US 11,813,339 B2
Method of use for therapeutic bone agents
Jaime Simon, Angleton, TX (US); and R. Keith Frank, Lake Jackson, TX (US)
Assigned to IGL PHARMA, INC., Angleton, TX (US)
Appl. No. 16/484,706
Filed by IGL Pharma, Inc., Angleton, TX (US)
PCT Filed Feb. 6, 2018, PCT No. PCT/US2018/017082
§ 371(c)(1), (2) Date Aug. 8, 2019,
PCT Pub. No. WO2018/148209, PCT Pub. Date Aug. 16, 2018.
Claims priority of provisional application 62/456,191, filed on Feb. 8, 2017.
Prior Publication US 2021/0138095 A1, May 13, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 51/00 (2006.01); A61M 36/14 (2006.01); A61K 51/04 (2006.01); A61P 35/00 (2006.01); A61P 35/04 (2006.01); A61P 19/08 (2006.01); A61P 7/00 (2006.01); G21G 1/02 (2006.01)
CPC A61K 51/0482 (2013.01) [A61K 51/0478 (2013.01); A61P 35/00 (2018.01); A61P 7/00 (2018.01); A61P 19/08 (2018.01); A61P 35/04 (2018.01); G21G 1/02 (2013.01)] 10 Claims
 
1. A method for the treatment of a patient having bone pain, one or more calcific tumors, or in need of a bone marrow suppressing procedure, comprising administering to said patient Multiple Doses of a pharmaceutically-acceptable formulation of a chelate composition comprising a Clinically Relevant Dosage of the composition of about 0.5 mCi per kg body weight or about 30 mCi for a 70 kg patient, or about 1.0 mCi per kg body weight or about 70 mCi for a 70 kg patient that is therapeutically effective without a quantifiable accumulation of long-lived isotopes and about 50% reduced myelosuppression in the patient, said composition possessing an extended Expiration Date of Sm-153 used to prepare the composition of greater than or equal to about 5 days based on Eu-154 present in the formulation being less than 0.093 μCi Eu-154/mCi Sm-153 and said chelate comprises LSA Sm-153 and DOTMP or a physiologically-acceptable salt thereof.