Use of methylnaltrexone to attenuate tumor progression

A methylnaltrexone, tumor technology, applied in the field of using methylnaltrexone to slow tumor progression, can solve problems such as constipation, reduction of intestinal transit rate, severe itching, etc.

Inactive Publication Date: 2017-10-13
SALIX PHARMA INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, opioids also react with receptors outside the central nervous system, causing side effects including constipation, nausea, vomiting, urinary retention, and severe itching
Of note is t

Method used

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  • Use of methylnaltrexone to attenuate tumor progression
  • Use of methylnaltrexone to attenuate tumor progression
  • Use of methylnaltrexone to attenuate tumor progression

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0383] Example 1: Study 1

[0384] A double-blind randomized placebo-controlled study of subcutaneous methylnaltrexone (MNTX) was conducted in subjects with advanced medical disease and a prior history of opioid-induced constipation. To meet the eligibility criteria for recruitment, subjects were required to start a stable dose of laxative and opioid analgesics. In the context of the study, a stable dose of opioid analgesic was defined as no decrease in the dose of opioid analgesic by ≥ 50% for at least 3 days prior to the first dose of MNTX. Stable laxative dosing was defined as a long-term laxative order (not PRN or as needed) for at least 3 days prior to the first dose of MNTX. If the subject has had less than 3 bowel movements in the previous few weeks according to the medical history and has no clinically significant bowel movement within 24 hours before the first dose of MNTX, or has no clinically significant bowel movement within 48 hours before the first dose of MNTX ...

Embodiment 2

[0394] Example 2: Study 2

[0395]A double-blind randomized placebo-controlled study of subcutaneous MNTX was conducted in subjects with advanced medical disease and a prior history of opioid-induced constipation. To meet the eligibility criteria for recruitment, subjects were required to start a stable dose of laxative and opioid analgesics. In the context of the study, a stable dose of opioid analgesic was defined as no decrease in the dose of opioid analgesic by ≥ 50% for at least 3 days prior to the first dose of MNTX. Stable laxative dosing was defined as a long-term laxative order (not PRN or as needed) for at least 3 days prior to the first dose of MNTX. If the subject (a) has had less than 3 bowel movements in the previous few weeks according to the medical history and has not had a clinically significant bowel movement within 24 hours before the first dose of MNTX, or (b) 48 hours before the first dose of MNTX In the absence of clinically significant laxation, a dia...

Embodiment 3

[0408] Methylnaltrexone (MNTX) is approved for the treatment of opioid-induced constipation (OIC) in subjects with advanced disease receiving palliative care when the response to laxative therapy is inadequate. Because MNTX is restricted across the blood-brain barrier, it can be administered to cancer subjects receiving opioid therapy without affecting analgesia. Recent cellular, molecular, animal and human data suggest that the mu opioid receptor (MOR) can be a target for chemotherapeutic agents. MNTX has been shown to potentially slow cancer progression. In animal models, mu opiate receptor (MOR) antagonists reduce tumor growth in lung, head and neck, breast and pancreatic tumors at clinically relevant doses. MOR knockout mice show reduced tumor growth and metastasis in lung cancer and melanoma. In a Lewis lung cancer model, infusion of MNTX significantly reduced growth and metastasis. In addition, polymorphisms of MOR that confer opioid resistance significantly prolong s...

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Abstract

Presented herein are methods for preventing or treating tumor growth, tumor metastasis and/or abnormal proliferation of tumor cells in a subject, wherein the methods involve administration of a pharmaceutical composition comprising methylnaltrexone. Also presented herein are methods for inhibiting or slowing the growth of a tumor in a subject, wherein the methods include selecting a subject who is a suitable candidate for treatment with methylnaltrexone, and administering a composition comprising methylnaltrexone to the subject.

Description

[0001] related application [0002] This application claims U.S. Provisional Application No. 62 / 065,550, filed October 17, 2014, U.S. Provisional Application No. 62 / 140,876, filed March 31, 2015, and U.S. Provisional Application No. 62 / 222,746, filed September 23, 2015 priority. The entire content of each of these applications is incorporated herein by reference. Background of the invention [0003] Opioids are widely used to treat subjects suffering from pain. Such subjects include subjects with advanced cancer and other terminal diseases as well as subjects with chronic non-malignant pain and acute non-malignant pain. Opioids are narcotic drugs that activate opioid receptors located in the central nervous system to relieve pain. However, opioids also react with receptors outside the central nervous system, leading to side effects including constipation, nausea, vomiting, urinary retention, and severe itching. Of note is the role of opioids in the gastrointestinal (GI) tr...

Claims

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Application Information

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IPC IPC(8): A01N43/42
CPCA61K31/485A61P1/10A61P35/00A61B5/4848A61K9/0053A61K9/20A61K45/06A61K49/0004
Inventor J.莫斯L.K.约翰逊
Owner SALIX PHARMA INC
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