A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules in Healthy Adult Volunteers

The goal of this clinical trial is to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions it aims to answer are: •How well is a single dose of fenretinide tolerated? AND •How is a single dose of fenretinide metabolized in healthy volunteers?
Participants will be asked to:
Remain confined in a clinical research unit for 5 days after dosing.
Provide blood samples for intense PK sampling and safety labs.
Fast for 10 hours prior to administration of study drug (fasted cohorts).
Consume a high fat meal prior to administration of study drug (fed cohort).
Return to the clinic for a single follow-up visit for safety assessments. Researchers will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.

Start Date22 Nov 2023

Sponsor / Collaborator

Island Pharmaceuticals Ltd.

NCT05999435 / Active, not recruitingPhase 2/3

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE PHASE 2/3 STUDY OF THE EFFICACY OF LAU-7b IN THE TREATMENT OF ADULTS WITH LONG COVID AND MODERATE TO SEVERE SYMPTOMS

ESSOR is a double-blind, placebo-controlled study of the orally-administered antiviral and inflammation-controlling LAU-7b for the treatment of adults with Long COVID and moderate to severe symptoms.

Start Date20 Nov 2023

Sponsor / Collaborator

Laurent Pharmaceuticals, Inc.

NCT04417257 / CompletedPhase 2/3

RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease

A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.

Start Date29 Jun 2020

Sponsor / Collaborator

Laurent Pharmaceuticals, Inc.

100 Clinical Results associated with Fenretinide

100 Translational Medicine associated with Fenretinide

100 Patents (Medical) associated with Fenretinide

1,053

Literatures (Medical) associated with Fenretinide

01 Nov 2024·Anticancer Research

Immunoliposomes for Neuroblastoma: Review of the Past Experience and Design of a Novel Nanoparticle

Review

Author: Panosyan, William S ; Panosyan, Daniel E

BACKGROUND/AIMHigh-risk/refractory neuro-blastoma (NBL) treatments include anti-GD2-monoclonal antibodies (mAbs). Several immunoliposomes (ILs) covered with anti-GD2-mAbs (GD2-ILs) have been tested pre-clinically. We aimed to review literature on GD2-IL for characteristics of nanoparticles/payloads, conjugation of mAb/fragments and preclinical data, as well as to explore the feasibility of a recently proposed GD2-IL loaded with the antimetabolite oxamate.MATERIALS AND METHODSInitial PubMed search was generalized for immunoliposomes in cancer. Further search was focused on papers for GD2-IL [keywords: "Immunoliposomes and cancer (or neuroblastoma)"].RESULTSThere were 811 results on "immunoliposomes"; >50% were on "immunoliposomes, cancer" (n=439, June 2024). Seventeen items resulted from "immunoliposomes, neuroblastoma" (one was "publishers' correction"). Sixteen GD2-IL references were reviewed (1993-current). The mean±SD GD2-ILs size was 124.8±31 nm (range=86-171). Six papers described GD2-ILs with DNA-damaging agents [doxorubicin (n=4), etoposide (n=1), irinotecan+HDAC inhibitor (n=1)]. Other payloads included: fenretinide (n=4 papers), C-myb antisense (n=2), survivin inhibitor (n=1), tyrosine kinase inhibitor (n=1), IL15 (n=1), and oxamate (n=1). These 9 drug-loads included both hydrophilic and hydrophobic molecules. Except for IL15 and C-myb antisense with high molecular weights (MWs), and oxamate with low MW, the remaining compounds had comparable MWs (496±100 g/mol, range=349-588.6). The overall encapsulation efficiency was 66.2±25.6%. There were 17-30 mAb molecules attached to an IL with PEGylation. Experiments with GD2-positive/GD2-negative cells demonstrated selective efficacy/tropism of GD2-ILs. Mouse models confirmed efficacy, GD2-specific tumor accumulation, decreased toxicity, and improved pharmacokinetic-pharmacodynamics.CONCLUSIONPEGylated anti-GD2-IL may allow NBL tropism. A size of approximately 100 nm could allow vascular permeability and packaging of oxamate in amounts needed for profound/selective lactate dehydrogenase-A inhibition. Thus, oxamate-loaded GD2-ILs may allow exploring the great translational potential of Warburg effect inhibition in GD2-positive cancers.

02 Oct 2024·Journal of Chemotherapy

Prognostic and immunological values of SKA3 for overall survival in lung adenocarcinoma and its RNA binding protein involved mechanisms

Article

Author: Gu, Yinfeng ; Guan, Hongjun ; Li, Jinjin ; Sun, Changpeng

This article aimed to investigate the correlations among SKA3 expression and prognosis, clinical relevance, tumor immunity, and RNA-binding protein (RBP)-involved mechanisms for overall survival (OS) in lung adenocarcinoma (LUAD). To explore the SKA3 expression level in LUAD by analyzing the genomic data as well as related clinical characteristics from the database of TCGA. Nomogram and gene set enrichment analysis (GSEA) were applied, respectively, to evaluate the performance of SKA3 in LUAD. Correlations between SKA3 and immunity and RBP-involved mechanisms were also performed. SKA3 had a higher expression level in LUAD samples than in adjacent normal lung samples, with shorter survival times in the high-SKA3-expressed LUAD subgroup (P < 0.05). qRT-PCR results remained consistent (P < 0.05). Uni-/multivariate Cox analyses revealed that SKA3 could have independent prognostic ability for LUAD (both P < 0.05). The nomogram model constructed with clinical pathological parameters and SKA3 expression levels predicted OS rates for LUAD and GSEA revealed SKA3-related pathways. In aspects of tumor immunity, SKA3 was significantly involved with tumor neoantigen burden, tumor mutational burden, immune cell pathways, and immune checkpoint inhibitor (ICI) molecules (all P < 0.05). The CellMiner database also found significant correlations between SKA3 and the antitumor drug sensitivity of chemotherapy, fenretinide, and PX-316. Besides, a total of nine LncRNA/RBP/SKA3 networks were revealed in LUAD for their RBP-involved mechanisms. SKA3 could serve as a potential biomarker for OS prognosis and immunotherapy in LUAD. LncRNA/RBP/SKA3 networks were identified in LUAD for their RBP-involved mechanisms, paving the way for further experimental verifications.

01 Oct 2024·Journal of Controlled Release

Novel lipid nanovesicle-loaded dissolving microarray patches for fenretinide in breast cancer chemoprevention

Article

Author: Naser, Yara A ; Vora, Lalitkumar K ; Hutton, Aaron R J ; Lopes, Luciana B ; Sabri, Akmal H ; Donnelly, Ryan F ; Li, Mingshan ; Volpe-Zanutto, Fabiana ; McCarthy, Helen O ; Apolinário, Alexsandra Conceição

The retinoid fenretinide (FENR) is a promising compound for preventing breast cancer recurrence but faces challenges due to poor solubility and low bioavailability. This study explores the development of dissolving microneedles (MNs) containing FENR-loaded ethosomes for minimally invasive breast cancer chemoprevention, aiming to enhance local drug distribution. Ethosomes were formulated using ethanol, propylene glycol, soya lecithin, water, and polysorbate 80 micelles. MNs were created from poly(vinyl alcohol) and poly(vinylpyrrolidone) hydrogels by adding polymer powder directly into ethosomes suspensions, reducing manufacturing time and cost. Two methods were used to load ethosomes into high-density moulds: 1) only in the needle area, and 2) in both the needle area and baseplate. Dynamic light scattering confirmed nanostructures in the hydrogels and MNs. Micelle-based ethosomes dissolved MNs in 15 min, compared to 30 min for other MNs. Skin deposition studies showed greater drug deposition (up to 10 μg/patch) and enhanced skin permeation of FENR (up to 40 μg) with Method 2. In-vivo studies in rats demonstrated that oral administration resulted in plasma FENR levels below 10 ng/g in the first three hours, whereas MN administration delayed delivery, reaching a maximum plasma concentration of 52 ng/g at 48 h. Skin deposition of FENR from MNs decreased from 3 μg/g on day 1 to <0.3 μg/g by the last day. This study indicates that MNs are a potential minimally invasive dosage form for delivering FENR, offering a new approach for breast cancer chemoprevention.

News (Medical) associated with Fenretinide

26 Oct 2023

·www.prnewswire.com

SciTech Development Announces The Formation of a Distinguished Medical Advisory Board With Top Oncology Specialists

GROSSE POINTE FARMS, Mich., Oct. 26, 2023 /PRNewswire/ -- SciTech Development, LLC, today announced the formation of a distinguished and independent medical advisory board (MAB) comprised of key opinion leaders and world-renowned experts in T-Cell Lymphomas and hematological malignancies. The board will provide strategic and clinical advice for SciTech's outreach and education initiatives within the oncology community. Continue Reading SciTech Medical Advisory Board "SciTech is excited and incredibly proud that this world-class group of medical experts will assist us with innovative insights that enable us to bring ST-001 to patients who have limited options in their cancer treatments," said President and Managing Partner Earle Holsapple. "The clarity they bring in understanding the clinical needs of patients will serve to guide us through the commencement of our phase 1 clinical trial and through our subsequent expedited clinical program." The three medical advisors appointed to the board are Madeleine Duvic, M.D., Larisa Geskin, M.D., and Ajay Gopal, M.D. Madeleine Duvic, MD – "The development of ST-100 is exciting because this new drug holds the promise of improved bioavailability, leading to increased efficacy with low toxicity." Dr. Duvic is a Professor of Medicine and Dermatology practices in Houston, Texas, and holds the Blanche Bender Endowed Chair of Research. Her clinical research includes translational/molecular studies leading to improved therapies for cutaneous T-cell lymphomas. She has written over 500 peer-reviewed papers and a book on Retinoids. She participated in the development of topical and oral tazarotene and bexarotene which both received FDA approval. Larisa J. Geskin, MD, FAAD - "I am thrilled to support SciTech's innovative approach to cancer therapeutics. SciTech's patented nanoparticle platform, SDP, enhances the effectiveness and safety of fenretinide, which has shown promise in treating patients with incurable cutaneous lymphomas in preliminary studies. SciTech's flagship product, ST-001, stands out for its ability to deliver therapeutic doses without toxic side effects, greatly benefiting our patients." Dr. Geskin is a Professor of Dermatology (in Medicine, Division of Hematology-Oncology) at Columbia University Medical Center and the Director of the Comprehensive Cutaneous Oncology Center at the Columbia University Department of Dermatology. Dr. Geskin serves as the Immediate Past-President of the International Society for Cutaneous Lymphomas (ISCL), the Secretary-Treasurer of the US Cutaneous Lymphomas Consortium (USCLC), and the Founding Chair of the New York Cutaneous Lymphoma Consortium (NYCLC), among her many other responsibilities. Ajay K. Gopal, MD - "Based on the encouraging preclinical data from a variety of laboratories, our observed tolerability of fenretinide, and the unmet need in a spectrum of malignancies novel formulations such as ST-001 nanoFenretinide are certainly worthy of further investigation." Dr. Gopal received his undergraduate degree from Duke University and his MD from Emory University. He completed his internal medicine training at Duke University School of Medicine and his oncology training at the University of Washington and Fred Hutchinson Cancer Center, where he currently holds an endowed chair and serves as a Professor and Clinical Research Director for Hematologic Malignancies. Dr. Gopal has over 2 decades of experience in the development of novel therapies for lymphoma, as reflected by over 200 publications in the field, including the first translational and clinical trial data evaluating fenretinide in lymphoma. Contact: Earle Holsapple Email: [email protected] About SciTech Development SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a new drug product with potentially broad effectiveness in many cancers. For more information about the Company, please visit: SOURCE SciTech Development

Phase 1Executive Change

14 Sep 2023

·www.biospace.com

SciTech Development Announces IRB Approval for Human Clinical Trials

Lead cancer drug candidate, ST-001 nanoFenretinide, has received Institutional Review Board ("IRB") approval for its upcoming clinical trials for T-Cell Lymphomas. GROSSE POINTE FARMS, MI / ACCESSWIRE / September 14, 2023 / SciTech Development ("SciTech" or the "Company"), a clinical-stage pharmaceutical company with a novel and patented drug delivery platform, today announced that the company has received IRB approval for its clinical trial protocol for their lead cancer drug candidate, ST-001 nanoFenretinide. SciTech Development ------------------------ Join us here to follow the Company: ------------------------ SciTech is pleased to announce that it has received central IRB approval from WCG to enter the clinic at the University of Pittsburgh Medical Center. USC Keck Medicine also granted SciTech local IRB approval to enter the clinic. Additional clinical sites will be added as the trials expand. ST-001 has FDA Investigational New Drug (IND) approval, orphan drug designation, and is Phase 1 clinical trial ready. An Institutional Review Board (IRB) is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects. IRB approval is a critical and necessary prerequisite to commencing human clinical trials and serves an important role in the protection of the rights and welfare of human research subjects. WCG is the world's largest independent centralized Institutional Review Board with over 200 IRB experts, servicing more than 800 institutions, with hundreds of active sites around the world. "The IRB approval of our accelerated T-Cell Lymphoma trial protocol is an important step that allows us to move forward with recruitment for our Phase 1 clinical trial," commented Earle Holsapple, SciTech's President and CEO. "We are excited to initiate this important study as there have been relatively few new cancer breakthroughs for T-Cell Lymphomas in several years." About SciTech Development SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a broadly applicable anticancer drug. For more information about the Company, please visit: Safe Harbor - Forward-Looking Statement: This document contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding attempts to identify new products, services or strategic opportunities which may include a strategic transaction, plans regarding partnering activities, service pricing or financial forecasts. Such statements are only predictions, and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that the Company may not be able to identify acceptable strategic opportunities or conclude any identified strategic transaction, the risk that products or services that appeared promising in early use do not demonstrate the same utility in larger-scale uses or trials, the risks associated with the Company's reliance on outside financing to meet its capital requirements, and the risks associated with the Company's reliance on forward-looking contracts. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted, or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underly the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, political, environmental, competitive, and/or other material risks. Contact Information David Schaffer Director Investor Relations drs@scitechdevelopment.com SOURCE: SciTech Development View source version on accesswire.com:

Orphan DrugINDPhase 1Clinical StudyCell Therapy

07 Jun 2023

·www.prnewswire.com

SciTech Development Raises $2.73 Million in Oversubscribed Financing Round to Advance Clinical Trials for Cancer Treatment

-- Financing Provides for the Advancement of Clinical Trials – GROSSE POINTE FARMS, Mich., June 7, 2023 /PRNewswire/ -- SciTech Development today announced it has closed a $2.73M funding round, led by several prominent life science investors to advance clinical trials for Non-Hodgkin Lymphoma and Small Cell Lung Cancer. SciTech's capital investment is led by life science investors Storm Lake Capital (SLC), HRN Family Office, The National Foundation for Cancer Research (NFCR), along with Pointe Angels and other accredited investors. This funding round will accelerate SciTech's first clinical trials of ST-001 nanoFenretinide for the treatment of T-Cell Non-Hodgkin Lymphoma. In addition, SciTech is commencing a second $3M Convertible Note Round (CNR), and a $14M Series A raise as the Company approaches the dosing of the first set of patients in the upcoming clinical trials. "HRN family office focuses on investing in the Biotech and MedTech sectors, with a focus on the oncology and therapeutics space. We believe SciTech's dedication to developing cancer treatments for patients, combined with their utilization of advanced nanotechnology, make them an attractive partner for companies seeking to expand their oncology pipelines," said Salvatore M. Buscemi, CEO, and Co-Founding Partner at HRN, LLC. "SciTech has a remarkable team, and their journey has been incredible. We're proud to have supported them from day one. With this new group of institutional investors and their strong track record in life sciences, we believe there's no limit to what SciTech can accomplish." ST-001 is SciTech's patented, nanoparticle-formulated lead drug candidate, which has achieved a breakthrough in solving the bioavailability issues of the drug fenretinide without system-related toxicities. Drug shipment of ST-001 is expected in Q3 2023, with initial trials set to begin shortly thereafter. (ClinicalTrials.gov Identifier: NCT04234048). A Phase 1 clinical trial for Small Cell Lung Cancer will follow immediately after the T-Cell Non-Hodgkin Lymphoma trial. "We've been overwhelmed by the interest from the investor community and are glad to welcome some incredible investors to join us as we take the next major leap. Our investors clearly understand the magnitude of our Phase 1a/b trials and the speed at which we're moving to get ST-001 to patients with cancer. Every minute counts," said Earle Holsapple, President of SciTech Development. "We are confident that our relationships with current and future investors will grow as we move forward, not only with ST-001 but with other drugs in our pipeline." About SciTech Development SciTech Development LLC is a specialty pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines the delivery system with fenretinide as a broadly applicable cancer-fighting drug. ST-001 has FDA Investigational New Drug (IND) approval and Orphan Drug designation. More information about SciTech can be found at SOURCE SciTech Development

Phase 1Orphan Drug

100 Deals associated with Fenretinide

External Link

KEGG	Wiki	ATC	Drug Bank
D04162	Fenretinide	-	DB05076

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Post Acute COVID 19 Syndrome	Phase 3	CA	Laurent Pharmaceuticals, Inc.	20 Nov 2023
COVID-19	Phase 3	US	Laurent Pharmaceuticals, Inc.	29 Jun 2020
Kidney Neoplasms	Phase 2	US	National Cancer Institute	01 Dec 2000
Small cell lung cancer recurrent	Phase 2	US	National Cancer Institute	01 Nov 2000
Oral Leukoplakia	Phase 2	US	National Cancer Institute	01 Jun 1997
Hormone receptor positive breast cancer	Phase 2	US	National Cancer Institute	01 Oct 1995
Carcinoma in Situ	Preclinical	US	National Cancer Institute	01 Dec 1997
Breast Cancer	Preclinical	-	Laurent Pharmaceuticals, Inc.	-
Breast Cancer	Preclinical	-	Johnson & Johnson	-
Ovarian Epithelial Carcinoma	Discovery	US	National Cancer Institute	01 Sep 2001

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03265288 (APPLAUD, CTgov)	Phase 2	Cystic Fibrosis	166	LAU-7b (LAU-7b)	vvonqcimkn(crkuqlhkyc) = cbcwznuupw ouwxnvaqks (kvitvwkrmu, tgdspcbdze - sgmovnknye) View more	-	09 Oct 2024
				Placebo oral capsule (Placebo)	vvonqcimkn(crkuqlhkyc) = xebniiirfo ouwxnvaqks (kvitvwkrmu, prsqqqwexg - zyoshzpriw) View more
NCT03265288 (APPLAUD, Biospace) Manual	Phase 2	Cystic Fibrosis	166	LAU-7b	(jssrrwectb): difference = 1.23, P-Value = 0.0486	Positive	03 Nov 2022
				Placebo
NCT00546455 (CTgov)	Phase 2	Insulin Resistance \| Hepatitis \| Obesity \| Metabolic dysfunction-associated steatotic liver disease	21	Fenretinide (A- Fenretinide)	jzgcszxjvw(jpjmozbcju) = huobxeyfpm koanwpvrmg (yamnotdktk, jiuvamupuw - cdtlqoaymr) View more	-	10 Feb 2021
				placebo (B-Placebo)	jzgcszxjvw(jpjmozbcju) = ehuhpjhcdd koanwpvrmg (yamnotdktk, intelgzrru - ciwmqhpsvp) View more
NCT00288067 (Pubmed \| Int J Radiat Oncol Biol Phys) Manual	Phase 1/2	Mantle-Cell Lymphoma \| B-Cell Lymphoma	32	fenretinide	(whxobgwzlq) = No dose-limiting toxicities were observed. hhxgujjbrz (ldcqnweomu ) View more	Positive	01 Feb 2017
				fenretinide+rituximab
NCT00295919 (N2004-04, ASCO2014)	Phase 1	Neuroblastoma	80	4-HPR/LXS oral powder	(rhewknmkpu) = chxrnmulnh iunkalufmm (atvjmvfdnu, 1.35 - 36.9+) View more	-	20 May 2014
				Ketoconazole	uenmrngbiu(mwsnhlraoi) = iiqcrlbvie sidkjgbnnx (mrwdzrihjl, 14.6 - 22.1)
PhI-42 (ASCO2012)	Phase 1	Hematologic Neoplasms	25	Fenretinide (4-HPR) intravenous emulsion	ivxlhuaeqg(ihljzjyvhj) = Reversible hypertriglyceridemia related to the intralipid vehicle accounted for 6/7 DLTs toipgyxcpq (vukvyijzkt )	-	20 May 2012
AACR2012	Phase 1	Neuroblastoma recurrent	-	4-HPR/LXS	covrsvkybr(shlsxgbizn) = jitmhzvggo dyivhezoig (iwaxvwayts )	-	15 Apr 2012
NCT00429936 (ARVO2011)	Phase 2	Geographic Atrophy serum retinol binding protein	-	Fenretinide	(kavbbrtbdb) = ttupeabxlm fqapxuqssm (bbrzjxerav ) View more	-	01 Apr 2011
				Placebo	(kavbbrtbdb) = cqmjzdzdxo fqapxuqssm (bbrzjxerav ) View more
ARVO2011	Not Applicable	Retinal Degeneration	-	Brimonidine	zuilacibim(dpxsugmhxh) = lbltjpkqku imcqtpgjgo (axunzpyhqy ) View more	-	01 Apr 2011
				Fenretinide	zuilacibim(dpxsugmhxh) = qrykplkngy imcqtpgjgo (axunzpyhqy ) View more
NCT00077402 (Pubmed \| Cancer Chemother Pharmacol)	Phase 2	Castration-Resistant Prostatic Cancer	27	Fenretinide	kgobfjfzbo(mimiojomxs) = tnunhdnfca hklypppmiw (atbwnxzhpa, 19 - 73) View more	Negative	01 Oct 2010

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