Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1997-01-03
1998-12-22
Robinson, Douglas W.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
536 552, 536103, 5361231, 536124, A61K 31715, C08B 3700
Patent
active
058520031
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to the use of polymers or biopolymers for the preparation of a drug for treating lesions of all origins affecting the skeletal muscle or the cardiac muscle in human or veterinary medicine and pharmaceutical compositions for this treatment.
BACKGROUND
The synthesis of CMDBS polymers (dextrans substituted by carboxymethyl, benzylamine and sulfonate) has been described in French Patent 2461724 and U.S. Pat. No. 4,740,594. Some of these polymers mimic heparin and may be used as plasma heparin replacement products, thanks to their anticoagulant and anticomplement properties.
Some of these CMDBS polymers mimic another property of heparin consisting of a stabilization, protection and potentialization of the in vitro biological activity of the growth factors of the FGF family (Tardieu and coll., Journal of Cellular Physiology, 1992, 150, pp. 194 to 203).
French Patent 2 644.066 describes the use of certain CMDBSs associated with FGFs for healing the skin and the cornea. Experiments have been conducted by provoking a cutaneous wound with the help of a hollow punch 6 mm in diameter in the rat. In this example, the CMDBS associated with the FGF 2 makes it possible to obtain a definite effect on the speed and the quality of skin repair.
Another biopolymer, dextran sulfate, has also been advanced in association with FGFS, as a stabilizer and protector, in Japanese Patent No. 13890. Dextran sulfate, moreover, is widely used in skin healing ointments and creams as well as in collyrium compositions, but, to the knowledge of the applicant, has no reported effect on the healing and regeneration of muscular lesions.
Another agent, sucrose sulfate ester and its aluminum salt, sucralfate, are products described and used, on their own or associated with FGFs, as agents in the treatment of ulcers and lesions of the digestive tract (U.S. Pat. No. 3,432,489 and U.S. Pat. No. 5,202,311).
The skeletal and/or cardiac muscular tissues are particularly rich in growth factors and several authors have described the presence and/or action of FGFs and beta TGFs in and on myoblastic cells (e.g. D. Gospodarowicz and Cheng, In Vitro Cellular and Developmental Biology 1987 23(7): pp. 507-514; Groux-Muscatelli B., Bassaglia Y., Barritault D., Caruelle J. P. and Gautron J., Dev. Biol. 1990, 142: pp. 380-385; Johnson S. and Allen R., Exp. Cell Res. 1990, 187: pp 250-254; Dayton W. and Hathaway M., Poult Sci 1991 70: pp 1815-1822) as well as their extraction from skeletal or cardiac muscles (e.g. Morrow and coll., J. Clin. Invest. 1990, 85: pp 1816-1820; Padua R. and E. Kardami, Growth Factor 1993, 8: pp 291-306; Parker T. and Scheinder M., Annu. Rev. Physiol., 1991, 53: pp 179-200; Casscells W. and coll., Ann. N.Y. Acad. Sci. 1990, 593: pp. 148-161).
The healing action of FGFs in cardiac muscle lesions induced by ischemia creation has been described (Yanagisawa-Miwa and coll., Science 1992, 257: pp 1401-1403).
Franco (U.S. Pat. No. 4,378,347) has also described the use of an FGF, particularly in the treatment of cardiac ischemias. Dextran beads are used as excipient in certain formulations described in this patent.
The activity of the composition is very clearly attributable to the FGF.
An analysis of the prior art therefore reveals that polymers have already been used in association with growth factors.
However, none of the polymers in the documents cited above present effects on their own, that is to say without being associated with growth factors.
Moreover, the activity of polymer-factor associations has been described only on certain lesions of a particular tissue type, namely cutaneous tissue.
Due to the unpredictable nature of the therapeutic effects of a given molecule, it was not clear whether these polymers could have an effect on tissues other than those of the skin.
It is, in fact, well known that the different tissues of the human or animal body present structural and functional specific features making it impossible to predict the effect of a molecule, known for its effect on the cut
REFERENCES:
J. Biomater. Sci. Polym. Ed., vol. 3, No. 2, issued 1991, Avramoglou et al, pp. 149-154.
Barritault Denis
Caruelle Jean-Pierre
Desgranges Pascal
Gautron Jean
Meddahi Anne
Robinson Douglas W.
Societe Valbiofrance
White Everett
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