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Biological response modifiers: preclinical evaluation and clinical activity
Abstract:
Biological response modifiers are agents capable of affecting the host immune response toward tumors and include those biological substances produced by the human mammalian cell genome. Interferons and other lymphokines, tumor antigens, antibodies and agents which can activate or stimulate host immune responses are all included in this general category of agents. With the advent of genetic engineering and with monoclonal antibody technology, highly pure preparations of these biological substances can now be produced for tests of activity in preclinical models and in man. As the initial results accrue with highly purified preparations of interferon and with monoclonal antibodies alone or conjugated to toxic substances, the possibility of tumor specific therapy is becoming a reality. The development of preclinical models to predict for clinical activity remains a most important task to attempt to bring to clinical trials the substances most likely to be efficacious as anticancer agents. Early clinical results indicate that many of these agents can give responses in patients with clinically perceptible disease and Phase II activity studies are just beginning to define the range of clinical activity for a variety of biological response modifying agents. The development of biological response modifiers through preclinical testing and into clinical trials will be discussed in detail.
Insights
Biological response modifiers, including interferons and monoclonal antibodies, are emerging as promising tumor-specific therapies. Advances in genetic engineering enable the development of highly pure agents for preclinical and clinical trials, showing early efficacy in cancer treatment.
Area of Science:
- Immunology
- Oncology
- Biotechnology
Background:
- Biological response modifiers (BRMs) are agents that modulate the host immune response against tumors.
- These include interferons, lymphokines, tumor antigens, and antibodies, often derived from the human genome.
- Advances in genetic engineering and monoclonal antibody technology allow for the production of highly purified BRMs.
Purpose of the Study:
- To discuss the development of biological response modifiers for cancer therapy.
- To highlight the role of preclinical models in predicting clinical efficacy.
- To review early clinical results and ongoing Phase II studies of BRMs.
Main Methods:
- Utilizing genetic engineering and monoclonal antibody technology for BRM production.
- Employing preclinical models to assess the activity of BRMs.
- Conducting clinical trials, including Phase II studies, to evaluate efficacy in patients.
Main Results:
- Highly purified interferons and monoclonal antibodies show potential for tumor-specific therapy.
- BRMs, alone or conjugated to toxins, are progressing towards clinical application.
- Early clinical data suggest responses in patients with detectable disease.
Conclusions:
- Biological response modifiers represent a significant advancement in anticancer strategies.
- Continued development and testing are crucial for optimizing BRM therapy.
- The potential for effective, targeted cancer treatment with BRMs is increasingly evident.
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