Method for lowering serum glucose

Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Polymer from ethylenic monomers only

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C424S078360, C424S078370

Reexamination Certificate

active

10125700

ABSTRACT:
A method for treating hyperglycemia and/or reducing serum glucose levels in a patient that includes administering to the patient a therapeutically effective amount of an amine polymer is disclosed. In one embodiment, the amine polymer is aliphatic. Examples of polymers useful in an embodiment of the invention include sevelamer hydrogen chloride and colesevelam. The invention includes the use of amine polymers such as a cross-linked polymer characterized by a repeat unit having the formula:and salts and copolymers thereof, where n is a positive integer and x is zero or an integer between 1 and about 4. Also described is a use, for the manufacture of a medicament, of a polymer that lowers serum glucose.

REFERENCES:
patent: 4528347 (1985-07-01), Harada et al.
patent: 4605701 (1986-08-01), Harada et al.
patent: 5468727 (1995-11-01), Phillips et al.
patent: 5487888 (1996-01-01), Mandeville, III et al.
patent: 5496545 (1996-03-01), Holmes-Farley et al.
patent: 5607669 (1997-03-01), Mandeville, III et al.
patent: 5618530 (1997-04-01), Mandeville, III et al.
patent: 5624963 (1997-04-01), Mandeville, III et al.
patent: 5667775 (1997-09-01), Holmes-Farley et al.
patent: 5679717 (1997-10-01), Mandeville, III et al.
patent: 5693675 (1997-12-01), Mandeville, III et al.
patent: 5702696 (1997-12-01), Mandeville, III et al.
patent: 5703188 (1997-12-01), Mandeville, III et al.
patent: 5900475 (1999-05-01), Mandeville, III et al.
patent: 5925379 (1999-07-01), Mandeville, III et al.
patent: 6083495 (2000-04-01), Holmes-Farley et al.
patent: 6083497 (2000-07-01), Huval et al.
patent: 6177478 (2001-01-01), Holmes-Farley et al.
patent: 6203785 (2001-03-01), Holmes-Farley et al.
patent: 6407178 (2002-06-01), Kolbe et al.
patent: 6569905 (2003-05-01), Sikorski et al.
patent: 2002/0031763 (2002-03-01), Kolbe et al.
patent: 2002/0198202 (2002-12-01), Gwynne et al.
patent: 0 997 148 (2000-05-01), None
patent: 6321787 (1994-11-01), None
patent: WO98/57652 (1998-12-01), None
patent: WO99/22743 (1999-05-01), None
patent: WO99/40990 (1999-08-01), None
patent: WO01/25291 (2001-04-01), None
patent: WO 01/25291 (2001-04-01), None
Wizeman, W.J., and Kofinas, P., “Molecularly Imprinted Polymer Hydrogels Displaying Isomerically Resolved Glucose Binding,”Biomaterials, 22: 1485-1491 (2001).
Garg, A., and Grundy, S.M., “Cholestyramine Therapy for Dyslipidemia in Non-Insulin Diabetes Mellitus: A Short-Term, Double-Blind, Crossover Trial,”Annals of Internal Medicine, 121(6):416-422 (1994).
“Dietary Guidelines for Americans,”Home and Garden Bulletin No. 232(Fifth Edition), (2000).
Clinical Study Report generated by “The SAS System,” (Mar. 23, 2000).
Jones, R., “Colesevelam Hydrochloride,”Current Opinion in Cardiovascular, Pulmonary&Renal Investigational Drugs., 2(3):284-291(2000).
Insull, W., et al., “Colesevelam, A Novel, Potent, Polymeric Bile Acid Sequestrant Significantly Lowers LDL Cholesterol,”Presented at the 5thInternational Symposium on Multiple Risks Factors in Cardiovascular Disease: Global Assessment and Intervention, Venice, Italy Oct. 28-31, 1999. (Abstract and Poster).
Ose, L., et al., “Once Per Day And Split Dosing Of Colesevelam In Patients With Type IIa Hypercholesterolemia,”Presented at the 5thInternational Symposium on Multiple Risks Factors in Cardiovascular Disease: Global Assessment and Intervention, Venice, Italy Oct. 28-31, 1999. (Abstract and Poster).
Davidson, M.H., et al., “A New, Bile Acid Sequestrant Associated With A Low Incidence Of Gastrointestinal Side Effects,”Arch Intern Med., 159:1893-1900(1999).
Mesner, C.H., et al., “Effect Of Cholestagel And Lovastatin Alone And In Combination For The Treatment Of Hypercholesterolemia,”Presented at the XIII International Symposium On Drugs Affecting Lipid Metabolism,Florence, Italy; May 30, 1998-Jun. 3, 1998. (Abstract).
Heller D., et al., “Absorption of14C-Colesevelam Hydrochloride In Normal Volunteers,”Presented at the 1999 AAPS Annual Meeting And Exposition. New Orleans, LA. Nov. 14-18, 1999. (Abstract).
Declaration Of Joanne Donovan Under 37 C.F.R. 1.132.
“Welchol™ Tablets Package Insert”,Center for Drug Evaluation and Research, Application Number: NDA 21-176, pp. 1-11, and NDA 21-141, pp. 1-11.
“Renagel® Package Insert”,GelTex Pharmaceuticals, Inc., Waltham, Massachusetts, 4712 (Jul. 2000), Issued XX/00, pp. 1-10.
Dennis I. Goldberg, et al.,“Effect of RenaGel®, a non-absorbed, calcium-and aluminium-free phosphate binder, on serum phosphorus, calcium, and intact parathyroid hormone in end-stage renal disease patients,”Nephrol Dial Transplant, 13:2303-2310, (1998).
Glenn M. Chertow, MD, MPH, et al., “Poly [allylamine Hydrochloride] (RenaGel): A Noncalcemic Phosphate Binder for the Treatment of Hyperphosphatemia in Chronic Renal Failure,”American Journal of Kidney Diseases, vol. 29, No. 1, pp. 66-71, (1997).
G.M. Chertow, et al., “A Randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium,”Clinical Nephrology, vol. 51, No. 1, pp. 18-26, (1999).
Anthony J. Bleyer, MD, MS, et al., “A Comparison of the Calcium-Free Phosphate Binder Sevelamer Hydrochloride With Calcium Acetate in the Treatment of Hyperphosphatemia in Hemodialysis Patients,”American Journal of Kidney Diseases, vol. 33, No. 4, pp. 694-701, (1999).
Eduardo A. Slatopolsky, et al., “RenaGel®, a nonabsorbed calcium-and aluminum-free phosphate binder, lowers serum phosphorus and parathyroid hormone,”Kidney International, vol. 55, pp. 299-307, (1999).
Glenn M. Chertow, et al., “Long-term effects of sevelamer hydrochloride on the calcium x phosphate product and lipid profile of haemodialysis patients,”Nephrol Dial Transplant, 14:2907-2914, (1999).
G.M. Chertow, et al., “Hyperparathyroidism and dialysis vintage,”Clinical Nephrologyvol. 54, No. 4, pp. 295-300, (2000).
Steven K. Burke, “RenaGel®: reducing serum phosphorus in haemodialysis patients,”Reprinted from Hospital Medicine, vol. 61, No. 9, (2000).
Glenn M. Chertow, et al., “Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients,”Kidney International, vol. 62, pp. 245-252, (2002).
Glenn M. Chertow, MD, MPH, et al., “Sevelamer With and Without Calcium and Vitamin D: Observations From a Long-Term Open-Label Clinical Trial,”Journal of Renal Nutrition, vol. 10, No. 3, pp. 125-132, (2000).
A.J. Collins, et al., “Hospitalization risks between Renagel phosphate binder treated and non-Renagel treated patients,”Clinical Nephrology, vol. 54, No. 4, pp. 334-341, (2000).
B.M. Wilkes, et al., “Simultaneous lowering of serum phosphate and LDL-cholesterol by sevelamer hydrochloride (RenaGel) in dialysis patients,”Clinical Nephrology, vol. 50, No. 6, pp. 381-386, (1998).
“Welchol™ Tablets Package Insert”,Center for Drug Evaluation and Research, Application Number: NDA 21-176, pp. 1-11, and NDA 21-141, pp. 1-11, May 2000.
“Renagel® Package Insert”,GelTex Pharmaceuticals, Inc., Waltham, Massachusetts, 4712 (Jul. 2000), Issued XX/00, pp. 1-10.
Dennis I. Goldberg, et al., “Effect of RenaGel®, non-absorbed, calcium-and aluminium-free phosphate binder, on serum phosphorus, calcium, and intact parathyroid hormone in end-stage renal disease patients,”Nephrol Dial Transplant, 13:2303-2310, (1998).
Glenn M. Chertow, MD, MPH, et al., “Poly [allylamine Hydrochloride] (RenaGel): A Noncalcemic Phosphate Binder for the Treatment of Hyperphosphatemia in Chronic Renal Failure,”American Journal of Kidney Diseases, vol. 29, No. 1, pp. 66-71, (1997).
G.M. Chertow, et al., “A Randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium,”Clinical Nephrology, vol. 51, No. 1, pp. 18-26, (1999).
Anthony J. Bleyer, MD, MS,

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Method for lowering serum glucose does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Method for lowering serum glucose, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for lowering serum glucose will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-3870804

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.