The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.
Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks.

Start Date01 Mar 2024

Sponsor / Collaborator-

CTRI/2024/02/062402 / Not yet recruitingPhase 2

Pharmacokinetic Study of Palmitoylethanolamide (PEA) Extract in Healthy Human Volunteers. - Nil

Start Date16 Feb 2024

Sponsor / Collaborator

Tilman SA

CTRI/2023/05/052853 / Not yet recruitingNot Applicable

A randomized, single-dose, double-blind, 2-way crossover, 2 sequence study to assess the bioavailability of formulated Palmitoylethanolamide (FPEA-1-23) in comparison with normal unformulated Palmitoylethanolamide (UFPEA-1-23) supplementation in healthy volunteers.

Start Date27 May 2023

Sponsor / Collaborator-

100 Clinical Results associated with Palmitoylethanolamide

100 Translational Medicine associated with Palmitoylethanolamide

100 Patents (Medical) associated with Palmitoylethanolamide

764

Literatures (Medical) associated with Palmitoylethanolamide

01 Jun 2024·Biomedicine & Pharmacotherapy

PEA-OXA restores cognitive impairments associated with vitamin D deficiency-dependent alterations of the gut microbiota

Article

Author: Di Marzo, Vincenzo ; Perrone, Michela ; Infantino, Rosmara ; Di Martino, Emanuele ; Pagano, Salvatore ; Boccella, Serena ; Manzo, Iolanda ; Luongo, Livio ; Giorgini, Giada ; Guida, Francesca ; Belardo, Carmela ; Iannotta, Monica ; Maione, Sabatino ; Fusco, Antimo ; Marabese, Ida ; Silvestri, Cristoforo

There is a growing evidence suggesting the association of vitamin D deficiency (VDD) and cognitive impairment. In this study we evaluated the possible involvement of gut microbiota in the cognitive impairments mediated by VDD and investigated the effects of pharmacological treatment with the oxazoline derivative of the aliamide palmitoylethanolamide, 2-Pentadecyl-2-oxazoline (PEA-OXA). Mice were submitted to behavioural, biochemical and electrophysiological analysis to assess whether their vitamin D status affected cognitive performance together with gut microbiota composition. In VDD mice we found cognitive malfunctioning associated with reduced neuroplasticity, indicated by impaired long term potentiation, and neuroinflammation at the hippocampal level. Importantly, PEA-OXA counteracted the cognitive impairments and modified the biochemical and functional changes induced by VDD. Additionally, PEA-OXA treatment enhanced gut microbiota diversity, which tended to be decreased by VDD only in female mice, elevated the relative abundance of lactic and butyric acid-producing families, i.e. Aerococcaceae and Butyricicoccaceae, and reversed the VDD-induced decrease of butyrate-producing beneficial genera, such as Blautia in female mice, and Roseburia in male mice. These data provide novel insights for a better understanding of the cognitive decline induced by VDD and related gut dysbiosis and its potential therapeutic treatment.

01 Jun 2024·Nutrition

Palmitoylethanolamide and polydatin in pediatric irritable bowel syndrome: A multicentric randomized controlled trial

Article

Author: Felici, Enrico ; Bernardo, Luca ; Parisi, Pasquale ; Piccirillo, Marisa ; Coluzzi, Flaminia ; Furio, Silvia ; Evangelisti, Melania ; D'Angelo, Francesco ; Mennini, Maurizio ; Di Nardo, Giovanni ; Mauro, Angela ; Ferretti, Alessandro ; Cremon, Cesare ; Barbara, Giovanni ; Di Mari, Clelia

OBJECTIVEThis study aimed to evaluate the efficacy and safety of co-micronized palmitoylethanolamide (PEA)/polydatin (PD) in the treatment of abdominal pain symptoms in pediatric patients with irritable bowel syndrome (IBS).METHODSThis was a multicenter trial conducted at three Italian pediatric gastroenterology centers, employing a double-blind, placebo-controlled, parallel-arm design. Participants were ages 10 to 17 y and met Rome IV criteria for pediatric IBS. They were randomly allocated to receive either co-micronized PEA/PD or placebo, administered three times daily in a 1:1 ratio, over a 12-wk period. The study assessed baseline severity using the IBS-Severity Scoring System (IBS-SSS) at enrollment and after 4, 8, and 12 wk of treatment. Abdominal pain frequency was assessed on a scale from 1 to 7 d/wk, while stool consistency was classified using the Bristol Stool Scale (BSS) to categorize various IBS subtypes. The primary outcome was the percentage of patients who achieved complete remission, defined as IBS-SSS score <75 points after 12 wk of therapy.RESULTSThe study involved 70 children with IBS. Of the participants, 34 received co-micronized PEA/PD, and 36 received a placebo. As compared with the placebo group, the co-micronized therapy group had significantly more patients achieving complete remission after 12 wk (P = 0.015), with particular benefit in the IBS-diarrhea subtype (P = 0.01). The treatment group also experienced a significant reduction in abdominal pain intensity and frequency compared with the placebo group. No adverse events were recorded during the study period.CONCLUSIONSCo-micronized PEA/PD is a safe and effective treatment to treat abdominal pain symptoms in pediatric IBS.

01 May 2024·International Journal of Biological Macromolecules

CPPs-modified chitosan as permeability-enhancing chemotherapeutic combined with gene therapy nanosystem by thermosensitive hydrogel for the treatment of osteosarcoma

Article

Author: Cao, Jie ; Zhu, Chenghong ; Cao, Ziqi ; Ke, Xue

BACKGROUNDChemotherapy resistance of osteosarcoma (OS) is still the crux of poor clinical curative effect.E3 ubiquitin-protein ligase Rad18 (Rad18) contributed to doxorubicin resistance in OS, which ultimately mediated DNA damage tolerance and led to a poor prognosis and chemotherapy response in patients.METHODSIn this study, doxorubicin was loaded in the process of Fe²⁺ and siRad18 forming nanoparticles(FSD) through coordination, chitosan modified with cell penetrating peptide (H6R6) was synthesized and coated on the surface of the NPs(FSD-CHR). FSD-CHR was then dispersed in thermosensitive hydrogel(PPP) for peritumoral injection of osteosarcoma in situ. Subsequently, the physicochemical properties and molecular biological characteristics of the drug delivery system were characterized. Finally, an osteosarcoma model was established to study the anti-tumor effects of multifunctional nanoparticles and the immunotherapy effect combined with αPD-L1.RESULTSFSD-CHR has enhanced tumor tissue permeability, siRad18 can significantly reduce Dox-mediated DNA damage tolerance and enhance anti-tumor effects, and iron-based NPs show enhanced ROS upregulation. FSD-CHR@PPP showed significant inhibition of osteosarcoma growth in vivo and a reduced incidence of lung metastasis. In addition, siRad18 was unexpectedly found to enhance Dox-mediated immunogenic cell death (ICD).FSD-CHR@PPP combined with PD-L1 blocking significantly enhanced anti-tumor effects due to decreased PD-L1 enrichment.CONCLUSIONHydrogel encapsulation of permeable nanoparticles provides an effective strategy for doxorubicin-resistant OS, showing that gene therapy blocking DNA damage tolerance can enhance treatment response to chemotherapy and appears to enhance the effect of ICD inducers to activate the immune system.

News (Medical) associated with Palmitoylethanolamide

10 Apr 2024

·www.globenewswire.com

Clearmind Medicine Files U.S. Patent Application for Psychedelic-Based Treatment for Eating Disorders

Vancouver, Canada, April 10, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "company"), a clinical- stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has filed a patent application with United States Patent and Trademark Office (USPTO) for the use of 3-methylmethcathinone (with the chemical name 2-(methylamino)-1-(3-methylphenyl)-1-propanon) (“3-MMC”), to prevent and/or treat eating disorders either alone or in conjunction with Palmitoylethanolamide (“PEA”). “The field of weight loss has been a blockbuster of the pharmaceutical industry and generates billions of dollars to companies who are active in this space. We at Clearmind have made it our goal to be at the forefront of developments in fields where we believe that we have an advantage over the marketed treatments, with weight loss being one of them. With sort in supply, shortage of active ingredients, high price, adverse events and inconvenient method of administration, we believe that our molecules may have the potential over the ones already available “ A report by the World Obesity Federation, predicts that half the world will be overweight or obese by 2035. The report authors say this increase could put a strain on healthcare systems and cause $4 trillion in economic damage. About Clearmind Medicine Inc. Clearmind is a clinical- stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company’s intellectual portfolio currently consists of sixteen patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY0.” For further information visit: https://www.clearmindmedicine.com or contact: Investor Relations invest@clearmindmedicine.com Telephone: (604) 260-1566 US: CMND@crescendo-ir.com General Inquiries Info@Clearmindmedicine.com www.Clearmindmedicine.com Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its goal to be at the forefront of developments in fields where it believes that is has an advantage over the marketed treatments, with weight loss being one of them, and its belief that its molecules may have the potential over the ones already available. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2023 filed with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

27 Mar 2024

·www.globenewswire.com

Clearmind Medicine Announces International Patent Application for Preventing and Treating Depression

Vancouver, Canada, March 27, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY) (“Clearmind” or the “company”), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has submitted its tenth patent application under the international Patent Cooperation Treaty (“PCT”), as part of its ongoing collaboration with SciSparc Ltd. (Nasdaq: SPRC) (“SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system. The patent applications refer to the novel proprietary composition of Clearmind’s MEAI compound (5-methoxy-2-aminoindane) with Palmitoylethanolamide (“PEA”), the active ingredient of SciSparc’s proprietary CannAmide™, for preventing and/or treating depression. This application was previously filed as provisional patent application with the United States Patent and Trademark Office (“USPTO”). According to the ResearchAndMarkets.com, the global depression and anxiety disorders treatment market size was estimated to be USD 21.56 billion in 2023 and is expected to reach at USD 41.83 billion by 2034 with a CAGR of 6.21% during the forecast period 2024-2034. Overall, as part of this collaboration, nine other patent applications have been filed by Clearmind with the USPTO for various compositions, including the composition of SciSparc’s PEA with Clearmind’s MEAI compound for the treatments of alcohol use disorder, cocaine addiction and obesity and its related metabolic disorders. "We believe that traditional pharma has not taken an innovative approach to R&D as we have seen little innovation to SSRI's (selective serotonin reuptake inhibitors) and other anti-depressants in over 30 years. Under our collaboration with SciSparc, we believe that our proprietary drugs can positively impact patients dealing with various forms of depression including treatment resistant depression," stated Dr. Adi Zuloff-Shani, CEO of Clearmind. "We further believe that we have a tremendous opportunity to develop viable alternatives to the current SSRIs for individuals living with depression. We continue to execute our intellectual property strategy, to develop novel psychedelic drugs to address unmet mental health needs" continued Dr. Zuloff-Shani. About Clearmind Medicine Inc. Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company’s intellectual portfolio currently consists of fifteen patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY.” For further information visit: https://www.clearmindmedicine.com or contact: Investor Relationsinvest@clearmindmedicine.comTelephone: (604) 260-1566US: CMND@crescendo-ir.com General InquiriesInfo@Clearmindmedicine.comwww.Clearmindmedicine.com Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company I s using forward-looking statements when it discusses its belief that it has a tremendous opportunity to develop viable alternatives to the current SSRIs for individuals living with depression and that it continues to execute its intellectual property strategy, to develop novel psychedelic drugs to address unmet mental health needs. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2023 filed with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

Patent Expiration

27 Mar 2024

·www.globenewswire.com

SciSparc- Clearmind Collaboration Evolves with New International Patent Application for Preventing and Treating Depression

TEL AVIV, Israel, March 27, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced today that as part of its ongoing collaboration with Clearmind Medicine Inc. (“Clearmind”) (Nasdaq: CMND) (CSE: CMND) (FSE: CWY), a biotechnology company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, Clearmind has submitted a patent application under the international Patent Cooperation Treaty. The patent application refers to the novel proprietary composition of Clearmind’s MEAI compound (5-methoxy-2-aminoindane) with palmitoylethanolamide (“PEA”), the active ingredient of SciSparc’s proprietary CannAmide™, for preventing and/or treating depression. This application was previously filed as a provisional patent application with the United States Patent and Trademark Office (“USPTO”). According to the ResearchAndMarkets.com, the global depression and anxiety disorders treatment market size was estimated to be USD 21.56 billion in 2023 and is expected to reach at USD 41.83 billion by 2034 with a CAGR of 6.21% during the forecast period 2024-2034. Overall, as part of this collaboration, nine other patent applications have been filed by Clearmind with the USPTO for various compositions, including the composition of SciSparc’s CannAmide™with Clearmind’s MEAI compound for the treatment of alcohol use disorder, cocaine addiction and obesity and its related metabolic disorders. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on the Amazon.com Marketplace. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses the growth and expected size of the global depression and anxiety disorders treatment market. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on May 1, 2023, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Investor Contact:IR@scisparc.comTel: +972-3-6167055

Patent Expiration

100 Deals associated with Palmitoylethanolamide

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic musculoskeletal pain	NDA/BLA	CA	FSD Pharma, Inc.	19 Jan 2023
Chronic musculoskeletal pain	NDA/BLA	US	FSD Pharma, Inc.	19 Jan 2023
Chronic Pain	NDA/BLA	CA	FSD Pharma, Inc.	19 Jan 2023
Chronic Pain	Phase 2	US	FSD Pharma, Inc.	19 Jan 2023
Medium Chain Acyl CoA Dehydrogenase Deficiency	Phase 2	CA	FSD Pharma, Inc.	19 Jan 2023
COVID-19	Phase 2	US	FSD Pharma, Inc.	14 Dec 2020
Idiopathic mast cell activation syndrome	Phase 2	-	FSD Pharma, Inc.	-
Medium Chain Acyl CoA Dehydrogenase Deficiency	Phase 1	US	FSD Pharma, Inc.	19 Jan 2023
Inflammation	Phase 1	CA	FSD Pharma, Inc.	-
Inflammation	Phase 1	US	FSD Pharma, Inc.	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2019	Not Applicable	Chronic thromboembolic pulmonary hypertension	58	PEA plus MT and BPA	(wvyvxrhalp) = utkoklldav fqxwkxfvzo (fvhgfdefsr ) View more	-	02 Sep 2019
				MT plus BPA	(wvyvxrhalp) = higeqabamd fqxwkxfvzo (fvhgfdefsr ) View more
ISRCTN72647928 (Pubmed \| Invest Ophthalmol Vis Sci)	Not Applicable	Hypertension	40	Palmitoylethanolamide 300 mg	cuczniijts(ruyycvnmdv) = wabvynyaws owaatoaxfj (husaxcnqiq ) View more	Positive	01 Feb 2013
				Placebo	cuczniijts(ruyycvnmdv) = nruekugjkf owaatoaxfj (husaxcnqiq ) View more
ESC2021	Not Applicable	-	-	Palmitoylethanolamide combined with polydatin	xgpuligrsx(suojritorz) = xwteiqbldc vjaitxziqj (jymsuctsvf )	-	29 Jun 2021
				palmitoylethanolamide	xgpuligrsx(suojritorz) = ndvfggwmth vjaitxziqj (jymsuctsvf )
NCT03066193 (CTgov)	Phase 2	Tourette Syndrome	17	Palmitoylethanolamide+Dronabinol	lvycmlomjn(wjcrkloomg) = gslazyegoh vlnbjwgmhx (neruqncchr, nlpbmkgsdl - winjbmutfi) View more	-	19 Dec 2019
ISRCTN72647928 (ARVO2012)	Not Applicable	Hypertension	40	Palmitoylethanolamide	(ltdicotoph) = no side effects during the treatment period were observed xkvqoaeytc (ziahohnfpq )	-	01 Mar 2012
				Placebo
ESMO2022	Not Applicable	Inflammation	-	Palmitoylethanolamide	dzqrhpwcdz(yjanaybpxq) = ntehymsarg gxnotkbegl (byoicvdyrf )	-	10 Sep 2022
				Doxorubicin and trastuzumab	dzqrhpwcdz(yjanaybpxq) = biuupprmcl gxnotkbegl (byoicvdyrf )

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