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4 november 2019: 

Zie ook Wikipedia over gendicine:

En ook deze studie: Recombinant human adenovirus-p53 therapy for the treatment of nasopharyngeal carcinoma: a meta-analysis (abstract met referentielijst staat onderaan artikel)

En vooral is deze reviewstudie interessant: The First Approved Gene Therapy Product for Cancer Ad-p53 (Gendicine): 12 Years in the Clinic.

 2018 Feb;29(2):160-179. doi: 10.1089/hum.2017.218.

The First Approved Gene Therapy Product for Cancer Ad-p53 (Gendicine): 12 Years in the Clinic.

Zhang WW1,2Li L3Li D4Liu J5Li X6Li W7Xu X7Zhang MJ8Chandler LA2Lin H7Hu A7Xu W7Lam DM1.


Gendicine (recombinant human p53 adenovirus), developed by Shenzhen SiBiono GeneTech Co. Ltd., was approved in 2003 by the China Food and Drug Administration (CFDA) as a first-in-class gene therapy product to treat head and neck cancer, and entered the commercial market in 2004. Gendicine is a biological therapy that is delivered via minimally invasive intratumoral injection, as well as by intracavity or intravascular infusion. The wild-type (wt) p53 protein expressed by Gendicine-transduced cells is a tumor suppressor that is activated by cellular stress, and mediates cell-cycle arrest and DNA repair, or induces apoptosis, senescence, and/or autophagy, depending upon cellular stress conditions. Based on 12 years of commercial use in >30,000 patients, and >30 published clinical studies, Gendicine has exhibited an exemplary safety record, and when combined with chemotherapy and radiotherapy has demonstrated significantly higher response rates than for standard therapies alone. In addition to head and neck cancer, Gendicine has been successfully applied to treat various other cancer types and different stages of disease. Thirteen published studies that include long-term survival data showed that Gendicine combination regimens yield progression-free survival times that are significantly longer than standard therapies alone. Although the p53 gene is mutated in >50% of all human cancers, p53 mutation status did not significantly influence efficacy outcomes and long-term survival rate for Ad-p53-treated patients. To date, Shenzhen SiBiono GeneTech has manufactured 41 batches of Gendicine in compliance with CFDA QC/QA requirements, and 169,571 vials (1.0 × 1012 vector particles per vial) have been used to treat patients. No serious adverse events have been reported, except for vector-associated transient fever, which occurred in 50-60% of patients and persisted for only a few hours. The manufacturing accomplishments and clinical experience with Gendicine, as well as the understanding of its cellular mechanisms of action and implications, could provide valuable insights for the international gene therapy community and add valuable data to promote further developments and advancements in the gene therapy field.

1 juli 2007: Bron: 1: Int J Hyperthermia. 2005 Nov;21(7):631-6.

Gentherapie met het adenovirus p53 (ook bekend onder gendicine) gecombineerd met hyperthermie zorgt voor uitstekende resultaten bij patienten met een vergevorderde vorm van kanker. 13 van de 15 deelnemende patienten hadden al vele behandelingen zonder succes achter de rug en waren in principe ongeneeslijk. 2 patienten hadden ook vergevorderde kanker maar hadden nog geen enkele behandeling gehad. Hier een letterlijke vertaling van het abstract van de studie. Daaronder een link naar hoe de Nederlandse regering over gentherapie in China denkt nadat een commissie dat onderzocht heeft. Welke opvallend positief is. Plus nog twee links naar meer informatie over gentherapie

De behandeling bereikte een complete respons dus de kanker was klinisch weg (met scans bevestigd) , bij twee patienten, gedeeltelijke respons = meer dan 50% van de tumoren was klinisch verdwenen. Stabiele ziekte, dus geen progressie bij acht patienten en bij slechts 1 patient was sprake van progressie van de ziekte. Na de behandeling verdwenen bij twee patienten de tumoren alsnog en bij 7 van de 13 overgebleven patienten bleek de dichtheid (LDA) van het tumorgebied meer dan 50% op CT scans. Geen enkele patiente ervaarde behandelignsgeraleerde ernstige bijwekringe, hoogstens wat koorts na de Adp53 toediening. Conclusie: Adp53 gecombineerd met hyperthermie was veilig en efectief bij patienten met een vergevorderde kanker. De p53 gen therapie was in potentie warmtegevoelig bij vergevorderde kanker.

Clinical study of recombinant adenovirus-p53 (Adp53) combined with hyperthermia in advanced cancer (a report of 15 cases).
Zhang S, Xu G, Liu C, Xiao S, Sun Y, Su X, Cai Y, Li D, Xu B. Department of Radiotherapy, School of Oncology, Beijing University, No. 52, Fu-Cheng Road, Hai-Dian District Beijing 100036, PR China. The study was to evaluate the efficacy of the Adp53 combined with hyperthermia on advanced cancer. Fifteen patients with advanced cancer were enrolled in this clinical trial. Thirteen patients with recurrent tumours failed in conventional treatments and the two other patients with primary tumour received no treatment before they were enrolled. Recombinant adenovirus-p53 (Adp53) is a E1 substituted replication-incompetent recombinant adenovirus encoding the human wild-type p53 (wtp53) gene. The 15 patients were intra-tumourally injected with Adp53, 1x10(12)vp (virus particle) once a week, with a total of 4-8 times was given. The temperature being set hyperthermia every week 3 days after the injection of Adp53 at 43-44 degrees C using 915 MHz microwave machine for superficial tumour for 1 h or at 42-43 degrees C using 41 MHz radiofrequency machine for deep-seated tumour for 1 h. Among the 15 patients, five concurrently were added with radiotherapy and three were added with cisplatin-based chemotherapy. The treatment achieved CR in two cases, PR in four cases, SD in eight cases and PD in one case and, after the treatment, tumours of two cases disappeared and seven of the other 13 cases (54%) had low-density area (LDA) of more than 50% on CT images in tumours. In the 15 patients, no dose-limiting toxicity and adverse events were noted, except transient fever after Adp53 administration. In conclusion, Adp53 combined with hyperthermia was safe and effective in patients with advanced cancer and p53 gene therapy was potential to thermosensitize in advanced cancer.

PMID: 16304714 [PubMed - indexed for MEDLINE]

De Nederlandse regering schrijft over gendicine en gentherapie het volgende: Gendicine en gentherapie door commissie gentherapie en klik op signalering onderaan pagina voor volledige rapport

Hier nog wat extra informatie over gentherapie (gendicine):

Noorderlicht-VPRO over gentherapie

Gentherapie informatie

Gentherpaie informatie

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