Well CLTR +4 and IDPH -20 as I write. May also be related to news that the Zevalin NDA will be delayed to the fourth quarter 2000.
Here's the claim for the new patent. Note that Y-90 is explicitly mentioned.
1. A composition comprising:
(1) a radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment in an amount providing 1 to 200 mCi of radioactivity and providing irradiation in a dose range of 10 to 200 cGy to the whole body of a human patient, said amount being effective for achieving remission of B-cell lymphoma in the patient, wherein said antibody or said antibody fragment binds to CD20 antigen present on the surface of cells of B-cell lymphoma and wherein the amount of radioactivity that labels the antibody or antibody fragment is less than the amount which causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells into said patient in order for the patient to recover hematopoietic function, and
(2) a pharmaceutically acceptable carrier.
2. The composition of claim 1, wherein the radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment is labelled with a .beta.-emitter.
3. The composition of claim 2, wherein the radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment is labelled with an isotope selected from the group consisting of .sup.131, .sup.90 Y, .sup.188 Re, and .sup.186 Re.
4. The composition of claim 1, wherein the amount of the radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment provides irradiation in a dose range of 15 to 150 cGy to the whole body of the patient.
5. The composition of claim 4, wherein the amount of the radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment provides irradiation in a dose range of 25 to 100 cGy to the whole body of the patient.
6. The composition of claim 5, wherein the amount of the radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment provides an irradiation dose of 75 cGy to the whole body of the patient.
7. The composition of claim 1, wherein the amount of the radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment is an amount providing 1 to 150 mCi of radioactivity.
8. The composition of claim 7, wherein the amount of the radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment is an amount providing 1 to 100 mCi of radioactivity.
9. The composition of claim 3, wherein the isotope is .sup.131 I.
10. The composition of claim 3, wherein the isotope is .sup.90 Y.
11. The composition of claim 1, wherein the radioactively labeled monoclonal antibody or radioactively labeled monoclonal antibody fragment has a specific activity in a range of 1 to 10 mCi/mg.
12. The composition of claim 1 wherein the amount of the radioactively labeled monoclonal antibody or radioactively labeled monoclonal antibody fragment has sufficient affinity and specific activity to deliver 10.6+/-2.76 cGy/mCi to a tumor targeted by the antibody or antibody fragment when administered to a patient.
Peter |
