The Development of Therapeutic Monoclonal Antibodies: Overview of the Nonclinical Safety Assessment

Lansita, Janice A.; Mounho-Zamora, Barbara

doi:10.1007/s11916-014-0472-x

Cited by 3 publications

References 23 publications

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Safety and General Considerations for the Use of Antibodies in Infectious Diseases

Hey

2017

Recombinant Antibodies for Infectious Diseases

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Monocolonal antibodies are valuable potential new tools for meeting unmet needs in treating infectious dieseases and to provide alternatives and supplements to antibiotics in these times of growing resistance. Especially when considering the ability to screen for antibodies reacting to very diverse target antigens and the ability to design and engineer them to work specifically to hit and overcome their strategies, like toxins and their hiding in specific cells to evade the immuneresponse and their special features enabling killing of the infectious agents and or the cells harbouring them. Antibodies are generally very safe and adverse effects of treatments with therapeutic antibodies are usually related to exaggeration of the intended pharmacology. In this chapter general safety considerations for the use of antibodies is reviewed and the general procedures for nonclinical testing to support their clinical development. Special considerations for anti-infective mAb treatments are provided including the special features that makes nonclinical safety programs for anti-infective mAbs much more simple and restricted. However at a cost since only limited information for clinical safety and modeling can be derived from such programs. Then strategies for optimally designing antibodies are discussed including the use of combination of antibodies. Finally ways to facilitate development of more than the currently only three approved mAb based treatments are discussed with a special focus on high costs and high price and how collaboration and new strategies for development in emerging markets can be a driver for this.

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Safety and General Considerations for the Use of Antibodies in Infectious Diseases

Hey

2017

Recombinant Antibodies for Infectious Diseases

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Safety Pharmacology Study Results and their Impact on the Design of First-in-human Trials for Authorised Oncology Therapies

2018

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Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients

Dauti

Gerstl

Chong

et al. 2017

Journal of Adolescent and Young Adult Oncology

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There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.

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The Development of Therapeutic Monoclonal Antibodies: Overview of the Nonclinical Safety Assessment

Cited by 3 publications

References 23 publications

Safety and General Considerations for the Use of Antibodies in Infectious Diseases

Safety and General Considerations for the Use of Antibodies in Infectious Diseases

Safety Pharmacology Study Results and their Impact on the Design of First-in-human Trials for Authorised Oncology Therapies

Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients

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