IP Library Granted Patent US 10,633,413
Granted Patent B2
US 10,633,413 · App. 16/035,537 · Granted Apr 28, 2020

Methods of treating Parkinson's disease using aminosterols and compositions comprising the same

Inventor: Michael Zasloff (Merion, PA)
Assignee: ENTERIN, INC.
C07J41/0005A61K31/575A61K45/06A61P1/10A61P25/24A61P25/28
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Quick Facts
Patent No.
US 10,633,413
App. No.
16/035,537
Granted
Apr 28, 2020
Kind
B2
Abstract

This invention relates to methods of stimulating the activity of the human and animal enteric nervous system. The method comprises orally administering an aminosterol, such as squalamine, a naturally occurring aminosterol isolated from Squalus acanthias , or derivatives thereof, to a subject in need.

Claims (36)

1. A method of treating Parkinson's disease in a subject comprising orally administering to the subject in need thereof a therapeutically effective amount of a composition comprising a pharmaceutically acceptable grade of an aminosterol, or a pharmaceutically acceptable salt or derivative thereof, wherein the aminosterol is Aminosterol 1436.

2. The method of claim 1 , wherein the therapeutically effective amount is the amount sufficient to produce a beneficial neuro-protective effect.

3. The method of claim 2 , wherein the amount sufficient to produce a beneficial neuro-protective effect is about 0.1 to about 20 mg/kg body weight.

4. The method of claim 1 , wherein the aminosterol is administered in combination with at least one additional active agent commonly prescribed to treat Parkinson's disease or related symptoms to achieve either an additive or synergistic effect.

5. The method of claim 4 , wherein the additional active agent is administered via a method selected from the group consisting of

(a) concomitantly;

(b) as an admixture;

(c) separately and simultaneously or concurrently; and

(d) separately and sequentially.

6. The method of claim 1 , wherein the composition is formulated into an oral dosage form which is a liquid, capsule, or tablet designed to disintegrate in either the stomach, upper small intestine, or more distal portions of the intestine with a dissolution rate appropriate to achieve the intended therapeutic benefit.

7. The method of claim 1 , wherein following oral administration there is less than about 10 ng/ml of the administered aminosterol in the bloodstream of the subject, measured between about 1 to about 12 hours following oral administration.

8. The method of claim 1 , wherein the composition further comprises at least one pharmaceutically acceptable carrier.

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

10. The method of claim 4 , wherein the one or more drugs commonly prescribed to treat Parkinson's disease or related symptoms are selected from the group consisting of levodopa, a dopa decarboxylase inhibitor, a COMT inhibitor, dopamine agonists, MAO-B inhibitors, carbidopa, benserazide, tolcapone, entacapone, bromocriptine, pergolide, pramipexole, ropinirole, piribedil, cabergoline, apomorphine, lisuride, rotigotine, rasagiline, amantadine, anticholinergics, clozapine, cholinesterase inhibitors, and modafinil.

11. The method of claim 1 , comprising administering to the subject in need a combination of:

(a) a pharmaceutically acceptable grade of squalamine; and

(b) a pharmaceutically acceptable grade of Aminosterol 1436,

wherein the squalamine and Aminosterol 1436 are present in the same or separate compositions.

12. The method of claim 1 , wherein the method produces one or more of the following in the subject:

(a) improved bowel function;

(b) improved fine motor skills;

(c) improved articulation;

(d) improved mood;

(e) improved speech;

(f) improved mood;

(g) improved tremors;

(h) improved coordination;

(i) improved stamina;

(j) improved balance;

(k) improved cognitive function; and/or

(l) reduced dysphagia/improved swallowing;

(m) improved autonomic function;

(n) improved psychosis (hallucinations and delusions; and/or

(o) improved daytime wakefulness.

13. The method of claim 1 , wherein the method results in triggering the production of neuro-protective hormones or neuropeptides which function to prevent or slow onset, development, or advancement of Parkinson's Disease or related symptoms.

14. The method of claim 1 , wherein the method results in preventing the accumulation of alpha synuclein, thereby preventing or slowing onset, development, or advancement of Parkinson's Disease or related symptoms.

Assignments (1)
CHANGE OF NAME Recorded Feb 28, 2020
From: ENTERIN LABORATORIES, INC.
To: ENTERIN, INC.
Reel/Frame 052134/0198 →
Continuity (4)
Continuation 14329627 · Jul 11, 2014
Provisional Application 61886512 · Oct 3, 2013
Provisional Application 62015657 · Jun 23, 2014
Related Publication 20180319837A1 · Nov 8, 2018