Claims for Patent: 7,943,323

Summary for Patent: 7,943,323

Title:	Methods for differentiating and monitoring parathyroid and bone status related diseases
Abstract:	The present invention relates to novel methods and devices for differentiating in a patient parathyroid diseases, 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 also a large non-whole parathyroid hormone peptide fragment that can function as a parathyroid hormone antagonist. By either comparing values or using independently the value of either the large non-whole parathyroid hormone peptide fragment, 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:	10/641,780
Patent Claims:	1. A method for producing an antibody for specifically detecting whole PTH.sub.1-84 while avoiding detecting an interfering non-(1-84) parathyroid hormone fragment in a biological sample, which method comprises: a) administering a first peptide or protein immunogen to a host animal to induce antibody production against said first peptide or protein immunogen in said host animal, said first peptide or protein immunogen being human, rat, bovine, or porcine PTH.sub.1-84; b) monitoring antibody titer produced by said administration of said first peptide or protein immunogen to said host animal; c) extracting antiserum produced in said host animal by said administration of said first peptide or protein immunogen; and d) purifying said antiserum and selecting an antibody from said antiserum extracted in step c) by affinity chromatography utilizing a second peptide or protein immunogen, which is human PTH.sub.1-8, rat PTH.sub.1-8, or a peptide having at least four amino acids in the common sequence of human and rat PTH.sub.1-8. 2. The method of claim 1, wherein in step a), the host animal is a goat. 3. The method of claim 1, wherein the interfering non-(1-84) parathyroid hormone fragment is PTH.sub.7-84. 4. The method of claim 1, wherein the first peptide or protein immunogen is human PTH.sub.1-84. 5. The method of claim 1, wherein the first peptide or protein immunogen is rat PTH.sub.1-84. 6. The method of claim 1, wherein the first peptide or protein immunogen is bovine PTH.sub.1-84. 7. The method of claim 1, wherein the first peptide or protein immunogen is porcine PTH.sub.1-84. 8. The method of claim 1, wherein the first peptide or protein immunogen is human PTH.sub.1-84, the second peptide or protein immunogen is human PTH.sub.1-8, and the interfering non-(1-84) parathyroid hormone fragment is PTH.sub.7-84. 9. The method of claim 1, wherein the first peptide or protein immunogen is rat PTH.sub.1-84, the second peptide or protein immunogen is rat PTH.sub.1-8, and the interfering non-(1-84) parathyroid hormone fragment is PTH.sub.7-84. 10. The method of claim 1, wherein the interfering non-(1-84) parathyroid hormone fragment is a peptide having an amino acid sequence from between PTH.sub.3-84 and PTH.sub.34-84 and functions in vivo as a wPTH antagonist or inhibitor. 11. The antibody produced by the method of claim 1. 12. The antibody of claim 11, wherein the antibody is a polyclonal antibody. 13. The antibody of claim 11, wherein the antibody is a monoclonal antibody. 14. The antibody of claim 11, wherein the antibody further comprises a label. 15. The antibody of claim 14, wherein the label is selected from the group consisting of a chemiluminescent agent, a colorimetric agent, an energy transfer agent, an enzyme, a fluorescent agent and a radioisotope. 16. The antibody of claim 11, wherein the antibody is bound to a solid support. 17. The antibody of claim 16, wherein the solid support is a colloidal solid support or a latex particle. 18. A method for producing an antibody for specifically detecting whole PTH.sub.1-84 while avoiding detecting an interfering non-(1-84) parathyroid hormone fragment in a biological sample, which method comprises: a) administering human, rat, bovine, or porcine PTH.sub.1-84 to a host animal to induce antibody production against said human, rat, bovine, or porcine PTH.sub.1-84; b) recovering antiserum produced in said host animal by said administration of said human, rat, bovine, or porcine PTH.sub.1-84; and c) purifying an antibody that specifically binds to whole PTH.sub.1-84 while avoiding detecting an interfering non-(1-84) parathyroid hormone fragment in a biological sample from said antiserum using human PTH.sub.1-8, rat PTH.sub.1-8, or a peptide having at least four amino acids in the common sequence of human and rat PTH.sub.1-8. 19. The antibody produced by the method of claim 18.

Details for Patent 7,943,323

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