Claims for Patent: 8,298,770

Summary for Patent: 8,298,770

Title:	Methods, kits, and antibodies for detecting parathyroid hormone
Abstract:	The present invention relates to novel methods and compositions useful for detecting whole parathyroid hormone at a physiological level and parathyroid fragments in a mammalian sample. Such detections may be useful to different parathyroid diseases or disorders in a subject, such as hyperparathyroidism and related bone diseases, from normal or non-disease states. One detects whole or non-fragmented (1 to 84) parathyroid hormone in a biological sample and optionally one or more of a selection of non-whole parathyroid hormone peptide fragments that may or may not function as a parathyroid hormone antagonists. By either comparing values or using independently the value of either the one or more of a selection of non-whole parathyroid hormone peptide fragments, the whole parathyroid hormone, or the combination of these values one is able to differentiate parathyroid and bone related disease states, as well as differentiate such states from normal states.
Inventor(s):	Cantor; Thomas L. (El Cajon, CA), Gao; Ping (San Diego, CA)
Assignee:	Scantibodies Laboratory, Inc. (Santee, CA)
Application Number:	11/799,726
Patent Claims:	1. An isolated parathyroid hormone (PTH) peptide, which is selected from the group consisting of PTH.sub.2-5, PTH.sub.2-6, PTH.sub.2-8, PTH.sub.2-9, PTH.sub.2-11, PTH.sub.2-12, PTH.sub.2-13, PTH.sub.2-16, PTH.sub.2-17, PTH.sub.2-18, PTH.sub.2-19, PTH.sub.2-20, PTH.sub.2-21, PTH.sub.2-22, PTH.sub.2-23, PTH.sub.2-24, PTH.sub.2-25, PTH.sub.2-26, PTH.sub.2-27, PTH.sub.2-30, PTH.sub.2-31, PTH.sub.2-32, and PTH.sub.2-33. 2. The isolated PTH peptide of claim 1, which is conjugated to a carrier to enhance the PTH peptide's immunogenicity. 3. The isolated PTH peptide of claim 2, wherein the carrier is a carrier protein. 4. The isolated PTH peptide of claim 3, wherein the PTH peptide and the carrier protein are parts of a fusion protein. 5. An immunogen, which immunogen comprises: a) a PTH peptide of claim 1; and b) an immune response potentiator. 6. The immunogen of claim 5, wherein the immune response potentiator is selected from the group consisting of Bacille Calmette-Guerin (BCG), Corynebacterium Parvum, Brucella abortus extract, glucan, levamisole, tilorone, an enzyme and a non-virulent virus. 7. A method for producing an antibody to a parathyroid hormone (PTH) or a PTH peptide, which method comprises: a) introducing an isolated PTH peptide of claim 1 to a mammal in an amount sufficient to produce an antibody to said PTH peptide; and b) recovering said antibody from said mammal. 8. An antibody to a PTH or a PTH peptide produced by the method of claim 7. 9. A kit for producing an antibody to a parathyroid hormone (PTH) or a PTH peptide, which kit comprises: a) an isolated PTH peptide of claim 1; b) means for introducing said isolated PTH peptide to a mammal in an amount sufficient to produce an antibody to said PTH peptide; and c) means for recovering said antibody from said mammal. 10. A method for producing an antibody to a parathyroid hormone (PTH) or a PTH peptide, which method comprises: a) introducing a PTH protein or peptide from between PTH.sub.1-34 and PTH.sub.1-84 to a mammal in an amount sufficient to produce an antibody to said PTH protein or peptide; b) recovering said antibody from said mammal; and c) affinity purifying a PTH antibody that specifically binds to an epitope comprised in a PTH peptide of claim 1 using said PTH peptide of claim 1. 11. An antibody to a PTH or a PTH peptide produced by the method of claim 10. 12. A kit for producing an antibody to a parathyroid hormone (PTH) or a PTH peptide, which kit comprises: a) a PTH protein or peptide from between PTH.sub.1-34 and PTH.sub.1-84; b) means for introducing said PTH protein or peptide from between PTH.sub.1-34 and PTH.sub.1-84 to a mammal in an amount sufficient to produce an antibody to said PTH protein or peptide; c) means for recovering said antibody from said mammal; and d) a PTH peptide of claim 1. 13. A method for producing an antibody to a parathyroid hormone (PTH), which method comprises: a) introducing a PTH.sub.1-84 to a mammal in an amount sufficient to produce an antibody to said PTH.sub.1-84; b) recovering said antibody from said mammal; and c) affinity purifying a PTH antibody that specifically binds to an epitope comprised in said PTH.sub.1-84 using PTH.sub.4-16. 14. An antibody to a PTH.sub.1-84 produced by the method of claim 13. 15. A kit for producing an antibody to a PTH.sub.1-84, which kit comprises: a) a PTH.sub.1-84; b) means for introducing said PTH.sub.1-84 to a mammal in an amount sufficient to produce an antibody to said PTH.sub.1-84; c) means for recovering said antibody from said mammal; and d) PTH.sub.4-16.

Details for Patent 8,298,770

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2019-01-14