverse phenotypes project from the caudal to the rostral nucleus of the solitary tract. (PubMed, J Comp Neurol) - "Although cNST neurons also projected to the P2X2-rich central subdivision, such projections were sparser. These findings suggest that cNST visceral signals exert stronger excitatory and inhibitory influences on local autonomic and reflex pathways associated with the medial and ventral subdivisions compared to weaker modulation of ascending pathways arising from the central subdivision and ultimately destined for the forebrain."

Journal

Dorsal pallidal neurons directly link the nidopallium and midbrain in the zebra finch (Taeniopygia guttata). (PubMed) - "The size and morphology of these neurons were similar to those of large pallidal neurons labeled by calretinin immunoreactivity, which could be co-localized to the same cells. Thus, rather than being directly involved in the control of movement, the large dorsomedial neurons of the caudal dorsal pallidum may be involved in sensory processing, in that they provide an unusual direct link between sensory (auditory/somatosensory) regions of the nidopallium and sensory regions of the intercollicular nucleus of the midbrain."

Journal

Pharmacokinetics and safety of transdermal and oral granisetron in healthy Chinese subjects: An open-label, randomized, crossover study. (PubMed, Int J Clin Pharmacol Ther) - "The C values determined through TD and OA were equivalent, indicating similar drug exposures. Therefore, the granisetron patch may be an alternative formulation for oral granisetron in Chinese individuals.."

Clinical • Journal • PK/PD data

Inhibitory and modulatory inputs to the vocal central pattern generator of a teleost fish. (PubMed, J Comp Neurol) - "Likely sources of these putative modulatory inputs are neurons within or immediately adjacent to vocal CPG neurons. Together with prior neurophysiological investigations, the results reveal potential mechanisms for generating multiple classes of social context-dependent vocalizations with widely divergent temporal and spectral properties."

Journal

GRANISETRON TRANSDERMAL DELIVERY SYSTEM USE IN LYMPHOPROLIFERATIVE DISEASE: A SINGLE CENTER EXPERIENCE (ICML 2019) - "GTDS was used as second line therapy after Ondansetron iv in MEC (Bendamustine, CHOP) and in HEC (Cisplatin-based CHT) instead was used as third line after palonosetron i.v. and Netupitant-Palonosetron p.o. in Dacarbazine based CHT. The GTDS provides effective, well tolerated control of CINV associated with MEC or HEC in one or multi day chemotherapy."

Clinical