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Cannabinoids for prophylactic treatment of involuntary weight loss

a technology of involuntary weight loss and cannabis, applied in the direction of drug composition, muscular disorder, metabolic disorder, etc., can solve the problems of inability to receive anti-cancer therapies, inability to treat the effects of cancer, and inability to induce cachexia, etc., to achieve the effect of treating or preventing undesirable muscle or fat loss

Inactive Publication Date: 2021-07-15
AOP ORPHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

Significantly reduces weight loss and maintains a low Glasgow prognostic score, thereby delaying the onset and severity of cachexia, improving quality of life and survival in cancer patients.

Problems solved by technology

Despite interventions such as total parenteral nutrition (complete daily intravenous nutrition), anti-inflammatory medications, and anabolic stimulation, patients with cancer-induced cachexia continue to lose weight and often become so frail that they are unable to receive anti-cancer therapies.
However, the efficacy of these new treatment regimens does not guarantee an increase in survival.
While surgery, radiation or chemotherapy can reduce tumor size, this reduction does not always correlate with an increase in survival.
These losses have proven refractory to all therapeutic interventions, except for a complete removal of the cancer, which remains elusive for the vast majority of cancer patients.
Despite being common in many solid tumor cancers, cachexia remains a largely untreated complication that predisposes patients to an increased mortality.
Treatment approaches for CIC, including anabolic steroids, anti-catabolic therapies, appetite stimulants, and nutritional interventions, have failed to show significant efficacy.
In fact, once established, no therapeutic approach has been able to reverse cancer-induced cachexia.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0161]Prospective, single center, randomized, double-blind placebo-controlled study evaluating the effectiveness of low dose cannabinoid therapy with nabilone (Canemes®) in prophylactic treatment of cachexia in patients with verified, metastatic colorectal or metastatic pancreatic cancer. The aim of the study is the prevention of critical weight loss of more than 10% in patients with metastatic colorectal or metastatic pancreatic cancer by supplementary administration of low dose cannabinoid nabilone (Canemes®).

[0162]Patients are Treated by One of Following Chemotherapies:

[0163]a) Palliative Chemotherapy (Platin-Based):

[0164]Pancreatic Cancer:

[0165]Cisplatin (Cisplatin) 25 mg / m2 i.v.

[0166]Gemcitabine (Gemzar) 1000 mg / m2 i.v.

[0167](day 1 and day 8, repeat on day 22—in total 8 cycles until progression)

[0168]Colorectal Cancer:

[0169]Capecitabine (Xeloda) 2500 mg / m2 p.o.

[0170](day 1-14, repeat on day 22—until disease progression) according to local standard

[0171]Arm A (control group): Pl...

example 2

[0223]Case study evaluating the effectiveness of low dose cannabinoid therapy with nabilone (Canemes®) in prophylactic treatment of cachexia in patients with verified, metastatic colorectal cancer. The aim of the study is the prevention of critical weight loss of more than 10% in patients with metastatic colorectal cancer by supplementary administration of low dose cannabinoid nabilone (Canemes®).

[0224]Patients will be treated with chemotherapy chosen by a specialist. Additionally, after diagnosis and before chemotherapy, supplemental daily administration of synthetic cannabinoid nabilone 0.25 mg capsules is started and if necessary the dose is escalated to 0.5 mg.

[0225]Weight and inflammatory parameters (CRP and albumin) will be measured at baseline, and subsequently during chemotherapy over the period of the chemotherapy and up to six months thereafter.

[0226]Weight loss by more than 5%, in combination with increased levels of CRP and decreased levels of albumin will be evaluated i...

example 3

[0227]Case study evaluating the effectiveness of low dose cannabinoid therapy with nabilone (Canemes®) in prophylactic treatment of cachexia in patients with verified, metastatic colorectal cancer. The aim of the study is the prevention of critical weight loss of more than 10% in patients with metastatic colorectal cancer by supplementary administration of low dose cannabinoid nabilone (Canemes®).

[0228]Patients will be treated with chemotherapy chosen by a specialist. Additionally, after diagnosis and before chemotherapy, supplemental daily administration of synthetic cannabinoid nabilone 0.25 mg capsules is started and if necessary the dose is escalated to 0.5 mg.

[0229]Weight will be measured at baseline, and subsequently during chemotherapy over the period of the chemotherapy and up to six months thereafter.

[0230]Weight loss by more than 5% will be evaluated in order to detect signs of pre-cachexia.

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PUM

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Abstract

The present invention provides a new use for cannabinoids in the prevention of pre-cachexia or cachexia in a patient suffering from cancer, wherein said cannabinoid is administered-at low dosage and wherein administration is started prior to chemotherapy and is maintained for at least the duration of the chemotherapy.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 16 / 464,247 filed on May 24, 2019, which is the U.S. national stage of International Patent Application No. PCT / EP2017 / 080353 filed on Nov. 24, 2017, which claims the benefit of priority under 35 U.S.C. § 119 from European Patent Application No. 16200498.0 filed Nov. 24, 2016. The disclosures of the foregoing applications are incorporated herein by reference in their entirety.FIELD OF THE INVENTION[0002]The present invention provides a new use for cannabinoids at low dosage in the prevention of pre-cachexia or cachexia in a patient suffering from cancer, wherein administration is started prior to chemotherapy and is maintained for at least the duration of the chemotherapy.BACKGROUND OF THE INVENTION[0003]Cachexia is a wasting syndrome associated with chronic diseases such as cancer, chronic obstructive pulmonary disease (COPD), sepsis, or chronic heart failure. Accordin...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/352A61P3/04A61P35/00A61K9/00A61K45/06A61K33/24A61K33/243
CPCA61K31/352A61P3/04A61K45/06A61K9/0002A61K9/0053A61P35/00A61K31/05A61K31/164A61K31/473A61K31/5375A61K31/7068A61K33/24A61P21/00A61P43/00A61K33/243A61K2300/00
Inventor KOHL, AGNESLENHARD, RALF
Owner AOP ORPHAN PHARMA
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