A Phase 2 Open Label, Single Arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Squamous Cell Carcinoma (SCC)

The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.

Start Date12 Dec 2019

Sponsor / Collaborator

Stanford University

[+1]

ISRCTN17129075 / CompletedNot ApplicableIIT

The effectiveness of SLIM SHAPE 2.0 interventions in improving the health, wellness, and work productivity among the staff of Universiti Kebangsaan Malaysia

Start Date01 Oct 2019

Sponsor / Collaborator-

100 Clinical Results associated with Remetinostat

100 Translational Medicine associated with Remetinostat

100 Patents (Medical) associated with Remetinostat

Literatures (Medical) associated with Remetinostat

01 Jun 2023·Journal of labelled compounds & radiopharmaceuticals

Nitrilase mediated mild hydrolysis of a carbon-14 nitrile for the radiosynthesis of 4-(7-hydroxycarbamoyl-[1-C-heptanoyl]-oxy)-benzoic acid methyl ester, [C]-SHP-141: A novel class I/II histone deacetylase (HDAC) inhibitor

Article

Author: Moody, Thomas S ; Chappell, Todd ; Kitson, Sean L ; Watters, William ; Mazitschek, Ralph

A strategy has been developed for the carbon-14 radiosynthesis of [¹⁴C]-SHP-141, a 4-(7-hydroxycarbamoyl-heptanoyloxy)-benzoic acid Me ester derivative containing a terminal hydroxamic acid.The synthesis involved four radiochem. transformations.The key step in the radiosynthesis was the conversion of the 7-[¹⁴C]-cyano-heptanoic acid benzyloxyamide [¹⁴C]-4 directly into the carboxylic acid derivative, 7-benzyloxycarbamoyl-[¹⁴C]-heptanoic acid [¹⁴C]-8 using nitrilase-113 biocatalyst.The final step involved deprotection of the benzyloxy group using catalytic hydrogenation to facilitate the release of the hydroxamic acid without cleaving the phenoxy ester. [¹⁴C]-SHP-141 was isolated with a radiochem. purity of 90% and a specific activity of 190 μCi/mg from four radiochem. steps starting from potassium [¹⁴C]-cyanide in a radiochem. yield of 45%.

01 Jan 2023·Current Topics in Medicinal Chemistry

Recent Advances in Chemical Composition and Transdermal Delivery Systems for Topical Bio-actives in Skin Cancer

Review

Author: Mishra, Ajit ; Kar, Biswakanth ; Rath, Goutam ; Halder, Jitu ; Ghosh, Goutam

Abstract:Skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma, is conventionally treated by surgery, phototherapy, immunotherapy, and chemotherapy. For decades, surgical removal of malignant cancers has favored patients' therapeutic options. However, multiple aspects, such as the patient's comorbidities, the anatomical location of the lesion, and possible resistance to recurrent excisions, can influence the decision to conduct surgery. Therefore, topical and transdermal therapy may be a more appropriate option, allowing for higher therapeutic levels at the site of action and reducing toxicity than systemic therapy. The most commonly used topical agents for treating skin carcinoma are- 5-fluorouracil, imiquimod, sonidegib, dacarbazine, etc. However, drug physicochemical characteristics and skin physiological barriers limit the anticancer potency of topical as well as transdermal drug delivery. In recent years, unquestionable signs of progress have been demonstrated to circumvent these challenges. In particular, significant studies have been made, including modification of bio-actives, permeability enhancers, incorporation of advanced nano and microcarriers, and physical enhancement devices. This critical review summarizes the advancement in the chemical composition of bioactives used in skin cancer, such as sinecatechins, BIL-010t, patidegib, gingerol, curcumin, remetinostat, epigallocatechin-3-gallate, etc. Furthermore, this review, specifically addresses the progress in transdermal delivery systems for melanoma and non-melanoma cancer therapy, emphasizing advances in physical and chemical penetration enhancement and nanocarrier-assisted transdermal systems.

01 Jan 2022·JAMA DermatologyQ1 · MEDICINE

Treatment of Cutaneous Squamous Cell Carcinoma With the Topical Histone Deacetylase Inhibitor Remetinostat

Q1 · MEDICINE

Letter

Author: Sarin, Kavita Y. ; Bailey, Irene ; Eichstadt, Shaundra ; Shah, Aatman ; Kilgour, James M. ; Aasi, Sumaira Z.

News (Medical) associated with Remetinostat

15 Feb 2023

·www.biospace.com

Medivir AB - Year-End Report January - December 2022

HUDDINGE, Sweden, Feb. 15, 2023 /PRNewswire/ -- Continued strong recruitment in the dose escalation part of the fostrox study. October – December Financial summary for the quarter Net turnover amounted to SEK 2.3 (13.9) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -17.9 (-23.5) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.44) and SEK -0.32 (-0.44) respectively. Cash flow from operating activities amounted to SEK -24.7 (-5.4) million. Cash and cash equivalents at the end of the period amounted to SEK 117.4 (221.2) million. Significant events during the quarter In October the nomination committee was appointed ahead of the 2023 AGM. The Nomination Committee consists of Karl Tobieson (Chairman), appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB. Pia Baumann was recruited in November as new Chief Medical Officer, taking office in February 2023. Medivir presented new data, showing additive efficacy of fostrox in combination with anti-PD1 in experimental tumor models, at the SITC Immunotherapy Conference in November. Medivir completed a pre-IND meeting with the US Food and Drug Administration and received positive feedback on the development plan in preparation for an IND for its candidate drug fostrox. January – December Financial summary for the period Net turnover amounted to SEK 4.4 (25.5) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -84.8 (-59.5) million. Basic and diluted earnings per share amounted to SEK -1.59 (-1.20) and SEK -1.59 (-1.20) respectively. Cash flow from operating activities amounted to SEK -101.8 (-48.7) million. Cash and cash equivalents at the end of the period amounted to SEK 117.4 (221.2) million. Significant events after the end of the period On January 11 it was announced that Medivir's partner Infex Therapeutics has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) for MET-X, the company's broad spectrum Metallo-beta-lactamase inhibitor (MBLI) based on Medivir's MBLI program. Conference call for investors, analysts and the media The Year-End Report January - December 2022 will be presented by Medivir's CEO, Jens Lindberg. Time: Wednesday, February 15, 2023, at 14.00 (CET). Phone numbers for participants from: Sweden + 46 8 505 163 86 Europe +44 20 3198 4884 US +1 412-317 6300 Pin code 1872625# The conference call will also be streamed via a link on the website: The presentation will be available on Medivir's website after completion of the conference. CEO's message Taking over as CEO of Medivir in January 2022, I was given the privilege of leading a great team to develop cancer medicines that can really make a difference. Our main focus in 2022 has been the continued clinical development of Medivir's proprietary candidate drug fostroxacitabine bralpamide (fostrox). Fostrox has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action in liver cancer makes fostrox attractive to combine with several other drugs for the treatment of hepatocellular carcinoma HCC. The combination study is progressing as expected in ongoing dose escalation cohorts. The measures taken to accelerate patient recruitment at the end of the summer had the desired effect. Since then, interest in the study has been very high, with patients standing in line waiting for new cohorts to be opened. We look forward to shortly establishing the recommended dose for the first combination arm and subsequently initiating the phase 2a portion of the study. We have also presented new data for fostrox during the year. At the EASL Liver Cancer Summit in February, Medivir was able to present biomarker data from the phase 1 study with fostrox which, among other things, shows that fostrox provides a tumor-selective effect in the liver by causing the desired DNA damage and cell death in tumor cells in the liver but not in normal or healthy liver cells. At the SITC Immunotherapy Conference in November, Medivir presented new data showing that the combination of fostrox with anti-PD1 provides an improved effect in experimental tumor models and creates changes in the tumor microenvironment consistent with increased immune-mediated antitumor activity. It is also gratifying that we, at our pre-IND meeting with the US Food and Drug Administration FDA in December, received positive feedback on the IND preparation program for fostrox. We plan to submit an IND application to the US authority in 2023. In Medivir's business development, we focus on our two clinical projects for partnership, remetinostat and MIV-711. The data packages for both projects have been strengthened during the year and we continue our dialogues with external parties in order to find the best possible solution for each substance. Medivir's clinical project birinapant was out-licensed to IGM Biosciences in 2021. IGM is conducting ongoing clinical development work with the phase I clinical study in solid tumors with birinapant in combination with IGM's own DR5 agonist antibody IGM-8444. As of Q4 2022, IGM reported that the fourth dose-escalation cohort was ongoing and no dose-limiting toxicities were observed to date. Medivir's preclinical research program USP-1 was out-licensed in 2020 to US-based Tango Therapeutics, which announced that it has selected TNG348, a USP-1 inhibitor from this research program, as a development/drug candidate in the treatment of BRCA1/2 mutated cancers. Tango intends to open an IND in the US in 2023 for TNG348. Also our preclinical program MBLI aimed at addressing the threat of resistant bacteria appears to be moving towards clinical development. It is licensed to INFEX Therapeutics in England, which recently received QIDP-designation from the FDA and communicated its intention to initiate a phase 1 program in 2023. I would like to take this opportunity to wish our new CMO Pia Baumann a warm welcome to the team. Pia is a cancer specialist with solid experience in global drug development, which will be very valuable in the continued clinical development of fostrox. We are glad to note the strong interest in fostrox and that the measures taken have yielded results in patient recruitment for the soon-to-be-completed phase 1b part of the study. Our work to ensure that fostrox can become an effective drug against liver cancer continues unabated. We hope and believe that it will lead to a treatment that makes a real difference for the patients and for the care and thus also for our shareholders. I look forward to keeping you informed of Medivir's continued development. Jens Lindberg Chief Executive Officer For further information, please contact Magnus Christensen, CFO Phone: +46 (0)8 5468 3100 E-mail: magnus.christensen@medivir.com This report has not been subject to auditors' review. The information was submitted for publication at 08.30 CET on February 15, 2023. The following files are available for download: View original content: SOURCE Medivir Company Codes: Stockholm:MVIRB, Bloomberg:MVIRB@SS, ISIN:SE0000273294, RICS:MVIRB.ST

Phase 1Executive ChangeFinancial Statement

03 Nov 2022

·www.prnewswire.com

MEDIVIR AB - INTERIM REPORT JANUARY - SEPTEMBER 2022

STOCKHOLM, Nov. 3, 2022 /PRNewswire/ -- The measures to increase the pace of patient recruitment have yielded results. The Fostrox study is now progressing as expected. July – September Financial summary for the quarter Net turnover amounted to SEK 1.1 (0.8) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -13.9 (-11.7) million. Basic and diluted earnings per share amounted to SEK -0.27 (-0.24) and SEK -0.27 (-0.24) respectively. Cash flow from operating activities amounted to SEK -19.7 (-20.0) million. Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million. Significant events during the quarter Fostroxacitabine bralpamide – the name given to MIV-818 by the World Health Organization (WHO) – received formal approval as a pharmaceutical name in the USA by the United States Adopted Names (USAN) Council. January – September Financial summary for the period Net turnover amounted to SEK 2.1 (11.6) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -66.9 (-36.0) million. Basic and diluted earnings per share amounted to SEK -1.27 (-0.75) and SEK -1.27 (-0.75) respectively. Cash flow from operating activities amounted to SEK -77.1 (-43.3) million. Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million. Events after the end of the period In October the nomination committee was appointed ahead of the AGM in May 2023. The Nomination Committee consists of Karl Tobieson (Chairman), appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB. Conference call for investors, analysts and the media The Interim Report January - September 2022 will be presented by Medivir's CEO, Jens Lindberg. Time: Thursday, November 3, 2022, at 15.00 (CET). Phone numbers for participants from: Sweden + 46 8 505 583 65 Europe +44 33 3300 9269 US +1 631 913 1422, pin code 19436682# The conference call will also be streamed via a link on the website: The presentation will be available on Medivir's website after completion of the conference. CEO's message Our measures to regain momentum in patient recruitment have been effective and the fostrox study is now progressing as expected. Medivir's absolute focus is on the continued clinical development of our cutting-edge project fostroxacitabine bralpamide (fostrox), for the treatment of hepatocellular carcinoma (HCC). I described in our Q2 report that we saw slower recruitment to the study than expected in the second quarter, mainly in Europe. In order to increase recruitment speed, we decided for example to activate additional study centers and increase our presence at already activated trial centers. It is now very gratifying to state that the measures we initiated to speed up patient recruitment to the study have borne fruit. Today, a total of 14 centers are activated in the UK, Spain and South Korea and during Q3 we have seen an accelerated recruitment rate. Fostrox has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action in liver cancer enables attractive combination treatments with other drug alternatives for HCC. Medivir's strategy, to combine fostrox with other treatments, is well in line with the development within HCC, a development where improved clinical effect has been obtained by combining different types of medications. Despite these advances, the medical needs in liver cancer are still significant. Far from all patients benefit from existing therapy options, and therefore many combination studies are underway to find treatments that significantlyimproves the outcome for HCC patients. We have good hopes that fostrox with its liver-directed mechanism of action is an innovative combination concept that can contribute to more powerful treatments and we have chosen to work in parallel with two combinations. In the end, we will choose the most attractive combination to proceed with in phase 2b based both on the clinical results of the study and how the treatments are actually applied in cancer care. Our preparations to open an Investigational New Drug (IND) in the USA in 2023 is progressing according to plan. The continued focus for our business development lies on our two clinical projects for partnerships, remetinostat and MIV-711. The data packages for these two projects have been strengthened during 2021–2022 and we continue our dialogue with external parties with the ambition of finding the best possible solution for each substance. Regarding our out-licensed projects, IGM Bioscience's clinical development work is progressing in the phase I clinical study in solid tumors with birinapant in combination with IGM's own DR5 agonist antibody IGM-8444. Three dose-escalation cohorts have been completed with no dose-limiting toxicity or clinically significant hepatotoxicity observed to date. Patient recruitment to the fourth dose escalation cohort in the study is ongoing. In summary, we see that the measures we have taken have yielded results in patient recruitment for our ongoing combination study with fostrox. We continue our work tirelessly so that fostrox can become an effective drug against liver cancer that makes a real difference for patients and for care and thus also for our shareholders. I look forward to keeping you informed of Medivir's continued development. Jens Lindberg Chief Executive Officer For further information, please contact Magnus Christensen, CFO Phone: +46 (0)8 5468 3100 E-mail: [email protected] This report has been subject to auditors' review. The information was submitted for publication at 08.30 CET on November 3, 2022. The following files are available for download: SOURCE Medivir

Antibody

03 Nov 2022

·www.biospace.com

Medivir AB - Interim Report January - September 2022

STOCKHOLM, Nov. 3, 2022 /PRNewswire/ -- The measures to increase the pace of patient recruitment have yielded results. The Fostrox study is now progressing as expected. July – September Financial summary for the quarter Net turnover amounted to SEK 1.1 (0.8) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -13.9 (-11.7) million. Basic and diluted earnings per share amounted to SEK -0.27 (-0.24) and SEK -0.27 (-0.24) respectively. Cash flow from operating activities amounted to SEK -19.7 (-20.0) million. Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million. Significant events during the quarter Fostroxacitabine bralpamide – the name given to MIV-818 by the World Health Organization (WHO) – received formal approval as a pharmaceutical name in the USA by the United States Adopted Names (USAN) Council. January – September Financial summary for the period Net turnover amounted to SEK 2.1 (11.6) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -66.9 (-36.0) million. Basic and diluted earnings per share amounted to SEK -1.27 (-0.75) and SEK -1.27 (-0.75) respectively. Cash flow from operating activities amounted to SEK -77.1 (-43.3) million. Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million. Events after the end of the period In October the nomination committee was appointed ahead of the AGM in May 2023. The Nomination Committee consists of Karl Tobieson (Chairman), appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB. Conference call for investors, analysts and the media The Interim Report January - September 2022 will be presented by Medivir's CEO, Jens Lindberg. Time: Thursday, November 3, 2022, at 15.00 (CET). Phone numbers for participants from: Sweden + 46 8 505 583 65 Europe +44 33 3300 9269 US +1 631 913 1422, pin code 19436682# The conference call will also be streamed via a link on the website: The presentation will be available on Medivir's website after completion of the conference. CEO's message Our measures to regain momentum in patient recruitment have been effective and the fostrox study is now progressing as expected. Medivir's absolute focus is on the continued clinical development of our cutting-edge project fostroxacitabine bralpamide (fostrox), for the treatment of hepatocellular carcinoma (HCC). I described in our Q2 report that we saw slower recruitment to the study than expected in the second quarter, mainly in Europe. In order to increase recruitment speed, we decided for example to activate additional study centers and increase our presence at already activated trial centers. It is now very gratifying to state that the measures we initiated to speed up patient recruitment to the study have borne fruit. Today, a total of 14 centers are activated in the UK, Spain and South Korea and during Q3 we have seen an accelerated recruitment rate. Fostrox has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action in liver cancer enables attractive combination treatments with other drug alternatives for HCC. Medivir's strategy, to combine fostrox with other treatments, is well in line with the development within HCC, a development where improved clinical effect has been obtained by combining different types of medications. Despite these advances, the medical needs in liver cancer are still significant. Far from all patients benefit from existing therapy options, and therefore many combination studies are underway to find treatments that significantlyimproves the outcome for HCC patients. We have good hopes that fostrox with its liver-directed mechanism of action is an innovative combination concept that can contribute to more powerful treatments and we have chosen to work in parallel with two combinations. In the end, we will choose the most attractive combination to proceed with in phase 2b based both on the clinical results of the study and how the treatments are actually applied in cancer care. Our preparations to open an Investigational New Drug (IND) in the USA in 2023 is progressing according to plan. The continued focus for our business development lies on our two clinical projects for partnerships, remetinostat and MIV-711. The data packages for these two projects have been strengthened during 2021–2022 and we continue our dialogue with external parties with the ambition of finding the best possible solution for each substance. Regarding our out-licensed projects, IGM Bioscience's clinical development work is progressing in the phase I clinical study in solid tumors with birinapant in combination with IGM's own DR5 agonist antibody IGM-8444. Three dose-escalation cohorts have been completed with no dose-limiting toxicity or clinically significant hepatotoxicity observed to date. Patient recruitment to the fourth dose escalation cohort in the study is ongoing. In summary, we see that the measures we have taken have yielded results in patient recruitment for our ongoing combination study with fostrox. We continue our work tirelessly so that fostrox can become an effective drug against liver cancer that makes a real difference for patients and for care and thus also for our shareholders. I look forward to keeping you informed of Medivir's continued development. Jens Lindberg Chief Executive Officer For further information, please contact Magnus Christensen, CFO Phone: +46 (0)8 5468 3100 E-mail: magnus.christensen@medivir.com This report has been subject to auditors' review. The information was submitted for publication at 08.30 CET on November 3, 2022. The following files are available for download: View original content: SOURCE Medivir Company Codes: Bloomberg:MVIRB@SS, ISIN:SE0000273294, RICS:MVIRB.ST, Stockholm:MVIRB

Antibody

100 Deals associated with Remetinostat

External Link

KEGG	Wiki	ATC	Drug Bank
D10977	Remetinostat	-	DB14869

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous Cell Carcinoma	NDA/BLA	US	Stanford University School of Medicine	09 Nov 2019
Cutaneous T-Cell Lymphoma	Phase 2	-	Tetraphase Pharmaceuticals, Inc.	-
Squamous Cell Carcinoma	Discovery	US	Stanford University School of Medicine	09 Nov 2019
Basal Cell Carcinoma	Discovery	US	Medivir AB	07 Jul 2018
Alopecia Areata	Discovery	-	TetraLogic Pharmaceuticals Corp.	01 Feb 2017
Plaque psoriasis	Discovery	AU	TetraLogic Pharmaceuticals Corp.	01 Sep 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03180528 (Pubmed \| Clin Cancer Res) Manual	Phase 2	Basal Cell Carcinoma	25	Remetinostat	(esptdgsudt) = awbdirlkyx jntwapfkvu (ifvxjcrptz ) View more	Positive	01 Sep 2021
NCT03875859 (CTgov)	Phase 2	Squamous Cell Carcinoma	4	Remetinostat	ykibegfzvw(vfwpbnzjje) = vstukwveay ngqfzkdotd (yzsnmtigza, snuapivmvu - bggrihqdbn) View more	-	20 May 2021
NCT03180528 (CTgov)	Phase 2	Basal Cell Carcinoma	30	Remetinostat	(swtmvwitxc) = vdynczxpif gsmbesxitw (qhympkjtcd, eaobkardew - cywrpkgnsc) View more	-	05 Jan 2021
NCT01433731 (ASCO2014) Manual	Phase 1	Cutaneous T-Cell Lymphoma	18	SHP-141	(zrgnnvwjgj) = mdxbmrupfb pznqxeoznv (ejifrdeops ) View more	Positive	20 May 2014
NCT01433731 (ASCO2014) Manual	Phase 1	Cutaneous T-Cell Lymphoma	18	placebo	(zrgnnvwjgj) = qxtgszqkur pznqxeoznv (ejifrdeops ) View more	Positive	20 May 2014

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