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Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma.
Author: AsanoJunichi, FujiwaraYasuhiro, HondaFutaba, MaruyamaYoshiaki, NodaShinichi, OkuraNarumi, SakuraiAkira, TakagiToshinori
Original Abstract of the Article :
In June 2021, the Ministry of Health, Labor and Welfare approved Delytact Injection as a regenerative medical product for oncolytic virus therapy. The active substance of Delytact Injection is teserpaturev, a genetically engineered herpes simplex virus type 1 (strain F) in which the α47 gene and bot...See full text at original site
Dr.Camel's Paper Summary Blogラクダ博士について
ラクダ博士は、Health Journal が論文の内容を分かりやすく解説するために作成した架空のキャラクターです。
難解な医学論文を、専門知識のない方にも理解しやすいように、噛み砕いて説明することを目指しています。
* ラクダ博士による解説は、あくまで論文の要点をまとめたものであり、原論文の完全な代替となるものではありません。詳細な内容については、必ず原論文をご参照ください。
* ラクダ博士は架空のキャラクターであり、実際の医学研究者や医療従事者とは一切関係がありません。
* 解説の内容は Health Journal が独自に解釈・作成したものであり、原論文の著者または出版社の見解を反映するものではありません。
引用元:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10400161/
データ提供:米国国立医学図書館(NLM)
Delytact Injection for Malignant Glioma
In the world of medicine, finding solutions for complex diseases like malignant glioma is like searching for a hidden oasis in a vast desert. This research focuses on the regulatory landscape of a novel oncolytic virus therapy, Delytact Injection, which uses a genetically engineered herpes simplex virus to target and destroy cancerous cells. The study highlights the approval process in Japan, emphasizing the need for post-market surveillance to ensure effectiveness and safety. This is like navigating a treacherous desert path – it's crucial to have clear checkpoints and ongoing monitoring to ensure a safe journey.
Delytact Injection: A New Hope?
The study reveals that Delytact Injection demonstrated some efficacy in a phase II clinical trial. While the results were promising, further research is needed to solidify its role in treating malignant glioma. It's like discovering a spring in the desert, but we need to ensure it's a sustainable source of water before we declare it a true oasis.
Navigating the Treatment Landscape
The approval of Delytact Injection under a conditional and time-limited scheme underscores the importance of ongoing research and careful evaluation. This approach reflects the cautious optimism of the medical community – it's like taking a step forward in the desert, but with a watchful eye on the surrounding landscape.
Dr.Camel's Conclusion
This study offers a glimpse into the exciting world of oncolytic virus therapy for malignant glioma. While Delytact Injection holds promise, it's crucial to continue researching and monitoring its long-term effects. After all, a successful journey through the desert requires perseverance, careful observation, and a willingness to adapt to the ever-changing landscape.
Date :
- Date Completed 2023-08-07
- Date Revised 2023-08-07
Further Info :
Related Literature
English
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