US20060204488A1 - Methods for treating adhesive capsulitis - Google Patents

Methods for treating adhesive capsulitis Download PDF

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Publication number
US20060204488A1
US20060204488A1 US11/335,157 US33515706A US2006204488A1 US 20060204488 A1 US20060204488 A1 US 20060204488A1 US 33515706 A US33515706 A US 33515706A US 2006204488 A1 US2006204488 A1 US 2006204488A1
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Prior art keywords
placebo
collagenase
baseline
shoulder
degrees
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US11/335,157
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English (en)
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Marie Badalamente
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Research Foundation of State University of New York
Biospecifics Technologies LLC
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Individual
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Priority to US11/335,157 priority Critical patent/US20060204488A1/en
Assigned to ADVANCE BIOFACTURES CORPORATION reassignment ADVANCE BIOFACTURES CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BADALAMENTE, MARIE A.
Publication of US20060204488A1 publication Critical patent/US20060204488A1/en
Assigned to RESEARCH FOUNDATION OF THE STATE UNIVERSITY OF NEW YORK AT STONY BROOK reassignment RESEARCH FOUNDATION OF THE STATE UNIVERSITY OF NEW YORK AT STONY BROOK ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BIOSPECIFICS TECHNOLOGIES CORP.
Priority to US12/115,256 priority patent/US7854929B2/en
Assigned to NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT reassignment NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT CONFIRMATORY LICENSE (SEE DOCUMENT FOR DETAILS). Assignors: THE RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK
Priority to US12/266,090 priority patent/US8323643B2/en
Assigned to BIOSPECIFICS TECHNOLOGIES CORP. reassignment BIOSPECIFICS TECHNOLOGIES CORP. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ADVANCE BIOFACTURES CORPORATION
Priority to US13/688,387 priority patent/US20130330320A1/en
Priority to US14/572,104 priority patent/US20150174216A1/en
Priority to US15/173,497 priority patent/US20160354450A1/en
Assigned to UNITED STATES PATENT AND TRADEMARK OFFICE reassignment UNITED STATES PATENT AND TRADEMARK OFFICE CONFIRMATORY LICENSE (SEE DOCUMENT FOR DETAILS). Assignors: THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24007—Interstitial collagenase (3.4.24.7), i.e. matrix metalloprotease 1 or MMP1

Definitions

  • Adhesive capsulitis (frozen shoulder) is a clinical syndrome of severe pain and significantly decreased shoulder motion which may occur idiopathically, after trauma or affect patients with diabetes and/or thyroid disorders. The duration of the disorder may be from months to years and severely affect the quality of life. Lengthy physical therapy, sometimes including cortisone injections and/or manipulation under anesthesia and/or shoulder arthroscopy, currently are the standards of orthopedic care. However, more effective therapies are needed.
  • the invention relates to the discovery that collagenase injections are effective in lyse the collagenous adhesions in the shoulder capsule and treat the disorder, adhesive capsulitis.
  • the invention relates to methods of treating or preventing adhesive capsulitis, or frozen shoulder, in a subject in need of such treatment comprising injecting or otherwise delivering an effective amount of collagenase to the collagenous adhesions in the shoulder.
  • the invention also relates to the use of collagenase in the manufacture of a medicament to treat adhesive capsulitis.
  • FIG. 1 is a bar graph that reports the improved mobility, or active elevation, in twelve patients who received a third collagenase injection.
  • FIG. 2 is a line graph of the means of normal shoulder motion vs. collagenase dose groups.
  • FIG. 3 is a line graph of the means of shoulder motion after a 0.58 open label collagenase injection.
  • FIGS. 4 A- 4 EE are line and bar graphs depicting the data obtained in the clinical trial described herein.
  • the invention relates to the discovery that collagenase injections are effective in lyse the collagenous adhesions in the shoulder capsule and treat the disorder, adhesive capsulitis.
  • the invention relates to methods of treating or preventing adhesive capsulitis, or frozen shoulder, in a subject in need of such treatment comprising injecting or otherwise delivering an effective amount of collagenase to the collagenous adhesions in the shoulder capsule.
  • the invention also relates to the use of collagenase in the manufacture of a medicament to treat adhesive capsulitis.
  • Collagenase injections have been proposed for the treatment of diseases such as Duptyren's disease and Peyronie's disease. Both diseases are associated with collagen plaques or cords. Wegman, Thomas L., U.S. Pat. No. 5,589,171, Dec. 31, 1996, U.S. Pat. No. 6,086,872, Jul. 11, 2000 and U.S. Pat. No. 6,022,539, Feb. 8, 2000, which are incorporated herein by reference.
  • Collagenase is an enzyme that has the specific ability to digest collagen.
  • a preferred form of collagenase is derived from fermentation by Clostridium histolyticum, and is purified by a chromatographic technique.
  • Sterilized lyophilized collagenase powder is commercially available having a minimum assay of 50 ABC units per mg.
  • the assay may range considerably above that from batch to batch, but is taken into account in determining the weight of powder to use with a pharmaceutically acceptable carrier, e.g. normal saline, in preparing a desired concentration for treatment.
  • a preferred collagenase composition comprising a mixture of collagenase I and collagenase II in a mass ratio of about 1 to 1 and having specific activity of at least about 700 SRC units/mg, such as at least about 1000 SRC units/mg, more preferably at least about 1500 SRC units/mg.
  • One SRC unit will solubilize rat tail collagen into ninhydrin reaction material equivalent to 1 nanomole of leucine per minute, at 25° C., pH 7.4.
  • Collagenase has been described in ABC units as well. This potency assay of collagenase is based on the digestion of undenatured collagen (from bovine tendon) at pH 7.2 and 37 degrees C. for 20-24 hours.
  • the collagenase is preferably administered via injection in a liquid carrier that is pharmaceutically acceptable.
  • a liquid carrier that is pharmaceutically acceptable.
  • the carrier does not interact or deactivate the collagenase.
  • examples are normal saline, aqueous NaCl/CaCl2 buffer (e.g., containing 0.9% NaCl and 2 mM CaCl 2 ), aqueous dextran solution, and aqueous hetastarch solution.
  • the lyophilized formulation can contain 0.1 mg lactose monohydrate per 1,000 ABC units.
  • Each glass vial used below contained 5,150 ABC units of enzyme.
  • collagenase in a liquid carrier is injected into a collagen adhesion within the shoulder capsule.
  • the amount and concentration of collagenase used are effective to soften and relax or rupture the adhesion.
  • the total volume of liquid injected preferably does not exceed about 0.50 ml. A smaller volume down to about 0.25 ml to about 0.1 ml is usually more preferred.
  • the injection is a sterile one given between the interval of the deltoid and pectoral muscles.
  • An anesthesia injection of 5-10 ml sterile 1% lidocaine preferably precedes the collagenase injection for the comfort of the patient.
  • the total dosage is preferably injected in one portion, although two or more portions at the same or different points into the shoulder capsule are possible, preferably intralesionally, or intra-adhesionally.
  • the objective of these procedures is to assure good distribution of the collagenase within a small volume of the adhesion.
  • the patient wears a sling to immobilize the shoulder for approximately 5-6 hours post injection. Patients perform at home physical therapy for at least one month to assist in the return of normal range of shoulder motion.
  • the collagenase can be administered locally and topically (e.g., via a transdermal patch or topical cream or ointment), preferably at site proximal to the affected shoulder or can be administered via an implant (e.g., microcapsules or microspheres which release the collagenase over time).
  • an implant e.g., microcapsules or microspheres which release the collagenase over time.
  • the subject can be any animal, preferably a mammal or human patient.
  • animals that can be treated according to the invention include domestic animals (such as cats, dogs, etc.), farm animals (such as horses, cows, pigs, etc.) and exotic animals (such as monkeys, apes, etc.).
  • Preferred human patients are those that have decreased shoulder motion which occurred idiopathically, after trauma or patients with diabetes and/or thyroid disorders.
  • the patient is characterized as having extremely decreased shoulder motion in all planes to include active elevation, active internal rotations (spine level reached by the thumb behind the back), active external rotation, passive elevation, passive external rotation at the side, passive external rotation at 90 degrees, function scores. Pain is increased to a level where it interferes with activities of daily living and diminishes the quality of life.
  • the invention can achieve improvement in all planes of motion of the shoulder or decreased pain or alleviation of another symptom of the disorder.
  • n 7, 7, 4, and 6 for, respectively, placebo, 2,500 unit, 5000 unit, and 10,000 unit treatment groups.
  • n 10, 8, 8, and 8 for, respectively, placebo, 2,500 unit, 5000 unit, and 10,000 unit treatment groups.
  • n 4, 5, 3, and 5 for, respectively, placebo, 2,500 unit, 5000 unit, and 10,000 unit treatment groups for subjects with contralateral shoulder measurements at baseline.
  • Three subjects in the data received had data for a third.
  • protocol-defined success criteria None of the outcome measures approached statistical significance for any active treatment compared to placebo.
  • the protocol-defined success criteria drawn from published standards, are too strict for the population in this study. Comparison of the contralateral shoulder means to the published standards seems to not support that.
  • the protocol-defined criteria for active elevation and active internal rotation (spine level) are 160 degrees and 10 degrees, respectively, but, from Table 1, the subjects in this study had better functionality at baseline in the contralateral shoulder for these two outcome measures than the published standards stipulate.
  • the protocol also stipulates a more sensitive analysis of the data using the analysis of covariance and that approach does provide evidence that collagenase had activity in this study.
  • Adverse events were local and minimal consisting of injection area tenderness and biceps ecchymosis. These resolved well in 7-14 days. There were no adverse immune events.
  • Open-label study phase Randomization Mean change Treatment cycle treatment arm n from baseline p-value 2 0 (Placebo) 13 20.6 ⁇ .0001 2 2,500 12 21.0 ⁇ .0001 2 5,000 9 18.4 0.0006 2 10,000 10 21.6 ⁇ .0001 3 0 (Placebo) 7 22.7 0.0037 3 2,500 7 23.1 ⁇ .0001 3 5,000 4 15.8 0.1151 3 10,000 6 27.5 0.0002

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • General Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Adhesives Or Adhesive Processes (AREA)
US11/335,157 2005-01-21 2006-01-19 Methods for treating adhesive capsulitis Abandoned US20060204488A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US11/335,157 US20060204488A1 (en) 2005-01-21 2006-01-19 Methods for treating adhesive capsulitis
US12/115,256 US7854929B2 (en) 2005-01-21 2008-05-05 Method for treating lateral epicondylitis using collagenase
US12/266,090 US8323643B2 (en) 2005-01-21 2008-11-06 Methods for treating adhesive capsulitis
US13/688,387 US20130330320A1 (en) 2005-01-21 2012-11-29 Methods for Treating Adhesive Capsulitis
US14/572,104 US20150174216A1 (en) 2005-01-21 2014-12-16 Methods for Treating Adhesive Capsulitis
US15/173,497 US20160354450A1 (en) 2005-01-21 2016-06-03 Method for Treating Adhesive Capsulitis

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US64577205P 2005-01-21 2005-01-21
US67744005P 2005-05-03 2005-05-03
US71947005P 2005-09-22 2005-09-22
US11/335,157 US20060204488A1 (en) 2005-01-21 2006-01-19 Methods for treating adhesive capsulitis

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US11/703,269 Continuation-In-Part US20070224184A1 (en) 2005-01-21 2007-02-07 Method for treating cellulite
US12/266,090 Continuation US8323643B2 (en) 2005-01-21 2008-11-06 Methods for treating adhesive capsulitis

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US11/335,157 Abandoned US20060204488A1 (en) 2005-01-21 2006-01-19 Methods for treating adhesive capsulitis
US12/266,090 Active 2027-11-17 US8323643B2 (en) 2005-01-21 2008-11-06 Methods for treating adhesive capsulitis
US13/688,387 Abandoned US20130330320A1 (en) 2005-01-21 2012-11-29 Methods for Treating Adhesive Capsulitis
US14/572,104 Abandoned US20150174216A1 (en) 2005-01-21 2014-12-16 Methods for Treating Adhesive Capsulitis
US15/173,497 Abandoned US20160354450A1 (en) 2005-01-21 2016-06-03 Method for Treating Adhesive Capsulitis

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US13/688,387 Abandoned US20130330320A1 (en) 2005-01-21 2012-11-29 Methods for Treating Adhesive Capsulitis
US14/572,104 Abandoned US20150174216A1 (en) 2005-01-21 2014-12-16 Methods for Treating Adhesive Capsulitis
US15/173,497 Abandoned US20160354450A1 (en) 2005-01-21 2016-06-03 Method for Treating Adhesive Capsulitis

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AU (1) AU2006206393B2 (pl)
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CA (1) CA2593038C (pl)
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US20070224184A1 (en) * 2006-02-22 2007-09-27 The Research Foundation Of The State University Of New York Method for treating cellulite
US20070224183A1 (en) * 2006-01-30 2007-09-27 Sabatino Gregory L Compositions and methods for treating collagen-mediated diseases
US7824673B2 (en) 1994-12-15 2010-11-02 Advance Biofactures Corporation Reduction of adipose tissue
WO2013034416A1 (en) 2011-09-09 2013-03-14 Unilever N.V. Antimicrobial method and composition
US9636385B2 (en) 2012-10-24 2017-05-02 The Research Foundation For The State University Of New York Use of collagenase to treat glaucoma
US10071143B1 (en) 2007-05-03 2018-09-11 The Research Foundation For The State University Of New York Methods for non-surgical treatment of carpal tunnel syndrome
US11123280B2 (en) 2017-03-01 2021-09-21 Endo Ventures Limited Method of assessing and treating cellulite
US11473074B2 (en) 2017-03-28 2022-10-18 Endo Global Aesthetics Limited Method of producing collagenase
US11879141B2 (en) 2012-01-12 2024-01-23 Endo Global Ventures Nucleic acid molecules encoding clostridium histolyticum collagenase II and methods of producing the same

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US8323642B2 (en) * 2006-12-13 2012-12-04 Depuy Mitek, Inc. Tissue fusion method using collagenase for repair of soft tissue
EP2274422B1 (en) * 2008-04-17 2017-03-15 Anaeropharma Science, Inc. Expression vector
WO2012056044A1 (en) * 2010-10-30 2012-05-03 Imperial Innovations Ltd Treatment for dupuytren's disease
RU2745328C1 (ru) * 2020-05-24 2021-03-23 Федеральное государственное бюджетное учреждение «Федеральный центр травматологии, ортопедии и эндопротезирования» Министерства здравоохранения и социального развития РФ (г. Чебоксары) Способ лечения болевого синдрома при адгезивном капсулите

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Cited By (26)

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US7824673B2 (en) 1994-12-15 2010-11-02 Advance Biofactures Corporation Reduction of adipose tissue
US20110243919A1 (en) * 2006-01-30 2011-10-06 Sabatino Gregory L Compositions and Methods for Treating Collagen-Mediated Diseases
US20100330065A1 (en) * 2006-01-30 2010-12-30 Sabatino Gregory L Compositions and methods for treating collagen-mediated diseases
US20110189163A1 (en) * 2006-01-30 2011-08-04 Sabatino Gregory L Compositions and Methods for Treating Collagen-Mediated Diseases
US20070224183A1 (en) * 2006-01-30 2007-09-27 Sabatino Gregory L Compositions and methods for treating collagen-mediated diseases
US20140004094A1 (en) * 2006-01-30 2014-01-02 Gregory L. Sabatino Compositions and methods for treating collagen-mediated diseases
US20110158972A1 (en) * 2006-01-30 2011-06-30 Sabatino Gregory L Compositions and methods for treating collagen-mediated diseases
US20110189153A1 (en) * 2006-01-30 2011-08-04 Sabatino Gregory L Compositions and Methods for Treating Collagen-Mediated Diseases
US20170087229A1 (en) * 2006-01-30 2017-03-30 Auxilium US Holdings, Inc. Compositions and methods for treating collagen-mediated diseases
US20110243908A1 (en) * 2006-01-30 2011-10-06 Sabatino Gregory L Compositions and Methods for Treating Collagen-Mediated Diseases
US20110243909A1 (en) * 2006-01-30 2011-10-06 Sabatino Gregory L Compositions and Methods for Treating Collagen-Mediated Diseases
US20110243920A1 (en) * 2006-01-30 2011-10-06 Sabatino Gregory L Compositions and methods for treating collagen-mediated diseases
US20100233151A1 (en) * 2006-01-30 2010-09-16 Sabatino Gregory L Compositions and methods for treating collagen-mediated diseases
US7811560B2 (en) * 2006-01-30 2010-10-12 Auxilium Us Holdings, Llc Compositions and methods for treating collagen-mediated diseases
US20070224184A1 (en) * 2006-02-22 2007-09-27 The Research Foundation Of The State University Of New York Method for treating cellulite
US10123959B2 (en) * 2006-02-22 2018-11-13 The Research Foundation For The State University Of New York Methods for treating cellulite
US20190053995A1 (en) * 2006-02-22 2019-02-21 The Research Foundation For The State University Of New York Methods for Treating Cellulite
US20220249348A1 (en) * 2006-02-22 2022-08-11 The Research Foundation For The State University Of New York Methods for treating cellulite
US10071143B1 (en) 2007-05-03 2018-09-11 The Research Foundation For The State University Of New York Methods for non-surgical treatment of carpal tunnel syndrome
WO2013034416A1 (en) 2011-09-09 2013-03-14 Unilever N.V. Antimicrobial method and composition
US11879141B2 (en) 2012-01-12 2024-01-23 Endo Global Ventures Nucleic acid molecules encoding clostridium histolyticum collagenase II and methods of producing the same
US11975054B2 (en) 2012-01-12 2024-05-07 Endo Global Ventures Nucleic acid molecules encoding clostridium histolyticum collagenase I and methods of producing the same
US9636385B2 (en) 2012-10-24 2017-05-02 The Research Foundation For The State University Of New York Use of collagenase to treat glaucoma
US11123280B2 (en) 2017-03-01 2021-09-21 Endo Ventures Limited Method of assessing and treating cellulite
US11813347B2 (en) 2017-03-01 2023-11-14 Endo Ventures Limited Method of assessing and treating cellulite
US11473074B2 (en) 2017-03-28 2022-10-18 Endo Global Aesthetics Limited Method of producing collagenase

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US20150174216A1 (en) 2015-06-25
CN101107006B (zh) 2013-09-11
JP2008528498A (ja) 2008-07-31
DK1846022T3 (en) 2015-08-24
HK1221143A1 (zh) 2017-05-26
US20160354450A1 (en) 2016-12-08
WO2006078870A2 (en) 2006-07-27
EP1846022A2 (en) 2007-10-24
EP1846022A4 (en) 2009-08-05
BRPI0607280A2 (pt) 2009-08-25
US20090123454A1 (en) 2009-05-14
PL1846022T3 (pl) 2016-06-30
JP4967081B2 (ja) 2012-07-04
KR100989267B1 (ko) 2010-10-20
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