IP Library Granted Patent US 10,272,101
Granted Patent B2
US 10,272,101 · App. 15/437,778 · Granted Apr 30, 2019

Glucan preparations

Inventors: Andrew Magee (Maynard, MA); James Rolke (Woburn, MA); Ren-der Yang (Terre Haute, IN)
Assignee: BIOTHERA INC.
A61K31/716C08B37/0024C08L5/00A61K2039/545
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Quick Facts
Patent No.
US 10,272,101
App. No.
15/437,778
Granted
Apr 30, 2019
Kind
B2
Abstract

Particulate β-glucan is solubilized at elevated pressure and temperature to form soluble β-glucan. The method is safe and economical and produces a product that is an improved pharmaceutical agent.

Claims (30)

1. A method of stimulating the immune system of a patient comprising:

administering to the patient a composition comprising underivatized, soluble β-glucan derived from Saccharomyces cerevisiae and having immunostimulatory properties and an average molecular weight between about 120,000 Da and about 205,000Da;

soluble β-glucan having a molecular weight over 380,000 Da in an amount less than or equal to 10%; and β-glucan having a molecular weight under 25,000 Da in an amount less than or equal to 17%,

wherein the underivatized, soluble β-glucan is prepared by applying pressure to a suspension comprising particulate β-glucan and acetic acid, and heating the suspension for a time sufficient to form the soluble β-glucan, wherein the suspension is buffered to a pH of about 3.6, and where the underivatized, soluble β-glucan is not treated with caustic solution during preparation.

2. The method of claim 1 , wherein the patient has undergone cytoreductive therapy.

3. The method of claim 2 , wherein the cytoreductive therapy is high dose chemotherapy or radiation.

4. The method of claim 1 , wherein the method induces hematopoietic stem and progenitor cell (HSPC) mobilization in the patient.

5. The method of claim 1 , wherein the patient has cancer.

6. The method of claim 1 , wherein the composition does not induce a biochemical mediator that causes side effects.

7. The method of claim 6 , wherein the biochemical mediator is interleukin-1 β or tumor necrosis factor-α.

8. The method of claim 1 , wherein the underivatized, soluble β-glucan forms a triple helix aggregate having a molecular weight between about 25,000 Da and about 380,000 Da.

9. The method of claim 1 , wherein the underivatized, soluble β-glucan has a molecular weight over 380,000 Da in an amount of from 4% to 8%.

10. The method of claim 1 , wherein the underivatized, soluble β-glucan has a molecular weight under 25,000 Da in an amount of from 8% to 13%.

11. A method of mobilizing stem cells of a patient comprising:

administering to the patient a composition comprising underivatized, soluble β-glucan derived from Saccharomyces cerevisiae and having immunostimulatory properties and an average molecular weight between about 120,000 Da and about 205,000 Da;

soluble β-glucan having a molecular weight over 380,000 Da in an amount less than or equal to 10%; and β-glucan having a molecular weight under 25,000 Da in an amount less than or equal to 17%,

wherein the underivatized, soluble β-glucan is prepared by applying pressure to a suspension comprising particulate β-glucan and acetic acid, and heating the suspension for a time sufficient to form the soluble β-glucan, wherein the suspension is buffered to a pH of about 3.6, and where the underivatized, soluble β-glucan is not treated with caustic solution during preparation.

12. The method of claim 11 , wherein the patient has undergone cytoreductive therapy.

13. The method of claim 12 , wherein the cytoreductive therapy is high dose chemotherapy or radiation.

14. The method of claim 11 , wherein the stem cell mobilization is hematopoietic stem and progenitor cell (HSPC) mobilization in the patient.

15. The method of claim 11 , wherein the patient has cancer.

16. The method of claim 11 , wherein the composition does not induce a biochemical mediator that causes side effects.

17. The method of claim 16 , wherein the biochemical mediator is interleukin-1 β or tumor necrosis factor-α.

18. The method of claim 11 , wherein the underivatized, soluble β-glucan forms a triple helix aggregate having a molecular weight between about 25,000 Da and about 380,000 Da.

19. The method of claim 11 , wherein the underivatized, soluble β-glucan has a molecular weight over 380,000 Da in an amount of from 4% to 8%.

20. The method of claim 11 , wherein the underivatized, soluble β-glucan has a molecular weight under 25,000 Da in an amount of from 8% to 13%.

21. A method treating cancer in a patient comprising:

administering a cytoreductive therapy to the patient; and

administering a composition comprising soluble β-glucan having a molecular weight over 380,000 Da in an amount less than or equal to 10%; and β-glucan having a molecular weight under 25,000 Da in an amount less than or equal to 17%,

wherein the underivatized, soluble β-glucan is prepared by applying pressure to a suspension comprising particulate β-glucan and acetic acid, and heating the suspension for a time sufficient to form the soluble β-glucan, wherein the suspension is buffered to a pH of about 3.6, and where the underivatized, soluble β-glucan is not treated with caustic solution during preparation.

Assignments (6)
CORRECTIVE ASSIGNMENT TO CORRECT THE APPLICATION NUMBER 14/528,900, PREVIOUSLY RECORDED AT REEL: 053295 FRAME: 0844. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Feb 3, 2021
From: BIOTHERA, INC.
To: HIBERCELL, INC.
Reel/Frame 055222/0039 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 19, 2020
From: BIOTHERA, INC.
To: HIBERCELL, INC.
Reel/Frame 053544/0350 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 19, 2020
From: BIOTHERA, INC.
To: HIBERCELL, INC.
Reel/Frame 053544/0365 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2020
From: BIOTHERA, INC.
To: HIBERCELL, INC.
Reel/Frame 053295/0844 →
RELEASE OF SECURITY INTEREST Recorded Apr 2, 2020
From: MIDCAP FINANCIAL SERVICES, LLC
To: BIOTHERA, INC.; LIFE SOURCE BASICS INC.; BIOTHERA HEALTH INC.
Reel/Frame 052297/0045 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2018
From: MAGEE, ANDREW; ROLKE, JAMES; YANG, REN-DER
To: BIOTHERA INC.
Reel/Frame 044875/0775 →
Continuity (3)
Continuation 11818741 · Jun 15, 2007
Provisional Application 60813971 · Jun 15, 2006
Related Publication 20170304352A1 · Oct 26, 2017