Processing

Please wait...

Settings

Settings

Goto Application

1. WO2020136272 - KIT FOR INHALED CHEMOTHERAPY, AND TREATMENT OF LUNG CANCER WITH SAID KIT

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

[ EN ]

CLAIMS

1 . Ki† for an inhaled chemotherapy comprising:

a) a series of single hermetically packaged therapeutic doses of a dry powder for inhalation containing at least one anti neoplastic agent chosen in the group of platinum drugs such as carboplatin, cisplatin, oxaliplatin, or nedaplatin with a lipid matrix and optionally one or more excipient, such as a PEGylated excipient and/or a carrier

b) a series of disposable dry powder inhaler devices, wherein

i) each single hermetically packaged therapeutic dose having a close state and an open state, ii) each disposable dry powder inhaler device having a close position and optionally an open position,

iii) each single hermetically packaged therapeutic dose being provided for being accommodated in said close state in one disposable dry powder inhaler device of said series of disposable dry powder inhaler devices,

iv) and each single disposable dry powder inhaler device is provided to be in said close position before or once each single hermetically packaged therapeutic dose become in said open state.

2. Kit for an inhaled chemotherapy according to claim 1 , wherein said single hermetically packaged therapeutic dose is a capsule or a blister.

3. Kit for a inhaled chemotherapy according to any of the claims 1 to 2, wherein the lipid matrix is a matrix of pure or a mixture of triglycerides, such as for example tristearin, hydrogenated vegetal oil (e.g. hydrogenated castor oil) or any hydrophobic glyceride derivative having values of Log P higher than 5, preferably comprised between 14 and 25, more particularly between 18 and 25 and preferably around 20, as measured using the shake-flask method.

4. Kit for an inhaled chemotherapy according to any of the claims 1 to 3, wherein the PEGylated excipient is derived from

vitamin E or from phospholipids, such as focopheryl polyethylene glycol succinate (TPGS) or disfearoyl phosphoefhanolamine polyethylene glycol 2000 (DSPE-m PEG-2000) .

5. Ki† for a inhaled chemotherapy according†o any of the claims 1 †o 4, wherein each disposable dry powder inhaler device comprises a dispersion chamber in fluid connection with an inhalation channel and connected †o a loading chamber for accommodating said single hermetically packaged therapeutic dose inside said disposable dry powder inhaler device, said loading chamber comprising activation means having an activated position and a res† position, said activated position being provided †o open said single hermetically packaged therapeutic dose and locking means provided †o prevent extraction of the single hermetically packaged therapeutic dose once said activation means have been moved†o said activated position.

6. Ki† for a inhaled chemotherapy according†o any of the claims 1 †o 4, wherein each disposable dry powder inhaler device comprises a dispersion chamber in fluid connection with an inhalation channel and connected †o a loading chamber for accommodating said single hermetically packaged therapeutic dose inside said disposable dry powder inhaler device, said loading chamber comprising activation means having an activated position and a res† position, said activated position being provided †o open said single hermetically packaged therapeutic dose and locking means having an open position and a lock position provided†o prevent extraction of the single hermetically packaged therapeutic dose, said activation means being provided†o be able†o be moved†o said activated position only when said locking means are in said lock position .

7. Ki† for a inhaled chemotherapy according†o any of the claims 1 †o 4, wherein each disposable dry powder inhaler device comprises a dispersion chamber in fluid connection with an inhalation channel and connected †o a loading chamber for accommodating said single hermetically packaged therapeutic dose inside said disposable dry powder inhaler device, said loading chamber comprising activation means having an activated position and a res† position, said disposable dry powder inhaler device comprising closing means provided †o isolate the outside environment from the inside of the disposable dry powder inhaler device, in particular by closing the inhalation channel.

8. Kit for an inhaled chemotherapy according†o any of the claims 1 †o 7, wherein said disposable dry powder inhaler device is ready†o use and comprises a dispersion chamber in fluid connection with an inhalation channel and connected †o a loading chamber comprising said single hermetically packaged therapeutic dose inside said disposable dry powder inhaler device.

9. Kit for a inhaled chemotherapy according†o any of the claims 1†o 8, wherein said single hermetically packaged therapeutic dose comprises a therapeutic dose in the form of a dry and fine powder having a geometric particle size distribution (PSD) dso lower than or equal †o 30 miti, preferably lower than 15 miti, preferably lower than or equal†o 10 miti, preferably lower than or equal†o 5 miti, and a geometric particle size distribution (PSD) d9o lower than or equal†o 60 miti, preferably lower than or equal†o 30 miti, more preferably lower than or equal†o 15 miti, preferably lower than or equal†o 10 miti and more preferably lower than or equal†o 7 miti, and optionally a volume mean diameter D[4,3] lower than or equal†o 40 miti, preferably lower than or equal†o 20 miti, more preferably lower than or equal†o 15 miti, preferably lower than or equal †o 10 miti, preferably lower than or equal†o 6 miti

10. Kif for an inhaled chemotherapy according†o any of the claims 1 †o 9, wherein each single hermetically packaged therapeutic dose comprises a total powder weigh† content between 2 †o 100 mg, preferably between 3 and 80 mg, more preferably between 4 and 60 mg, in particular between 5 and 50 mg, such as for example between 6 and 20, or between 7 and 15, like around 10 mg.

1 1 . Ki† for an inhaled chemotherapy according†o any of the claims 1 †o 10, wherein each single hermetically packaged therapeutic dose comprises between 0.1 and 90 mg, preferably between 1 mg and 40 mg such as between 0.5 and 35 mg, preferably

between 1 and 30 mg, in particular between 2 and 25 mg of said an†i-neoplasfic agent.

12. Ki† for an inhaled chemotherapy according†o any of the claims 1 †o 1 1 , wherein each single hermetically packaged therapeutic dose comprises from 0, 1 to 99.9 mg, preferably between 1 and 49 mg of said lipid matrix.

13. Kif for an inhaled chemotherapy according†o any of the claims 1 †o 12, wherein each single hermetically packaged therapeutic dose comprises from 0.01 to 5 mg, preferably between 0.03 mg and 1 mg of PEGylafed excipient.

14. Kif for an inhaled chemotherapy according†o any of the claims 1 to 13, to be used in a polyfherapy.

1 5. Kif for an inhaled chemotherapy according†o claim

14, wherein said polyfherapy comprises one therapy chosen in the group consisting of intravenous infusion or oral chemotherapy, immunotherapy, targeted therapy, hormonotherapy, tumor ablative surgery, ablative surgery for removing a par† of or a full organ bearing a tumor, a curative surgery, a radiotherapy and their combination and a† leas† one chemotherapy by inhalation as additional therapy.

1 6. Ki† for an inhaled chemotherapy according†o claim

1 5, wherein said therapy comprises a† leas† intravenous infusion or oral chemotherapy or an immunotherapy provided†o be administered for a series of cycles, each cycle comprising an administration period and an off-period, said a† leas† one chemotherapy by inhalation being provided †o be administered in a period before said therapy and/or during said off-period.

1 7. Ki† for an inhaled chemotherapy according†o claim

1 6, wherein said administration period extends over less than one day, preferably over a period of time between 15 minutes †o 6 hours, preferably between 30 minutes and 4 hours, such as between 1 and 3 hours, and where said off-period extends over a period of time from 2†o 5 weeks, preferably from 2†o 4 weeks, more preferably between 2,5 and 3,5 weeks and particularly over about 3 weeks + 2 days.

18. Ki† for a inhaled chemotherapy according†o any of the claims 14 †o 1 7, wherein said af leas† one chemotherapy by inhalation is provided to be administered at a rate of at least 1 single hermetically packaged therapeutic dose of anti-neoplastic agent /week of period before said therapy and/or during said off-period, preferably of at least 3 single hermetically packaged therapeutic doses of anti-neoplastic agent /week of period before said therapy and/or during said off-period, more preferably of at least 5 single hermetically packaged therapeutic doses of anti-neoplastic agent /week of period before said therapy and/or during said off-period, possibly 7 single packaged therapeutic doses of anti-neoplastic agent /week of period before said therapy and/or during said off-period for a daily dosage regimen, optionally in an equally spread manner over said period before said therapy and/or during said off-period,

1 9. Kit for an inhaled chemotherapy according to claim 14 or claim 18, wherein said polytherapy comprises at least tumor ablative surgery, ablative surgery for removing a part of or a full organ bearing a tumor, a curative surgery, or a radiotherapy followed by a recovery period, said at least one chemotherapy by inhalation being provided to be administered on a period before, during or after said therapy.

20. Kit for a inhaled chemotherapy according to claim 1 9, wherein said at least one chemotherapy by inhalation is provided to be administered at a rate of at least 1 single hermetically packaged therapeutic dose of anti-neoplastic agent /week of period before, during or after said therapy, preferably of at least 3 single hermetically packaged therapeutic doses of anti-neoplastic agent/week of period before, during or after said therapy, more preferably of at least 5 single hermetically packaged therapeutic doses of anti-neoplastic agent/week of period before, during or after said therapy, possibly 7 single packaged therapeutic doses of anti-neoplastic agent/week of period before, during or after said therapy for a daily dosage regimen, optionally in an equally spread manner over said period before, during or after said therapy.

21 . Use of a kit for an inhaled chemotherapy according †o any of the claims 1 †o 13, in a polyfherapy.

22. Use of a kif for an inhaled chemotherapy according †o claim 21 , wherein said polyfherapy comprises one therapy chosen in the group consisting of intravenous infusion or oral chemotherapy, immunotherapy, targeted therapy, hormonotherapy, tumor ablative surgery, ablative surgery for removing a part of or a full organ bearing a tumor, a curative surgery, a radiotherapy and their combination and at least one chemotherapy by inhalation as additional therapy.

23. Use of a kit for an inhaled chemotherapy according to claim 22, wherein said therapy comprises at least intravenous infusion or oral chemotherapy or an immunotherapy provided to be administered for a series of cycles, each cycle comprising an administration period and an off-period, said chemotherapy by inhalation being provided to be administered during period before said therapy and/or during said off-period.

24. Use of a kit for an inhaled chemotherapy according to claim 23, wherein said administration period extends over less than one day, preferably over a period of time between 1 5 minutes to 6 hours, preferably between 30 minutes and 4 hours, such as between 1 and 3 hours, and where said off-period extends over a period of time from 2 to 5 weeks, preferably from 2 to 4 weeks, more preferably between 2,5 and 3,5 weeks and particularly over about 3 weeks + 2 days.

25. Use of a kit for a inhaled chemotherapy according to any of the claims 23 or 24, at a rate of at least 1 single hermetically packaged therapeutic dose of anti-neoplastic agent/week of period before said therapy and/or during said off-period, preferably of at least 3 single hermetically packaged therapeutic doses of anti-neoplastic agent /week of period before said therapy and/or during said off-period, more preferably of at least 5 single hermetically packaged therapeutic doses of anti-neoplastic agent /week of period before said therapy and/or during said off-period, possibly 7 single packaged therapeutic doses of anti-neoplastic agent /week of period before said therapy and/or during said off-period for a daily dosage regimen of anti-

neoplastic agent, optionally in an equally spread manner over said period before said therapy and/or during said off-period .

26. Use of a kif for an inhaled chemotherapy according to claim 21 or 25, wherein said polyfherapy comprises af leas† tumor ablative surgery, ablative surgery for removing a par† of or a full organ bearing a tumor, a curative surgery, or a radiotherapy followed by a recovery period, said a† leas† one chemotherapy by inhalation being provided †o be administered in a period before, during or after said therapy.

27. Use of a ki† for a inhaled chemotherapy according †o claim 26, wherein said chemotherapy by inhalation is provided†o be administered a† a rate of a† leas† 1 single hermetically packaged therapeutic dose of an†i-neoplas†ic agent /week, preferably of a† leas† 3 single hermetically packaged therapeutic doses of an†i-neoplas†ic agent /week, more preferably of a† leas† 5 single hermetically packaged therapeutic doses of an†i-neoplas†ic agent /week, more preferably of a† leas† 7 single hermetically packaged therapeutic doses of anti neoplastic agen†/week, optionally in an equally spread manner over said week of period before, during or after said therapy .

28. Therapeutic treatment against lung cancer comprising the steps of administering a† leas† one inhaled chemotherapy in a polytherapy comprising a† leas† one therapy chosen in the group consisting of intravenous infusion or oral chemotherapy, immunotherapy, targeted therapy, hormonotherapy, tumor ablative surgery, ablative surgery for removing a par† of or a full organ bearing a tumor, a curative surgery, a radiotherapy and their combination said a† leas† one inhaled chemotherapy being an additional therapy.

29. Therapeutic treatment against lung cancer according †o claim 28, wherein said therapy comprises a† leas† intravenous infusion or oral chemotherapy or an immunotherapy provided†o be administered for a series of cycles, each cycle comprising an administration period and an off-period, said chemotherapy by inhalation being provided †o be administered during a period before said therapy and/or during said off-period.

30. Therapeutic treatment against lung cancer according to claim 29, wherein said administration period extends over less than one day, preferably over a period of time between 15 minutes †o 6 hours, preferably between 30 minutes and 4 hours, such as between 1 and 3 hourshours, and where said off- period extends over a period of time from 2†o 5 weeks, preferably from 2†o 4 weeks, more preferably between 2,5 and 3,5 weeks and particularly over about 3 weeks + 2 days.

31 . Therapeutic treatment against lung cancer according †o any of the claims 29 or 30, wherein said a† leas† one chemotherapy by inhalation is provided†o be administered a† a rate of a† leas† 1 single hermetically packaged therapeutic dose of anti neoplastic agen†/week of period before said therapy and/or during said off-period, preferably of a† leas† 3 single hermetically packaged therapeutic doses of an†i-neoplas†ic agen†/week of period before said therapy and/or during said off-period, more preferably of a† leas† 5 single hermetically packaged therapeutic doses of an†i-neoplas†ic agen†/week of period before said therapy and/or during said off-period, possibly 7 single packaged therapeutic doses of an†i-neoplas†ic agen†/week of period before said therapy and/or during said off-period for a daily dosage regimen of an†i-neoplas†ic agent, optionally in an equally spread manner over said period before said therapy and/or during said off-period.

32. Therapeutic treatment against lung cancer according †o claim 28, wherein said polytherapy comprises a† leas† tumor ablative surgery, ablative surgery for removing a par† of or a full organ bearing a tumor, a curative surgery, or a radiotherapy followed by a recovery period, said a† leas† one chemotherapy by inhalation being provided†o be administered in a period before, during or after said therapy.

33. Therapeutic treatment against lung cancer according†o claim 32, wherein said a† leas† one inhaled chemotherapy is administered a† a rate of a† leas† 1 single hermetically packaged therapeutic dose of an†i-neoplas†ic agen†/week of period before, during or after said therapy, preferably of a† leas† 3 single hermetically

packaged therapeutic doses of an†i-neoplas†ic agen†/week of period before, during or after said therapy, more preferably of at least 5 single hermetically packaged therapeutic doses of anfi-neoplasfic agenf/week of period before, during or after said therapy, possibly 7 single packaged therapeutic doses of anfi-neoplasfic agent/week of period before, during or after said therapy for a daily dosage regimen of anti-neoplastic agent, optionally in an equally spread manner over said period before, during or after said therapy.

34. Therapeutic treatment against lung cancer according†o any of the claims 28 to 33, wherein said lung cancer is any lung tumor, such as pulmonary mefasfases, for example osteosarcoma mefasfases.

35. Therapeutic treatment against lung cancer according†o any of the claims 28 to 34, wherein said lung cancer is a small cell lung cancer.

36. Therapeutic treatment against lung cancer according†o any claims 28 to 35, wherein said lung cancer is a non-small cell lung cancer.