Evidence map›Paper›PMID 36917020›Full record

Trial reportThe oncologist2023

Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma.

Yoshiaki Maruyama, Akira Sakurai, Shinichi Noda, Yasuhiro Fujiwara, Narumi Okura, Toshinori Takagi, Junichi Asano, Futaba Honda

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
8.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Immunotherapy for Cancer: Current Advances and Future Directions.International journal of molecular sciences · 2026
    Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Nucleic acid-based drugs for patients with solid tumours.Nature reviews. Clinical oncology · 2024
    Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Yoshiaki MaruyamaOffice of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.ORCID 0000-0002-9333-7029
Akira SakuraiCenter for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Shinichi NodaOffice of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yasuhiro FujiwaraOffice of New Drug V, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Narumi OkuraOffice of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Toshinori TakagiOffice of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Junichi AsanoBiostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Futaba HondaOffice of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Pharmaceuticals and Medical Devices Agency · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 both copies of the γ34.5 gene have been deleted and the infected cell protein 6 (ICP6) gene has been inactivated by the insertion of the lacZ gene from Escherichia coli. Delytact Injection, when intratumorally administered to patients with malignant glioma, is expected to exert the following effects: (1) the mutant virus selectively replicates in tumor cells and destroys the infected cells through the replication process, exerting a cytocidal effect, and (2) the administration leads to induction of tumor-responsive T cells, which activates antitumor immunity and thus prolongs the survival of patients with malignant glioma. A Japanese phase II study (Study GD01) was conducted in patients with glioblastoma who had residual or recurrent tumors after radiotherapy with concomitant temozolomide. In Study GD01, however, stable disease continued for an extended period in some patients with glioblastoma. Hence, Delytact Injection is expected to be effective to a certain level. In line with this, Delytact Injection has been approved as an option for the treatment of malignant glioma, with one of the 3 approval conditions including conducting a use-results comparison survey and resubmission of the marketing authorization application within the granted time period of 7 years, under the conditional and time-limited approval scheme described in Article 23-26 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Indexed as

Brain NeoplasmsGlioblastomaGliomaOncolytic VirotherapyHumansNeoplasm Recurrence, Localconditional and time-limited approval schemeDelytact Injectiongliomaoncolytic virus therapyPharmaceuticals and Medical Devices Agency (PMDA)Sakigake Designation Systemteserpaturev

Identifiers

PMID36917020
PMCPMC10400161
OpenAlexW4324129451

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.