Claims for Patent: 7,465,703

Summary for Patent: 7,465,703

Title:	Methods and kits useful for guiding osteoporosis related therapy
Abstract:	The present invention relates to methods and kits useful for guiding the administration of a therapeutic agent in a subject afflicted with, or believed to be afflicted with osteoporosis.
Inventor(s):	Cantor; Thomas L. (El Cajon, CA)
Assignee:	Scantibodies Laboratory, Inc. (Santee, CA)
Application Number:	10/956,760
Patent Claims:	1. A method for guiding administration of a therapeutic agent in a subject afflicted with osteoporosis, comprising: a) obtaining a first biological sample from the subject; b) administering to said subject a parathyroid hormone (PTH) based therapeutic composition comprising PTH1-84 or PTH1-34; c) obtaining a second biological sample from said subject after administration of said therapeutic; and d) evaluating said first and second samples for a PTH antagonist level, and optionally a total PTH level or a PTH1-84 level, wherein the PTH antagonist is PTH7-84, wherein if the PTH antagonist is present at a higher level in the second sample versus the first sample, and/or if the ratio of the PTH antagonist versus the total PTH level or the PTH1-84 level is higher in the second sample versus the first sample, then the subject may be considered a candidate for treatment with said PTH based therapeutic composition, and wherein, if the PTH antagonist is present at the same or lower level in the second sample versus the first sample, and/or if the ratio of the PTH antagonist level versus total PTH level or the PTH1-84 level is the same or lower in the second sample versus the first sample, then the subject is not considered a candidate for treatment with said PTH based therapeutic composition. 2. The method of claim 1, wherein the first and second samples are evaluated for two or more parameters comprising the PTH antagonist level, the total PTH level and/or the PTH1-84 level, and at least two of the parameters are compared. 3. The method of claim 2, wherein the two or more parameters are compared in the form of a ratio or proportion. 4. The method of claim 1, wherein a time period exists between the administering step and obtaining the second biological sample, wherein the time period ranges between about 5 minutes to about 4 hours. 5. The method of claim 1, wherein at least one of the steps a)-d) is performed at a different location and/or by a different person or entity from at least one other of the steps a)-d) of claim 1. 6. The method of claim 1, further comprising evaluating the first and second samples for the presence of a therapeutic inactivating antibody specific for the PTH based therapeutic composition, wherein if the therapeutic inactivating antibody specific for the PTH based therapeutic agent is present, the subject is not considered a candidate for treatment with the PTH based therapeutic composition. 7. The method of claim 1, further comprising administering said PTH based therapeutic composition to said subject if said subject is considered a candidate for treatment with said PTH based therapeutic composition according to step d, or administering a therapeutic agent selected from the group consisting of a bisphosphonate, salmon calcitonin, calcium citrate, and a calcimimetic to said subject if said subject is not considered a candidate for treatment with said PTH based therapeutic composition according to step d. 8. The method of claim 7, wherein the calcimimetic is cinacalcet HCl or AMG-073. 9. The method of claim 1, wherein the subject is determined not to be a candidate for treatment with a PTH based therapeutic agent and the method further comprises administering a therapeutic agent selected from a bisphosphonate, salmon calcitonin, calcium citrate, a calcimimetic, or a combination thereof. 10. The method of claim 1, further comprising obtaining a third biological sample from said subject after obtaining the second biological sample, and evaluating said third sample for a PTH antagonist level, and optionally a total PTH level or a PTH1-84 level, wherein the PTH antagonist is PTH1-84, wherein if the PTH antagonist is present at a higher level in the third sample versus the first sample and/or the second sample, and/or if the ratio of the PTH antagonist versus the total PTH level or the PTH1-84 level is higher in the third sample versus the first sample and/or the second sample, then the subject may be considered a candidate for treatment with said PTH based therapeutic composition, and wherein if the PTH antagonist is present at the same or lower level in the third sample versus the first sample and/or the second sample, and/or if the ratio of the PTH antagonist level versus total PTH level (or the PTH1-84 level) is the same or lower in the third sample versus the first sample and/or the second sample, then the subject is not considered a candidate for treatment with said PTH based therapeutic composition. 11. The method of claim 10, wherein the first and third samples are evaluated for two or more parameters comprising the PTH antagonist level, the total PTH level and/or the PTH1-84 level, and at least two of the parameters are compared. 12. The method of claim 11, wherein the two or more parameters are compared in the form of a ratio or proportion. 13. The method of claim 10, wherein a second time period exists between obtaining the second biological sample and obtaining the third biological sample, wherein the second time period ranges between about 5 minutes to about 4 hours.

Details for Patent 7,465,703

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2023-10-01