An Open Label, Randomized, Two-Period, Single Oral Dose, Crossover BE Study of SITAGAVIA (100 mg) of the GPO, Thailand with Januvia of ORGANON PHARMA (UK) LIMITED, United Kingdom in Normal, Healthy, Adult Human Subjects under Fasting Conditions

Start Date15 Jan 2024

Sponsor / Collaborator

The Government Pharmaceutical Organization

NCT05895955 / Active, not recruitingPhase 1/2IIT

A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais

The study is aim to evaluate the safety and immunogenicity of one dose TetraFluvac TF vaccine (15 μg HA per strain per dose) of the GPO seasonal quadrivalent inactivated split virion influenza vaccine in healthy adults aged 18 years and above over 90 days post-injection.

Start Date04 Nov 2023

Sponsor / Collaborator

Mahidol University

[+1]

100 Clinical Results associated with The Government Pharmaceutical Organization

0 Patents (Medical) associated with The Government Pharmaceutical Organization

Literatures (Medical) associated with The Government Pharmaceutical Organization

27 Oct 2023·Scientific reports

Genetic diversity and phylogenetic analyses of Asian lineage Zika virus whole genome sequences derived from Culex quinquefasciatus mosquitoes and urine of patients during the 2020 epidemic in Thailand.

Article

Author: Phumee, Atchara ; Wacharapluesadee, Supaporn ; Intayot, Proawpilart ; Siriyasatien, Padet ; Sutthanont, Nataya ; Chitcharoen, Suwalak

Zika virus (ZIKV), a mosquito-borne flavivirus, has been continually emerging and re-emerging since 2010, with sporadic cases reported annually in Thailand, peaking at over 1000 confirmed positive cases in 2016. Leveraging high-throughput sequencing technologies, specifically whole genome sequencing (WGS), has facilitated rapid pathogen genome sequencing. In this study, we used multiplex amplicon sequencing on the Illumina Miseq instrument to describe ZIKV WGS. Six ZIKV WGS were derived from three samples of field-caught Culex quinquefasciatus mosquitoes (two males and one female) and three urine samples collected from patients in three different provinces of Thailand. Additionally, successful isolation of a ZIKV isolate occurred from a female Cx. quinquefasciatus. The WGS analysis revealed a correlation between the 2020 outbreak and the acquisition of five amino acid changes in the Asian lineage ZIKV strains from Thailand (2006), Cambodia (2010 and 2019), and the Philippines (2012). These changes, including C-T106A, prM-V1A, E-V473M, NS1-A188V, and NS5-M872V, were identified in all seven WGS, previously linked to significantly higher mortality rates. Furthermore, phylogenetic analysis indicated that the seven ZIKV sequences belonged to the Asian lineage. Notably, the genomic region of the E gene showed the highest nucleotide diversity (0.7-1.3%). This data holds significance in informing the development of molecular tools that enhance our understanding of virus patterns and evolution. Moreover, it may identify targets for improved methods to prevent and control future ZIKV outbreaks.

17 Aug 2023·Vaccines

Efficiency Comparative Approach of Plant-Produced Monoclonal Antibodies against Rabies Virus Infection.

Article

Author: Hemachudha, Thiravat ; Rattanapisit, Kaewta ; Mahong, Bancha ; Lumlertdacha, Boonlert ; Phoolcharoen, Waranyoo ; Bulaon, Christine Joy I

Rabies encephalitis is a fatal zoonotic viral disease caused by the neurotropic rabies virus. It remains a major public health concern as it causes almost 100% fatality and has no effective medication after the onset of the disease. However, this illness is preventable with the timely administration of effective post-exposure prophylaxis (PEP) consisting of the rabies vaccine and passive immune globulins (HRIG and ERIG). Recently, conventional PEP has been shown to have many limitations, resulting in little support for these expensive and heterologous globulins. Monoclonal antibody (mAb) production via recombinant technology in animal and human cell cultures, as well as a plant-based platform, was introduced to overcome the costly and high-tech constraints of former preparations. We used transient expression technology to produce two mAbs against the rabies virus in Nicotiana benthamiana and compared their viral neutralizing activity in vitro and in vivo. The expression levels of selective mAbs E559 and 62-71-3 in plants were estimated to be 17.3 mg/kg and 28.6 mg/kg in fresh weight, respectively. The plant-produced mAbs effectively neutralized the challenge virus CVS-11 strain in a cell-based RFFIT. In addition, the combination of these two mAbs in a cocktail protected hamsters from rabies virus infection more effectively than standard HRIG and ERIG. This study suggests that the plant-produced rabies antibody cocktail has promising potential as an alternative biological to polyclonal RIG in rabies PEP.

01 Mar 2023·Anticancer Research

Gene Profiling ofCannabis-sativa-mediated Apoptosis in Human Melanoma Cells

Article

Author: Srisubat, Attasit ; Srihirun, Sirada ; Phetchengkao, Wanthanee ; Suwanpidokkul, Nuntakan ; Tancharoen, Salunya ; Nararatwanchai, Thamthiwat ; Suriyachan, Kankanit ; Poommarapan, Kanita ; Leenutaphong, Petchpailin ; Rummaneethorn, Paisal

BACKGROUND/AIMMalignant melanoma is an aggressive skin cancer, accounting for the majority of skin cancer deaths. Prognosis is often poor and finding effective treatment remains a challenge. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are main bioactive components of Cannabis sativa plant extracts that have been shown to exert anti-tumor effects. In this study, we aimed to perform gene expression analysis of human melanoma A375 cells following stimulation with C. sativa extracts.MATERIALS AND METHODSGene expression profiles of A375 human melanoma and Vero (control) cell lines were evaluated by RNA sequencing and quantitative real-time PCR.RESULTSFlow cytometry showed that the THC+CBD cannabis fractions induced apoptosis on A375 cells. Induction of apoptosis was accompanied by a notable up-regulation of DNA damage inducible transcript 3 (DDIT), nerve growth factor receptor (NGFR), colony-stimulating factor 2 (CSF2), growth arrest and DNA damage inducible beta (GADD45B), and thymic stromal lymphopoietin (TSLP) genes and down-regulation of aryl hydrocarbon receptor nuclear translocator 2 (ARNT2), cyclin E2 (CCNE2), integrin subunit alpha 9 (ITGA9), proliferating cell nuclear antigen (PCNA) and E2F transcription factor 1 (E2F1) genes. Treatment of A375 cells with the THC+CBD fraction inhibited the phosphorylation of ERK1/2 signaling pathway, which regulates melanoma cell proliferation. We showed that the THC+CBD combination disrupted melanoma cell migration.CONCLUSIONUse of C. sativa-derived extracts containing equal amounts of THC and CBD is proposed as a potential treatment of melanoma.

News (Medical) associated with The Government Pharmaceutical Organization

06 Jul 2023

·www.pharmaceutical-technology.com

SK bioscience and Thailand’s GPO enter MoU to boost vaccine response

(From left) Thailand Permanent Secretary of the Ministry of Public Health Dr Opas Karnkawinpong, GPO managing director Dr Mingkwan Suphannaphong, SK bioscience, CEO Jaeyong Ahn and Embassy of the Republic of Korea in Thailand Charge d’affaires ad interim Joyoung Jeon at the MoU at the Ministry of Public Health of Thailand. Credit: SK bioscience. South Korea-based SK bioscience and the Thailand state-owned pharmaceutical company the Government Pharmaceutical Organisation (GPO) have entered a memorandum of understanding (MoU) to bolster vaccine infrastructure in Thailand. The deal will enhance the country’s pandemic response system, aiming to produce Thailand’s vaccines locally. It will then be expanded to the wider southeast Asian region. Recommended Reports Reports Clinical Trials - The Expanding Landscape of Regenerative Medicine GlobalData Reports Innovation in Pharmaceuticals: Recombinant viral vector-based medicinal preparations GlobalData View all Companies Intelligence SK Inc MOU S.A. The Peter Doherty Institute for Infection and Immunity View all The two companies will support vaccine development and manufacturing capabilities in Thailand, working together closely in the mid-to-long-term to support the country as a vaccine hub in southeast Asia. SK bioscience will transfer its cell culture-based influenza vaccine’s production and manufacturing technology to the GPO’s facility. Following this technology transfer, SK bioscience will provide the vaccine’s processes to the Thai company, which will seek marketing authorisation from the regulators. The vaccines produced will be used for the national vaccination drive in Thailand. GPO managing director Dr Mingkwan Suphannaphong stated: “A MoU-signing ceremony between GPO and SK bioscience today substantially contributes to a collaboration on manufacturing the cell-culture based influenza vaccine locally in Thailand, namely the trivalent and quadrivalent inactivated influenza vaccines. “The drug substance bulk produced by SK will be initially delivered to GPO prior to making the drug products.” In June 2023, SK bioscience and the Peter Doherty Institute for Infection and Immunity entered a research partnership to develop a next-generation influenza vaccine.

Vaccine

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