Abstract: Provided are methods for treating patients with type 1 diabetes, wherein the patient has new onset type 1 diabetes no more than eight months before starting treatment, and has not previously received an immunomodulatory agent. Also provided are methods for improving cell health in a patient having type 1 diabetes. Also provided are methods for preserving residual C-peptide in a patient having type 1 diabetes. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine while the patient is maintained on a low polyamine diet, wherein the method prevents, delays, decreases the likelihood of, or decreases the severity of diabetic ketoacidosis severe hypoglycemia, progression of diabetic nephropathy and retinopathy.

Abstract: The present invention provides methods and kits a) for preventing and/or treating neuroblastoma (e.g., high-risk neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patients whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene. The invention also provides, cancer treatment methods comprising the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection, which includes, in some aspects the administration of pharmaceutically effective amounts of ?-difluoromethylornithine (DFMO), either as a monotherapy or in combination with one or more other drugs.

Abstract: Provided are methods for preventing or delaying the need for surgical intervention in a patient having familial adenomatous polyposis (FAP) and an at least partially intact lower gastrointestinal tract. Also provided are methods for preventing or delaying the formation of neoplasia and/or cancer in a patient having FAP. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine and sulindac to a patient having FAP and an intact lower gastrointestinal tract.

Abstract: The present invention provides methods and kits a) for preventing and/or treating neuroblastoma (e.g., high-risk neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patients whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene. The invention also provides, cancer treatment methods comprising the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection, which includes, in some aspects the administration of pharmaceutically effective amounts of ?-difluoromethylornithine (DFMO), either as a monotherapy or in combination with one or more other drugs.

Abstract: The present invention provides methods and kits a) for preventing and/or treating neuroblastoma (e.g., high-risk neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patients whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene. The invention also provides, cancer treatment methods comprising the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection, which includes, in some aspects the administration of pharmaceutically effective amounts of ?-difluoromethylornithine (DFMO), either as a monotherapy or in combination with one or more other drugs.

Abstract: Provided are methods for preventing or delaying the need for surgical intervention in a patient having familial adenomatous polyposis (FAP) and an at least partially intact lower gastrointestinal tract. Also provided are methods for preventing or delaying the formation of neoplasia and/or cancer in a patient having FAP. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine and sulindac to a patient having FAP and an intact lower gastrointestinal tract.

Abstract: The present invention provides methods and kits a) for preventing and/or treating neuroblastoma (e.g., high-risk neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patients whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene. The invention also provides, cancer treatment methods comprising the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection, which includes, in some aspects the administration of pharmaceutically effective amounts of ?-difluoromethylornithine (DFMO), either as a monotherapy or in combination with one or more other drugs.

Abstract: Provided are methods for preventing or delaying the need for surgical intervention in a patient having familial adenomatous polyposis (FAP) and an at least partially intact lower gastrointestinal tract. Also provided are methods for preventing or delaying the formation of neoplasia and/or cancer in a patient having FAP. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine and sulindac to a patient having FAP and an intact lower gastrointestinal tract.

Abstract: The present invention relates to therapeutic methods and medical uses comprising the identification and use of cancer marker surrogates for increased polyamine expression. These markers may be used to identify patients who may be treated for diseases and disorders that are susceptible to polyamine synthesis inhibitors, and they can also be used to monitor therapeutic responses when such agents are used.

Abstract: Provided are methods for preventing or delaying the need for surgical intervention in a patient having familial adenomatous polyposis (FAP) and an at least partially intact lower gastrointestinal tract. Also provided are methods for preventing or delaying the formation of neoplasia and/or cancer in a patient having FAP. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine and sulindac to a patient having FAP and an intact lower gastrointestinal tract.

Abstract: The present invention provides methods and kits a) for preventing and/or treating cancer (e.g., colorectal cancer, neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patient's whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting the corresponding treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene as well as cancer treatment methods, in each case, which include the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection.

Abstract: The present invention relates to therapeutic methods and medical uses comprising the identification and use of cancer marker surrogates for increased polyamine expression. These markers may be used to identify patients who may be treated for diseases and disorders that are susceptible to polyamine synthesis inhibitors, and they can also be used to monitor therapeutic responses when such agents are used.

Abstract: The present invention provides methods and kits a) for preventing and/or treating neuroblastoma (e.g., high-risk neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patients whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene. The invention also provides, cancer treatment methods comprising the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection, which includes, in some aspects the administration of pharmaceutically effective amounts of ?-difluoromethylomithine (DFMO), either as a monotherapy or in combination with one or more other drugs.

Abstract: The present disclosure relates to therapeutic methods and medical uses comprising the identification and use of cancer marker surrogates for increased polyamine expression. These markers may be used to identify patients who may be treated for diseases and disorders that are susceptible to polyamine synthesis inhibitors, and they can also be used to monitor therapeutic responses when such agents are used. More specifically, reduced levels of let-7 miRNA and elevated levels of LIN28 and HMGA2 proteins were found to correlate with elevated levels of polyamines and may be used for predicting the efficacy of cancer therapy using an ornithine decarboxylase (ODC1) inhibitor such as eflornithine (DFMO), suitably in combination with an NSAID such as sulindac.

Abstract: The present invention provides methods and kits a) for preventing and/or treating cancer (e.g., colorectal cancer, neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patient's whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting the corresponding treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene as well as cancer treatment methods, in each case, which include the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection.

Abstract: The present disclosure relates to therapeutic methods and medical uses comprising the identification and use of cancer marker surrogates for increased polyamine expression. These markers may be used to identify patients who may be treated for diseases and disorders that are susceptible to polyamine synthesis inhibitors, and they can also be used to monitor therapeutic responses when such agents are used. More specifically, reduced levels of let-7 miRNA and elevated levels of LIN28 and HMGA2 proteins were found to correlate with elevated levels of polyamines and may be used for predicting the efficacy of cancer therapy us ing an ornithine decarboxylase (ODC1) inhibitor such as eflornithine (DFMO), suitably in combination with an NSAID such as sulindac.

Abstract: The present invention provides methods and kits a) for predicting colorectal cancer patient survival, as well as the survival of patients harboring other invasive cancers where cellular proliferation and carcinogenesis is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and b) for selecting the corresponding treatment options for such patients based on the allelic nucleotide sequence or SNP at position +316 of the ODC1 promoter gene as well as cancer treatment methods, in each case, which include the determination of the ODC1 promoter +316 position genotype, as a means to guide treatment selection.

Abstract: The present invention provides methods and kits a) for predicting colorectal cancer patient survival, as well as the survival of patients harboring other invasive cancers where cellular proliferation and carcinogenesis is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and b) for selecting the corresponding treatment options for such patients based on the allelic nucleotide sequence or SNP at position +316 of the ODC1 promoter gene as well as cancer treatment methods, in each case, which include the determination of the ODC1 promoter +316 position genotype, as a means to guide treatment selection.

Abstract: Methods and compositions are provided for transgene expression in target cells. Expression constructs using an inducible amplification system to drive expression of a therapeutic gene or other gene of interest in mammalian host cells are provided, as well as methods therefor. Inducible expression of the transgenes at high levels under physiologic conditions results from induction by hyperthermic conditions relative to the basal temperature of the host cells.

Abstract: Expression constructs using an inducible amplification system to drive expression of a therapeutic gene or other genes of interest in mammalian cells are provided, as well as methods of using the same.