Judge halts gene-splicing experiment.
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This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on October 6, 1989. After consideration of these proposals and comments by the RAC, the Acting Director of the National Institutes of Health will issue decisions in accordance with the NIH Guidelines.
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This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on October 16, 1990. After consideration of these proposals and comments by the RAC, the Director of the National Institutes of Health will issue decisions in accordance with the NIH Guidelines.
This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on February 4, 1991. After consideration of these proposals and comments by the RAC, the Director of the National Institutes of Health will issue decisions in accordance with the NIH Guidelines.
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Explore the source record for details and available documents.
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Explore the source record for details and available documents.
This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on September 21, 1987. After consideration of these proposals and comments by the RAC, the Director of the National Institutes of Health will issue a decision on these proposals in accord with the NIH Guidelines.
We recently completed a phase I trial of E1A gene therapy for patients with advanced breast or ovarian cancers. The trial's rationale was that E1A gene would downregulate HER-2/neu expression by repressing the gene's transcription, thus reversing the malignant phenotype. Our preclinical studies showed that i) transfection capabilities were not reduced in preparing E1A/cationic liposome complexes, ii) samples after ex vivo transfection, and iii) HER-2/neu gene expression could be quantified by quantitative imaging analysis. These results facilitated the translation of our basic research findings into a clinical trial and to obtain final approval from the National Institutes of Health Recombinant DNA Advisory Committee.
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BACKGROUND: Molecular or gene therapy involves the introduction of genetic material (DNA) into host cells to induce the expression of the therapeutic product of that gene. This ability to transfer genetic material provides a novel approach for the investigation and potential treatment of a variety of both inherited and acquired diseases. METHODS: This review summarizes the principles of molecular therapy and potential strategies for its use in the treatment of solid malignancies. Some molecular therapy strategies permanently integrate the gene into the targeted cells, whereas others induce only transient expression of a therapeutic gene product. Initial clinical studies in gene therapy are being closely regulated for public safety by both the National Institutes of Health Recombinant DNA Advisory Committee and the U.S. Food and Drug Administration. CONCLUSIONS: These studies will provide insight into further applications of gene therapy and novel molecular interventions that may alter our management of solid malignancies; they may also reveal mechanisms for preventing or reversing the carcinogenic process.