 |
6 Diseases |  |
0 Trials |
|
0 Trials |  |
4 News |  |
- | bococizumab (RN316) / Pfizer
Preclinical, Journal: Regulatory Experience Assessing the Carcinogenic Potential of a Monoclonal Antibody Inhibiting PCSK9, Bococizumab, Including a 2-Year Carcinogenicity Study in Rats. (Pubmed Central) - Aug 31, 2022
The resulting 2-year carcinogenicity study demonstrated no bococizumab-related increase in tumors, confirming the weight-of-evidence evaluation and alleviating concerns regarding the carcinogenic potential. Here we report the scientific and regulatory background that led to the request for a rat carcinogenicity study, the feedback on the design of the carcinogenicity study, and the results from this study which affirmed the original weight-of-evidence assessment of low carcinogenic risk.
- ||| ralpancizumab (RN317) / Pfizer
Trial completion: A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects (clinicaltrials.gov) - Sep 15, 2013
P1, N=136, Completed, Sponsor: Pfizer
Here we report the scientific and regulatory background that led to the request for a rat carcinogenicity study, the feedback on the design of the carcinogenicity study, and the results from this study which affirmed the original weight-of-evidence assessment of low carcinogenic risk. Recruiting --> Completed
- ||| ralpancizumab (RN317) / Pfizer
New P1 trial: A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects (clinicaltrials.gov) - Oct 31, 2012
P1, N=136, Completed, Sponsor: Pfizer