You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 10,119,976


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,119,976
Title:Method of assessing risk of PML
Abstract: The invention relates to methods of assessing a patient\'s risk of developing Progressive multifocal leukoencephalopathy (PML).
Inventor(s): Bloomgren; Gary Lewis (Concord, MA), Bozic; Carmen (Newton, MA), Lee; Sophia (Waltham, MA), Pace; Amy (Brookline, MA), Plavina; Tatiana (North Reading, MA), Subramanyam; Meena (Stoneham, MA)
Assignee: Biogen MA Inc. (Cambridge, MA)
Application Number:14/893,989
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,119,976
Patent Claims:1. A method of evaluating a patient's risk of developing Progressive Multifocal Leukoencephalopathy (PML), the method comprising: determining a JC virus (JCV) antibody titer in a biological sample from the patient, wherein the patient has a negative prior immunosuppressant exposure classification; wherein if the titer is determined to be above a pre-determined level, the patient is determined to be at a higher risk of developing PML, and wherein if the titer is determined to be at or below an index level of 0.9, the patient is determined to be at a lower risk of developing PML.

2. The method of claim 1, wherein the pre-determined level is 0.9.

3. The method of claim 1, wherein the pre-determined level is 1.2.

4. The method of claim 1, wherein the pre-determined level is 1.5.

5. The method of claim 1, wherein the negative prior immunosuppressant exposure classification comprises that the patient has been free of a non-anti-VLA-4 immunosuppressant therapy for a period within 1, 3, or 5 years.

6. The method of claim 1, wherein the negative prior immunosuppressant exposure classification comprises that the patient has been free of a non-anti-VLA-4 immunosuppressant therapy for the patient's lifetime.

7. The method of claim 1, wherein if the patient is determined to be at lower risk of developing PML, then the patient is classified as being suitable for treatment with an anti-VLA-4 therapy.

8. The method of claim 7, further comprising administering an anti-VLA-4 therapy to the patient.

9. The method of claim 7, wherein the anti-VLA-4 therapy is a natalizumab therapy.

10. The method of claim 1, wherein the patient has previously received an anti-VLA-4 therapy.

11. The method of claim 1, further comprising determining a second or further JCV antibody titer in a second or further biological sample from the patient, wherein the second or further biological sample is obtained from the patient at a period of time after the first biological sample, and wherein: if the titer is determined to be above zero, but at or below a pre-determined level in the two or more samples, the patient is determined to be at a lower risk of developing PML, and if the titer is determined to be above a pre-determined level in the two or more samples, the patient is determined to be at a higher risk of developing PML.

12. The method of claim 11, wherein the pre-determined level is an index level of 0.9.

13. The method of claim 11, wherein the pre-determined level is an index level of 1.2.

14. The method of claim 11, wherein the pre-determined level is an index level of 1.5.

15. The method of claim 11, wherein the period of time is 6 months.

16. The method of claim 11, wherein the period of time is 12 months.

17. The method of claim 11, wherein the period of time is 18 months.

18. The method of claim 11, wherein the two or more samples are consecutive samples.

19. The method of claim 11, wherein the titer in every sample obtained from the patient over a period of time is determined to be at or below a pre-determined level.

20. The method of claim 11, wherein the titer in every sample obtained from the patient over a period of time is determined to be above a pre-determined level.

21. The method of claim 11, wherein the patient as has received an anti-VLA-4 therapy during the period of time.

22. A method of evaluating a patient's risk of developing Progressive Multifocal Leukoencephalopathy (PML), the method comprising: determining a JC virus (JCV) antibody titer in a biological sample from the patient, wherein the patient has a negative prior immunosuppressant exposure classification; wherein if the titer is determined to be at or below an index level of 0.9, the patient is determined to be at a lower risk of developing PML.

23. The method of claim 22, further comprising administering an anti-VLA4 antibody if the patient is determined to be a lower risk of developing PML.

24. The method of claim 23, wherein the anti-VLA4 antibody is natalizumab.

25. A method of treating an MS patient, comprising: administering an anti-VLA4 antibody responsive to a determination of a JC virus (JCV) antibody titer at or below an index level of 0.9 in a patient having a negative prior immunosuppressant exposure classification, thereby treating the patient.

26. The method of claim 25, wherein the anti-VLA4 antibody is natalizumab.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.