National early access programs and clinical trials: What opportunities for early access to therapeutic innovations for patients with malignant melanoma?

Cancer ◽  
2021 ◽  
Author(s):  
Emmanuelle Kempf ◽  
Gérard Zalcman ◽  
Céleste Lebbe ◽  
Keyword(s):  
Clinical Trials ◽  
Malignant Melanoma ◽  
Early Access ◽  
Access Programs

scholarly journals Access to innovation through the national early access program and clinical trials for patients with malignant melanoma

Cancer ◽  
2021 ◽  
Author(s):  
Claire Christen ◽  
Laetitia Belgodère ◽  
Bernard Guillot ◽  
Céline Jumeau ◽  
Annie Lorence ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Malignant Melanoma ◽  
Early Access ◽  
Access Program

Clinical Trials on Chemical Radiosensitization of Malignant Melanoma of the Choroid

1979 ◽  
Vol 178 (4) ◽  
pp. 194-197 ◽  
Author(s):  
H. Żygulska-Mach ◽  
Z. Maciejewski ◽  
S. Lukiewicz ◽  
B. Iwasiów ◽  
E. Link
Keyword(s):  
Clinical Trials ◽  
Malignant Melanoma

scholarly journals The New Paradigms in Clinical Research: From Early Access Programs to the Novel Therapeutic Approaches for Unmet Medical Needs

2019 ◽  
Vol 10 ◽  
Author(s):  
Cristina Scavone ◽  
Gabriella di Mauro ◽  
Annamaria Mascolo ◽  
Liberato Berrino ◽  
Francesco Rossi ◽  
...  
Keyword(s):  
Clinical Research ◽  
The Novel ◽  
Therapeutic Approaches ◽  
Medical Needs ◽  
Early Access ◽  
Unmet Medical Needs ◽  
Novel Therapeutic ◽  
Access Programs

scholarly journals Early Access Programs; A Useful Tool to Improve Access for Patients and Manufacturers

2017 ◽  
Vol 20 (9) ◽  
pp. A665
Author(s):  
A Gilbane ◽  
CR Schlegel ◽  
B Rupasinghe ◽  
D Dabor-Alloh ◽  
K Walsh
Keyword(s):  
Early Access ◽  
Improve Access ◽  
Access Programs

scholarly journals Phase I/II Clinical Trial of the Anti-Podoplanin Monoclonal Antibody Therapy in Dogs with Malignant Melanoma

Cells ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. 2529
Author(s):  
Satoshi Kamoto ◽  
Masahiro Shinada ◽  
Daiki Kato ◽  
Sho Yoshimoto ◽  
Namiko Ikeda ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Malignant Melanoma ◽  
Adverse Effects ◽  
Phase I ◽  
Tumor Cells ◽  
Antibody Therapy ◽  
Human Tumor ◽  
Preclinical Trial ◽  
Canine Tumor

Podoplanin (PDPN), a small transmembrane mucin-like glycoprotein, is ectopically expressed on tumor cells. PDPN is known to be linked with several aspects of tumor malignancies in certain types of human and canine tumors. Therefore, it is considered to be a novel therapeutic target. Monoclonal antibodies targeting PDPN expressed in human tumor cells showed obvious anti-tumor effects in preclinical studies using mouse models. Previously, we generated a cancer-specific mouse–dog chimeric anti-PDPN antibody, P38Bf, which specifically recognizes PDPN expressed in canine tumor cells. In this study, we investigated the safety and anti-tumor effects of P38Bf in preclinical and clinical trials. P38Bf showed dose-dependent antibody-dependent cellular cytotoxicity against canine malignant melanoma cells. In a preclinical trial with one healthy dog, P38Bf administration did not induce adverse effects over approximately 2 months. In phase I/II clinical trials of three dogs with malignant melanoma, one dog vomited, and all dogs had increased serum levels of C-reactive protein, although all adverse effects were grade 1 or 2. Severe adverse effects leading to withdrawal of the clinical trial were not observed. Furthermore, one dog had stable disease with P38Bf injections. This is the first reported clinical trial of anti-PDPN antibody therapy using spontaneously occurring canine tumor models.

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