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Last Updated: August 13, 2020

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Claims for Patent: 9,511,046

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Summary for Patent: 9,511,046
Title:Methods of treating pancreatic cancer
Abstract: Provided herein are methods for the treatment of metastatic pancreatic cancer comprising administration of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein in combination with gemcitabine.
Inventor(s): Desai; Neil P. (Los Angeles, CA), Renschler; Markus (San Francisco, CA)
Assignee: ABRAXIS BIOSCIENCE, LLC (Los Angeles, CA)
Application Number:13/794,480
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,511,046
Patent Claims: 1. A method of treating metastatic or locally advanced pancreatic cancer in a human individual comprising administering to the individual (a) an effective amount of a composition comprising nanoparticles comprising paclitaxel and an albumin; and (b) an effective amount of gemcitabine, wherein the individual is selected for treatment based on (i) having metastasis in the liver, (ii) having more than 3 metastatic sites, (iii) having pancreatic cancer in the primary location in the head of the pancreas, or (iv) having serum CA19-9 level that is .gtoreq.59.times.ULN (Upper Limit of Normal).

2. The method of claim 1, wherein the pancreatic cancer is pancreatic adenocarcinoma.

3. The method of claim 1, wherein the individual has Karnofsky performance status (KPS) of between 70 and 80.

4. The method of claim 1, wherein the individual has a high level of hENT1 (human equilibrative nucleoside transporter 1).

5. The method claim 1, wherein the composition comprising nanoparticles comprising paclitaxel and albumin is administered intravenously.

6. The method of claim 1, wherein the dose of paclitaxel in the nanoparticle composition is about 50 mg/m.sup.2 to about 200 mg/m.sup.2.

7. The method of claim 6, wherein the dose of paclitaxel in the nanoparticle composition is about 125 mg/m.sup.2.

8. The method of claim 6, wherein the composition comprising nanoparticles comprising paclitaxel and albumin is administered weekly, three out of four weeks.

9. The method of claim 1, wherein the albumin is human serum albumin.

10. The method of claim 1, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm.

11. The method of claim 1, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

12. The method of claim 1, wherein the paclitaxel in the nanoparticles is coated with the albumin.

13. The method of claim 1, wherein gemcitabine is administered to the individual at about 500 mg/m.sup.2 to about 2000 mg/m.sup.2.

14. The method of claim 13, wherein gemcitabine is administered to the individual at about 1000 mg/m.sup.2.

15. The method of claim 13, wherein gemcitabine is administered weekly, three out of four weeks.

16. The method of claim 13, wherein gemcitabine is administered intravenously.

17. The method of claim 1, wherein the method is for first-line treatment.

18. The method of claim 1, further comprising selecting the individual for treatment based on the individual (i) having metastasis in the liver, (ii) having more than 3 metastatic sites, (iii) having pancreatic cancer in the primary location in the head of the pancreas, or (iv) having serum CA19-9 level that is .gtoreq.59.times.ULN (Upper Limit of Normal).

19. The method of claim 1, further comprising determining (i) the metastasis status, (ii) primary location of the pancreatic cancer, or (iii) CA19-9 level in the individual.

20. The method of claim 10, wherein the paclitaxel in the nanoparticles is coated with the albumin, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

21. The method of claim 1, wherein the individual is selected for treatment based on having metastasis in the liver.

22. The method of claim 21, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm, wherein the paclitaxel in the nanoparticles is coated with the albumin, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

23. The method of claim 1, wherein the individual is selected for treatment based on having more than 3 metastatic sites.

24. The method of claim 23, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm, wherein the paclitaxel in the nanoparticles is coated with the albumin, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

25. The method of claim 1, wherein the individual is selected for treatment based on having pancreatic cancer in the primary location in the head of the pancreas.

26. The method of claim 25, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm, wherein the paclitaxel in the nanoparticles is coated with the albumin, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

27. The method of claim 1, wherein the individual is selected for treatment based on having serum CA19-9 level that is .gtoreq.59.times.ULN (Upper Limit of Normal).

28. The method of claim 27, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm, wherein the paclitaxel in the nanoparticles is coated with the albumin, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

29. The method of claim 11, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

30. The method of claim 20, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

31. The method of claim 22, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

32. The method of claim 24, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

33. The method of claim 26, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

34. The method of claim 28, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

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