Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-07-30
2004-12-07
Peselev, Elli (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S025000, C536S017200, C536S017500, C536S018700, C536S123100, C536S124000
Reexamination Certificate
active
06828309
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to the field of pharmacology. More particularly, the invention relates to the treatment of prostate conditions, such as benign prostatic hyperplasia.
2. Summary of the Related Art
Benign prostatic hyperplasia (BPH) is a common disease. The advent of medical therapy for BPH has had a major impact on the practice of urologic care. Gee et al., JURL 160: 1804-1807 (1998), teaches that the overwhelming majority of American urologists use medical therapy first in patients with moderate symptoms.
Currently available medical therapy includes alpha blocking agents, 5-alpha-reductase inhibitors and phytotherapeutic agents. Five-alpha-reductase inhibitors block the conversion of testosterone to dihydrotestosterone (DHT) Moore et al., Euro URL 28: 304-309 (1995) teaches that finasteride, a type II 5-alpha-reductase-inhibitor, produced a 72% decrease in DHT, prostate volume reductions of 30% and a reduction in prostate specific antigen Boyle et al, Urology 48: 398-405 (1996) teaches that the symptomatic response to finasteride is greater in prostates weighing over 40 grams. Carraro et al., Prostate 29: 231-240 (1996) discloses that phytoestrogens provide improvements in uroflow, symptom scores and quality of life nearly equal to that provided by finasteride.
Thus, some progress has been made in noninvasive treatment for BPH. However, the underlying pathology in BPH involves proliferation of smooth muscle cells and increased deposition of extracellular matrix. Thus, there is a need for new treatments that can reduce or eliminate these two factors. Therefore, there remains a need for new therapeutic compositions and methods for treating BPH, as well as chronic prostatitis, prostadynia, and irritative bladder conditions, other than interstitial cystitis. Ideally, such compositions and methods should be orally administered, and should efficaciously and safely treat the designated conditions by causing regression of established lesions and reduction of bladder irritation. In particular, the compositions and methods should treat BPH by reducing the size of the prostate gland and decreasing the associated obstructive symptoms.
BRIEF SUMMARY OF THE INVENTION
The invention relates to the field of pharmacology. More particularly, the invention relates to the treatment of prostate conditions, such as BPH. The invention provides new therapeutic compositions and methods for treating BPH, as well as chronic prostatitis, prostadynia, and irritative bladder conditions, other than interstitial cystitis. The compositions and methods according to the invention reduce or eliminate both smooth muscle cell proliferation and extracellular matrix deposition. The compositions and methods according to the invention, which may be administered orally, efficaciously and safely treat the designated conditions by causing regression of established lesions and reduction of bladder irritation. In particular, the compositions and methods of the invention treat BPH by reducing the size of the prostate gland and decreasing the associated obstructive symptoms.
The present inventor has surprisingly discovered that pentosan polysulfate (PPS, commercially available as Elmiron® from Ivax Corp., Miami, Fla.) can cause regression of scarring and established and proliferative lesions of prostatic tissue.
In one aspect, the invention provides methods for treating prostate conditions. The methods according to the invention comprise administering to a mammal having a condition of the prostate selected from the group consisting of benign prostatic hyperplasia, chronic prostatitis, prostadynia, and an irritative bladder condition, which is other than interstitial cystitis, a treatment effective amount of pentosan polysulfate or a pharmaceutically acceptable salt thereof.
In certain preferred embodiments, the condition of the prostate is benign prostatic hyperplasia. In certain preferred embodiments, the pentosan polysulfate or pharmaceutically acceptable salt thereof is administered orally. In certain preferred embodiments, the treatment effective amount is from about 5 mg/kg to about 30 mg/kg of body weight per day.
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Klarquist & Sparkman, LLP
Lewis Patrick T.
Peselev Elli
The United States of America as represented by the Secretary of
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