Methods and compositions useful in the treatment of mucositis
Inventors
Hesson, David Paul • Kramer, Michael Scott
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-8497243-B2
Publication Date
2013-07-30
Expiration Date
Abstract
In certain aspects, the present invention provides compositions and methods for treating mucositis.
Core Innovation
The invention provides a method for treating, preventing or reducing the severity of mucositis in a patient by administering, to a patient in need thereof, a therapeutically effective amount of Serum Amyloid P (SAP). The SAP comprises protomers that are each at least 95% identical to the amino acid sequence of SEQ ID NO:1.
The disclosed approach is directed to mucositis associated with radiation and/or chemotherapy, including radiation-induced oral mucositis and radiation-induced enteropathy. The description further encompasses mucositis affecting oral, alimentary, esophageal, and related disorders such as gastric or duodenal ulcers, erosions, colitis and inflammatory bowel disease, and addresses timing relative to a treatment that places the patient at risk of developing mucositis.
Nonclinical data are described showing improvement in radiation injury metrics and mucositis outcomes. In a rat model of radiation-induced enteropathy, hSAP is described as improving radiation-induced enteropathy metrics, including preserved mucosal surface area and reduced subserosal thickening, with a radiation injury score reduction trend. In a hamster cheek pouch model, hSAP is described as reducing severity and onset and duration of radiation-induced oral mucositis, including delayed onset, reduced peak scores, and reduced percentage of days with clinically significant scores.
Claims Coverage
The independent claim recites a mucositis treatment, prevention, or reduction method based on administering a therapeutically effective amount of Serum Amyloid P (SAP) with protomers having specified identity to SEQ ID NO:1. Dependent claims add further definitional limits and outcome framing, including protomer identity thresholds and timing relative to at-risk cancer therapy, with additional refinements that support particular cancer populations and combination approaches.
Administer therapeutically effective SAP to treat, prevent, or reduce mucositis
Administering, to a patient in need thereof, a therapeutically effective amount of Serum Amyloid P (SAP) for treating, preventing or reducing the severity of mucositis.
SAP protomers each at least 95% identical to SEQ ID NO:1
The SAP comprises protomers that are each at least 95% identical to the amino acid sequence of SEQ ID NO:1.
Severity reduced by at least one grade using NCI-Common Toxicity Criteria
Reducing the severity of mucositis by at least one grade according to the National Cancer Institute-Common Toxicity Criteria.
Administration commences prior to the at-risk treatment
The administration commences prior to a treatment that places the patient at risk of developing mucositis.
Protomer identity at least 97% identical to SEQ ID NO:1
The SAP contains protomers whose amino acid sequences are at least 97% identical to the amino acid sequence of SEQ ID NO:1.
Co-administering velafermin
The method further comprises administering a therapeutically effective amount of velafermin.
Overall, the claim set centers on administering therapeutically effective SAP with protomers substantially identical to SEQ ID NO:1 to treat, prevent, or reduce mucositis, with dependent coverage emphasizing NCI-CTC grade reduction, pre-risk timing, tighter protomer identity thresholds, defined cancer patient populations, and optional co-administration with velafermin.
Stated Advantages
Treating, preventing or reducing the severity of mucositis.
Reducing mucositis severity by at least one grade according to the National Cancer Institute-Common Toxicity Criteria.
Improving radiation-induced enteropathy metrics, including preserved mucosal surface area and reduced subserosal thickening, with a radiation injury score reduction trend.
Reducing severity and onset and duration of radiation-induced oral mucositis, including delayed onset, reduced peak scores and reduced percentage of days with clinically significant scores.
Documented Applications
Treatment, prevention or reduction of mucositis in patients at risk due to radiation and/or chemotherapy, including radiation-induced oral mucositis and radiation-induced enteropathy.
Use of the method for mucositis affecting oral, alimentary, and esophageal sites, and related disorders including gastric or duodenal ulcers, erosions, colitis/inflammatory bowel disease.
Nonclinical application of hSAP in rat and hamster cheek pouch models to assess radiation-induced enteropathy and radiation-induced oral mucositis outcomes.
Interested in licensing this patent?