Claims for Patent: 10,272,102

Summary for Patent: 10,272,102

Title:	Hydroxyalkyl starch for the treatment of hematological neoplasms
Abstract:	The present invention relates to hydroxyalkyl starch or a pharmaceutical preparation thereof for the treatment of a hematological neoplasm, especially by effectively reducing proliferation rate of cancer cells and inhibiting cancer cell growth and wherein the hydroxyalkyl starch has a mean molecular weight (MW) above 20 and below 1300 kDa and a molar substitution (MS) in the range of from 0.1 to 1.5, wherein the alkylation may be an ethylation, propylation or butylation or mixes thereof; and wherein the alkyl may be further substituted.
Inventor(s):	Westphal; Martin (Bad Homburg, DE), Baasner; Silke (Schoneck, DE)
Assignee:	FRESENIUS KABI DEUTSCHLAND GMBH (Bad Homburg, DE)
Application Number:	14/909,284
Patent Claims:	1. A method of treating a subject who has a hematological neoplasm, the method comprising administering a therapeutically effective amount of hydroxyethyl starch (HES) to the subject; wherein the HES has a mean molecular weight (MW) above 20 and below 1300 kDa and a molar substitution (MS) in the range of from 0.1 to 1.5. 2. The method of claim 1, wherein the hematological neoplasm is leukemia or lymphoma. 3. The method of claim 1, wherein the treatment comprises at least one of reducing the growth or proliferation of hematological neoplastic cells or inhibiting hematological neoplastic cell infiltration into peripheral organs. 4. The method of claim 1, wherein the HES is administered as a first compound, either before or after administration of a second therapeutically effective compound. 5. The method of claim 4, wherein the second compound is a cytostatica, a biological with anti-cancer activity, or a hormone with anti-cancer activity. 6. The method of claim 4, wherein the second compound is selected from the group consisting of a cytostatica and a biological with anti-cancer activity. 7. The method of claim 4, wherein the second compound is a cytostatica. 8. The method of claim 5, wherein the cytostatica is an alkylating agent, an alkyl sulfonate, and antimetabolite, an anti-tumor antibiotic, a topoisomerase inhibitor, a differentiating agent selected from the group consisting of tretinoin, bexarotene, and arsenic trioxide, a mitotic inhibitor, a tyrosine kinase inhibitor selected from the group consisting of imatinib, dasatinib, ponatinib, ibrutinib, bosutinib, and nilotinib, a proteasome inhibitor or plerixafor. 9. The method of claim 4, wherein the second compound is a biological with anti-cancer activity. 10. The method of claim 5, wherein the biological with anti-cancer activity consists of an antibody tyrosine kinase inhibitor, a monoclonal antibody or an immunomodulating drug selected from the group consisting of thalidomide, lenalidomide, and pomalidomide. 11. The method of claim 1, wherein the hematological neoplasm is selected from the group consisting of myeloproliferative neoplasms, myeloid and lymphoid neoplasms associated with eosinophilia and abnormalities of platelet-derived growth factor receptor alpha (PDGFRA), platelet-derived growth factor receptor beta (PDGFRB), or fibroblast growth factor receptor-1 (FGFR1), myelodisplastic/myeloproliferative neoplasms (MDS/MPN), myelodisplastic syndromes, acute myeloid leukemia (AML), acute leukemia of ambiguous lineage, precursor lymphoid neoplasms, mature B-cell neoplasms, mature T-cell and NK-cell neoplasms, Hodgkin lymphoma, histiocytic and dendritic cell neoplasms, and post transplantation lymphoproliferative disorders (PTLDs). 12. The method of claim 1, wherein the treatment comprises arresting the mitotic cycle of a hematological neoplasm cell. 13. The method of claim 8, wherein alkylating agent is cyclophosphamide. 14. The method of claim 1, wherein the HES is HES 130/0.4; HES 100/1.0/1.3; HES 200/0.5; HES 70/0.4/1.8; HES 70/0.5; HES 100/0.1/2.0 (with a mean molecular weight of 100 kDa, a molar substitution degree of 0.1 and a poly dispersity index (PDI) of 2.0); HES 100/0.1/2.0 (with a mean molecular weight of 130 kDa, a molar substitution degree of 0.1 and a PDI of 2.0); HES 100/0.7/1.3; HES 100/1.0/1.1; HES 150/0.7/1.3 (with a mean molecular weight of 150 kDa, a molar substitution degree of 0.7 and a PDI of 1.3); HES 150/1.0/1.3 (with a mean molecular weight of 150 kDa, a molar substitution degree of 1.0 and a PDI of 1.3); HES 180/0.4; HES 200/0.5; HES 250/0.45; HES 300/1.0/1.3; HES with a mean molecular weight of 300 kDa, HES 450/0.7; HES with a mean molecular weight of 500 kDa, a molar substitution degree of 0.28 and a C2/C6 ratio of 8.7; HES with a mean molecular weight of 500 kDa and a molar substitution degree MS between 0.25 and 0.5 and a C2/C6 ratio of 2 to below 8; HES with a mean molecular weight of 600 kDa and a molar substitution degree of 0.5; HES 700/0.5/2.5; HES 700/0.7; HES 700/0.7/2.0; HES 700/1.0/1.5; HES 700/1.3/1.5; HES 60/1.3/1.3; a HES with a mean molecular weight Mw of 1000 kDa and a substitution degree Ds between 4 and 10; and HES 70/0.55. 15. The method of claim 14, wherein the HES 130/0.4 has a molar substitution degree of 0.38-0.45, a mean molar substitution degree of 0.42, a C2/C6 ratio between 8.0 and 12.0, and a PDI between 1.7 and 2.3. 16. The method of claim 10, where the antibody tyrosine kinase inhibitor is cetuximab, bevacizumab, panitumumab, or trastuzumab.

Details for Patent 10,272,102

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2033-07-30
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2033-07-30
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2033-07-30
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2033-07-30
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2033-07-30
Amgen, Inc.	VECTIBIX	panitumumab	Injection	125147	09/27/2006		2033-07-30