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Claims for Patent: 7,348,361

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Claims for Patent: 7,348,361

Title:Solution for diagnosing or treating tissue pathologies
Abstract:The invention concerns a 5-aminolevulinic acid ester (E-ALA) solution for producing a pharmaceutical preparation useful for diagnosing and/or treating tissue and/or cell pathologies by local radiation exposure using radiation emitted by a light source energy followed, in the case diagnosis, by detection of fluorescent protoporphyrin IX (Pp1X). The E-ALA concentration in the solution is less than 1% and ranges between 0.01% and 0.5%. The low E-ALA concentration in the solution increases Pp1X synthesis and homogenises its distribution in the cell layers while highly reducing the secondary toxicity for the treated cells.
Inventor(s): Marti; Alexandre (Geneva, CH), Lange; Norbert (Lausanne, CH), Zellweger; Matthieu (Lausanne, CH), Wagnieres; Georges (Morges, CH), Van Den Bergh; Hubert (Goumoens-la-Ville, CH), Jichlinski; Patrice (Le Mont-sur-Lausanne, CH), Kucera; Pavel (Lausanne, CH)
Assignee: Ecole Polytechnique Federale de Lausanne (Lausanne, CH)
Application Number:09/673,871
Patent Claims: 1. A pharmaceutical preparation to be administered to a patient for at least one of diagnosis and treatment of tissue or a cell lesion followed by localized irradiation using a beam emitted by a source of light energy, the pharmaceutical preparation comprising: a physiologically acceptable solvent; and ALA hexylester (h-ALA) for generating protoporphyrin IX (PpIX) which is present in the pharmaceutical preparation at a concentration of less than 1% by weight.

2. The pharmaceutical preparation according to claim 1, wherein the ALA hexylester (h-ALA) is dissolved in a solvent which is compatible with a human organism.

3. The pharmaceutical preparation according to claim 2, wherein the solvent is selected from the group consisting of sterilized water, physiological NaCl solution, and a phosphate buffer solution.

4. The pharmaceutical preparation according to claim 2, wherein the pharmaceutical preparation contains a component to adjust the pH of the pharmaceutical preparation to a physiological value ranging from about 4.8 to about 8.1.

5. The pharmaceutical preparation according to claim 1, wherein the pharmaceutical preparation comprises a complementary substance for preventing transformation of the protoporphyrin IX (PpIX) into a heme by iron complexing in the cells.

6. The pharmaceutical preparation according to claim 5, wherein the complementary substance is ethylene diamine tetraacetate (EDTA).

7. The pharmaceutical preparation according to claim 5, wherein the complementary substance is deferoxamine mesylate.

8. The pharmaceutical preparation according to claim 1, wherein the ALA hexylester (h-ALA) is dissolved in a solvent which is compatible with an animal organism.

9. The pharmaceutical preparation according to claim 8, wherein the solvent is selected from the group consisting of sterilized water, physiological NaCl solution, and a phosphate buffer solution.

10. The pharmaceutical preparation according to claim 8, wherein the pharmaceutical preparation contains a component to adjust the pH of the pharmaceutical preparation to a physiological value ranging from about 4.8 to about 8.1.

11. The pharmaceutical preparation according to claim 1, wherein, following administration of the pharmaceutical preparation to the patient and irradiation of the tissue or the cell lesion by the source of light energy, a fluorescence emitted by protoporphyrin IX (PpIX) generated by the ALA hexylester (h-ALA) contained in the pharmaceutical preparation is detected to facilitate diagnosis of the tissue or the cell lesion.

12. A pharmaceutical preparation to be administered to a patient for at least one of diagnosis and treatment of tissue or a cell lesion followed by localized irradiation using a beam emitted by a source of light energy, the pharmaceutical preparation comprising: a physiologically acceptable solvent; ALA hexylester (h-ALA) for generating protoporphyrin IX (PpIX) which is dissolved in the solvent at a concentration of less than 1% by weight; a pH in the range of from about 4.8 to about 8.1; and a complementary substance for preventing transformation of protoporphyrin IX (PpIX) into a heme by iron complexing in live cells, the complementary substance selected from ethylene diamine tetraacetate (BDTA), and deferoxamine mesylate.

13. The pharmaceutical preparation according to claim 12, wherein, following administering the pharmaceutical preparation to the patient and irradiation of the tissue or the cell lesion by the source of light energy, a fluorescence emitted by protoporphyrin IX (PpIX) generated by the ALA hexylester (h-ALA) contained in the pharmaceutical preparation is detected to facilitate diagnosis of the tissue or the cell lesion.

14. A method of diagnosis of a tissue or a cell lesion in an organism, said method comprising: (a) administering to the organism the pharmaceutical preparation of claim 1 (b) irradiating the tissue or the cell lesion with a source of light energy; and (c) detecting fluorescence emitted by protoporphyrin IX (PpIX) generated by the ALA hexylester (h-ALA).

15. The method of claim 14, wherein the concentration of the ALA hexylester (h-ALA) in the pharmaceutical preparation ranges from 0.01% by weight to 0.5% by weight.

16. The method of claim 14, wherein the solvent is selected from the group consisting of sterilized water, physiological NaCl solution, and a phosphate buffer solution.

17. The method of claim 14, wherein the pharmaceutical preparation contains a component to adjust the pH of the pharmaceutical preparation to a physiological value ranging from about 4.8 to about 8.1.

18. The method of claim 14, wherein the pharmaceutical preparation comprises a complementary substance for preventing transformation of the protoporphyrin IX (PpIX) into a heme by iron complexing in the cells.

19. The method of claim 18, wherein the complementary substance is ethylene diamine tetraacetate (EDTA).

20. The method of claim 18, wherein the complementary substance is deferoxamine mesylate.

21. The method of claim 14, wherein the organism is a human or an animal.

22. A method of treatment of a tissue or a cell lesion in an organism, said method comprising: (a) administering to the organism a the pharmaceutical preparation of claim 1; and (b) irradiating the tissue or the cell lesion with a source of light energy.

23. The method of claim 22, wherein the concentration of the ALA hexylester (h-ALA) in the pharmaceutical preparation ranges from 0.01% by weight to 0.5% by weight.

24. The method of claim 22, wherein the solvent is selected from the group consisting of sterilized water, physiological NaCI solution, and a phosphate buffer solution.

25. The method of claim 22, wherein the pharmaceutical preparation contains a component to adjust the pH of the solution to a physiological value ranging from about 4.8 to about 8.1.

26. The method of claim 22, wherein the pharmaceutical preparation comprises a complementary substance for preventing transformation of the protoporphyrin IX (PpIX) into a heme by iron complexing in the cells.

27. The method of claim 26, wherein the complementary substance is ethylene diamine tetraacetate (EDTA).

28. The method of claim 26, wherein the complementary substance is deferoxamine mesylate.

29. The method of claim 22, wherein the organism is a human or an animal.

30. The pharmaceutical preparation of claim 19, wherein the concentration of the ALA hexylester (h-ALA) ranges from 0.01% by weight to 0.5% by weight.

31. The pharmaceutical preparation of claim 12, wherein the concentration of the ALA hexylester (h-ALA) ranges from 0.01% by weight to 0.5% by weight.
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