Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1999-01-27
1999-12-07
Henley, III, Raymond
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
A61K 3800
Patent
active
059983647
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to the use of Component B as cicatrizant, in particular in the treatment of wounds, ulcers and other traumatic lesions to any of the tissues in the body.
Component B is a 81-amino acid protein originally isolated from human urine. The human gene has been cloned and expressed in CHO cells as recombinant human Component B. The molecule has a molecular weight of about 8.9 kD. It has been thoroughly described in WO 94/14259.
Such protein contains ten cysteines and bears a motif typical of serine protease enzymes. Sequence alignment to a protein data bank has shown some homologies of Component B with known molecules such as CD59, urokinase receptor (uPA-R) and some venom toxins.
Data obtained by the Applicant from the study of organ and tissue distribution in mice showed that eye, lung and skin are the sites in which Component B RNA is mainly expressed. In human tissues, Component B was found to be highly expressed in the squamous epithelia and mucosae, such as skin, oesophagus and exocervix, as determined by immunohistochemistry. Finally, EGF has been found to induce the expression of Component B RNA in human squamous epidermoid A431 cells.
Component B has been reported to have antiinflammatory, anticoagulant and antitumoral activity, as well as an activity as inihibitor of the binding of TGF-.alpha. to its receptor.
The Applicant has now found that Component B is also useful as cicatrizant, and it is, therefore, in particular, useful in the treatment of wounds, ulcers and other traumatic lesions to any of the tissues in the body.
Therefore, the main object of the present invention is the use of Component B for the manufacture of a pharmaceutical composition useful as cicatrizant, in particular in the treatment of wounds, ulcers and other traumatic lesions to any of the tissues in the body.
A further object of this invention is a method of treatment of wounds, ulcers and other traumatic lesions to any of the tissues in the body, comprising administering an effective amount of Component B, together with a pharmaceutically acceptable excipient.
Another object of the invention are pharmaceutical compositions prepared as described above.
For the methods of preparation of Component B and for its amino acid sequence, reference is made to the disclosure of WO 94/14259.
The administration of the active ingredient may be by oral, intravenous, intramuscular, subcutaneous or topical route. Other routes of administration, which may establish the desired blood levels of the respective ingredients, are comprised by the present invention.
For the human therapy the preferred doses are 1 mg/kg or less for the systemic administration and 4 .mu.g/cm.sup.2 or less for the topical administration.
The invention will now be described by means of the following Examples, which should not be construed as in any way limiting the present invention. The Examples will refer to the Figures as specified here below.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1: the effect of the intravenous administration of Component B in comparison with that of betametasone (Bentelan.RTM.) on the experimental wound healing is shown. In particular, the results of Experiment 1 are summarised. Test drugs were administered daily for 6 consecutive days from day 0 (the day of wound induction) through 5.
FIG. 2: the effect of the intravenous administration of Component B (batch 004-001b) in comparison with that of betametasone (Bentelan.RTM.) on the experimental wound healing is shown. In particular, the results of Experiment 2 are summarised. Test drugs were administered daily for 6 consecutive days from day 0 (the day of wound induction) through 5.
FIG. 3: the effect of the topical application of Component B (batch 004-001) on the experimental wound healing is shown. In particular, the results of Experiment 3 are summarised. Test drugs were topically applied for 5 consecutive days from day 0 (the day of wound induction) through 4.
FIG. 4: the effect of the topical application of bovine serum albumin on the experimental wound healing
Borrelli Francesco
Donini Silvia
Martelli Fabrizio
Mastrangeli Renato
Applied Research Systems ARS Holding N.V.
Henley III Raymond
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