Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Monoclonal antibody or fragment thereof
Patent
1996-11-12
1999-10-26
Caputa, Anthony C.
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Monoclonal antibody or fragment thereof
530395, 5303871, 5303881, 53038823, 5303892, 4241451, 4241581, A61K 39395, C07K 1618, C07K 1622
Patent
active
059723351
DESCRIPTION:
BRIEF SUMMARY
The present invention concerns compositions for promoting the healing of wounds or fibrotic disorders.
At present there is a lack of compositions for treating wounds or fibrotic disorders.
By "wounds or fibrotic disorders" is meant any condition which may result in the formation of scar tissue. In particular, this includes the healing of skin wounds, the repair of tendon damage, the healing of crush injuries, the healing of central nervous system (CNS) injuries, conditions which result in the formation of scar tissue in the CNS, scar tissue formation resulting from strokes, and tissue adhesion, for example, as a result of injury or surgery (this may apply to e.g. tendon healing and abdominal strictures and adhesions). Examples of fibrotic disorders include pulmonary fibrosis, glomerulonephritis and cirrhois of the liver, in which TGF-.beta..sub.1 has been implicated and proliferative vitreoretinopathy, in which TGF-.beta..sub.2 has been implicated.
In particular, there is a lack of compositions for promoting the healing of wounds or fibrotic disorders with reduced scarring. Scar tissue formation, although providing mechanical strength to a healed wound, can be unsightly and may impair the function of the tissue.
This is particularly the case in wounds which result in scar tissue formation in the CNS, the scar tissue inhibiting the reconnection of severed or re-growing nerve ends, so significantly affecting their function.
There is also a lack of compositions for use in the treatment of chronic wounds, for example venous ulcers, diabetic ulcers and bed sores (decubitus ulcers), especially in the elderly and wheel chair bound patients. Such compositions may be extremely useful in patients where wound healing is either slow or in whom the wound healing process has not yet started. Such compositions may be used to "kick-start" wound healing and may then be used in combination with compositions (e.g. those of PCT/GB93/00586) which promote the healing of wounds or fibrotic disorders with reduced scarring. Hence not only may a chronic wound be healed, but it may be healed with reduced scarring.
WO 92/17206 discloses compositions for use in the treatment of wounds to inhibit scar tissue formation during healing, comprising an effective activity-inhibiting amount of a growth factor neutralising agent or agents specific against only fibrotic growth factors together with a pharmaceutically acceptable carrier.
WO 93/19769 discloses a healing composition containing at least one non-fibrotic growth factor in combination with a pharmaceutically acceptable carrier.
These publications disclose the use of antibodies to TGF-.beta..sub.1, TGF-.beta..sub.2 and PDGF; binding proteins which prevent TGF-.beta..sub.1, TGF-.beta..sub.2 and PDGF from binding to their receptors by binding to the proteins or their receptors; soluble forms of the growth factor receptor or the growth factor binding domains of the receptors; and antisense oligonucleotides or ribosymes which act to prevent fibrotic growth factor mRNA translation.
Surprising results have now been obtained by the present inventors using antibodies specific to growth factors and proteins associated therewith.
According to the present invention there is provided a composition for promoting the healing of wounds or fibrotic disorders comprising at least one agent specific to either a growth factor or a protein associated therewith in a system and which affects the quantity of active growth factor in the system, in combination with a pharmaceutically acceptable carrier, diluent or excipient.
By "agent" is meant any compound or molecule which is capable of affecting the quantity of active growth factor in a system. Such an agent may work by neutralising, activating or deactivating a growth factor, affecting its half-life or by causing a change in its production level.
By "system" is meant the system to which the composition is applied and as such is defined by both the nature of the wound or fibrotic disorder and by the method of application of the composition. For example, in t
REFERENCES:
Shah et al: "Control of scarring in adult wounds by neutralizing antibody to transforming growth factor beta", The Llancet, vol. 339, No. 8787, Jan. 25, 1992, pp. 213 214.
Barcellos-Hoffet al: "Transforming growth factor-beta activation in irradiated murine mammary gland", The Journal Of Clinical Investigation, vol. 92, No.2 Feb. 1994, pp. 892-899.
Shah et al: "Neutralising antibody to TGF-betal, 2 reduces cutaneous scarring in adult rodent", Journal Of Cell Science, vol. 107, No. 5 May 1994, pp. 1137-1157.
Shah et al: "Neutralisation of TGG-betal and TGF-beta2 or exogenous addition of TGF-beta3 to cutaneous rat wounds reduces scarring", Journal Of Cell Science, vol. 108, No. 3, Mar. 1995, pp. 985-1002.
Adzick et al: "Cells, matrix, growth factors, and the surgeon", Annals Of Surgery, vol. 220, No.1,JUL. 1994, pp. 10-18.
Ferguson Mark William James
Shah Mamta
Bansal Geetha P.
Caputa Anthony C.
The Victoria University of Manchester
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