Proteolytic extract from bromelain for the treatment of connective tissue disorders
Inventors
Rosenberg, Lior • Rubin, Guy • Asculai, Eilon
Assignees
Publication Number
US-10293033-B2
Publication Date
2019-05-21
Expiration Date
2032-07-19
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Abstract
The present invention relates to a proteolytic extract obtained from bromelain for the treatment of connective tissue diseases. In particular, the present invention relates to a pharmaceutical composition comprising a proteolytic extract obtained from bromelain for the treatment of diseases such as Dupuytren's disease and Peyronie's disease.
Core Innovation
The invention relates to a proteolytic extract obtained from bromelain for the treatment of connective tissue diseases associated with excess collagen deposition, such as Dupuytren's disease and Peyronie's disease. The extract comprises one or more cysteine proteases present in bromelain, including stem bromelain and ananain, and is capable of degrading native, non-denatured collagen.
The problem solved by the invention addresses the limitations of existing treatments for connective tissue diseases involving excess collagen deposition. Current surgical methods like fasciectomy for Dupuytren's disease have complications and high recurrence rates, while non-surgical interventions have limited success and possible side effects. Collagenase treatments, although enzymatic, may damage healthy tissues due to their broad collagen affinity.
This invention unexpectedly discovered that the proteolytic extract selectively degrades diseased collagenous tissue, such as Dupuytren's cords, without damaging healthy connective tissue, providing a safer and more effective enzymatic medicament. The extract can be prepared at high concentrations in small volumes suitable for injection directly into fibrous cords or plaques, reducing extravasation and damage to surrounding tissue, thereby simplifying clinical procedures and improving patient compliance.
Claims Coverage
The patent claims include one independent claim focusing on a method of treating connective tissue diseases using a specific proteolytic extract composition from bromelain. The inventive features involve the composition's components, disease targets, formulation, and administration.
Method of treating connective tissue disease by injection of a proteolytic bromelain extract
A method comprising injecting a pharmaceutical composition containing a therapeutically effective amount of a proteolytic extract obtained from bromelain into a subject, where the extract comprises stem bromelain EC 3.4.22.32, ananain EC 3.4.22.31, at least one cysteine protease precursor, at least one cysteine protease fragment, and a lectin, wherein the disease involves excess collagen deposition, and the injection is repeated multiple times.
Treatment of specific connective tissue diseases
The method targets connective tissue diseases selected from Dupuytren's disease, Peyronie's disease, frozen shoulder, and Ledderhose disease.
Pharmaceutical composition formulation and additives
The pharmaceutical composition may further comprise agents selected from anesthetic agents (e.g., lignocaine and others), antibacterial agents (a broad list including antibiotics and antifungals), and anti-inflammatory agents (non-steroidal and steroidal). It may also include stabilizing agents, antioxidants, preservatives, buffering agents, chelating agents, and tonicity agents, and be formulated as solid, semi-solid, liquid, or foam forms.
Administration into diseased fibrous tissue
The composition is injected directly into the diseased fibrous tissue, such as fibrous nodules or plaques associated with the connective tissue disorders.
Specific composition details and combination with anesthetic agents
The proteolytic extract comprises stem bromelain, ananain, cysteine protease precursors and fragments, and a lectin; in some instances combined with an anesthetic agent such as lignocaine with buffering agents.
The patent claims collectively cover a method involving repeated injections of a defined proteolytic bromelain extract composition for treating connective tissue diseases involving excess collagen, focusing on specific protease components, variety of diseases, pharmaceutical compositions with optional additives, and direct injection into affected fibrous tissue.
Stated Advantages
The proteolytic extract specifically degrades diseased fibrous tissue with excess collagen while sparing healthy connective tissue, offering a safer treatment compared to collagenase.
High concentrations of proteolytic extract can be prepared in small volumes suitable for injection, reducing procedure complexity and improving patient compliance.
The proteolytic extract showed equal or superior efficacy to collagenase in dissolving pathological cords, with a reduced risk of collateral tissue damage.
Documented Applications
Treatment of connective tissue diseases associated with excess collagen deposition, specifically Dupuytren's disease and Peyronie's disease.
Treatment of fibrous tissue malformations and abnormalities including frozen shoulder and Ledderhose disease.
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