A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).

Start Date18 Dec 2023

Sponsor / Collaborator

SciTech Development LLC

NCT06181760 / CompletedPhase 1

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 / 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.

100 Clinical Results associated with Fenretinide

100 Translational Medicine associated with Fenretinide

100 Patents (Medical) associated with Fenretinide

1,041

Literatures (Medical) associated with Fenretinide

19 Apr 2024·ACS Chemical Biology

Lipid-Restricted Culture Media Reveal Unexpected Cancer Cell Sensitivities

Article

Author: Goldfarb, Ralston B ; Adams, Drew J ; Yan, David F ; Atala Pleshinger, Matthew J

Cancer cell culture models frequently rely on fetal bovine serum as a source of protein and lipid factors that support cell survival and proliferation; however, serum-containing media imperfectly mimic the in vivo cancer environment. Recent studies suggest that typical serum-containing cell culture conditions can mask cancer dependencies, for example, on cholesterol biosynthesis enzymes, that exist in vivo and emerge when cells are cultured in media that provide more realistic levels of lipids. Here, we describe a high-throughput screen that identified fenretinide and ivermectin as small molecules whose cytotoxicity is greatly enhanced in lipid-restricted media formulations. The mechanism of action studies indicates that ivermectin-induced cell death involves oxidative stress, while fenretinide likely targets delta 4-desaturase, sphingolipid 1, a lipid desaturase necessary for ceramide synthesis, to induce cell death. Notably, both fenretinide and ivermectin have previously demonstrated in vivo anticancer efficacy despite their low cytotoxicity under typical cell culture conditions. These studies suggest ceramide synthesis as a targetable vulnerability of cancer cells cultured under lipid-restricted conditions and reveal a general screening strategy for identifying additional cancer dependencies masked by the superabundance of medium lipids.

01 Mar 2024·Journal of Controlled Release

Rhamnose-PEG-induced supramolecular helices: Addressing challenges of drug solubility and release efficiency in transdermal patch

Article

Author: Ruan, Jiuheng ; Liu, Chao ; Wang, Jiaqi ; Song, Haoyuan ; Fang, Liang ; Cai, Yu ; Wang, Xiaoxu

Transdermal drug delivery systems (TDDS) demand both high drug loading capacity and efficient delivery. In order to improve both simultaneously, this study aims to develop a novel rhamnose-induced pressure-sensitive adhesive (HPR) by dispersing the drug in the supramolecular helical structure. Ten model drugs, categorized as acidic and basic compounds, were chosen to understand the characteristics of the HPR and its inner mechanism. Notably, it enhanced drug loading by 1.41 to 5 times over commercially available pressure-sensitive adhesives Duro-Tak@ 87-4098 and Duro-Tak@ 87-2287, in addition to increasing drug release efficiency by a factor of about 5. Pharmacokinetic evaluation demonstrated that the HPR group had >4-fold (Tulobuterol TUL) and 3-fold (Diclofenac DIC) more area under the blood drug concentration curve (AUC) than the commercial TUL and DIC patches in the absence of added excipients and a significantly prolonged mean residence time (MRT) of >4-fold (TUL) and 3-fold (DIC), demonstrating the potential for highly efficacious and prolonged dosing. Furthermore, its safety and mechanical properties meet the requisite standards. Mechanistic inquiries unveiled that both acidic and basic drugs establish hydrogen bonds with HPR and become encapsulated within supramolecular helical structures. The supramolecular helical structures, significantly elevated both the enthalpy of the drug-HPR and entropy of the drugs release, thereby substantially enhancing drug delivery efficiency. In summary, HPR enabled a significant simultaneous enhancement of drug loading and drug delivery, which, together with its unique spatial structure, would contribute to the development of TDDS. In addition, the establishment of rhamnose-induced supramolecular helical structures would provide innovative pathways for different drug delivery systems.

01 Feb 2024·YAKUGAKU ZASSHI

ビタミンAとその誘導体によるがんの予防と治療—細胞の分化と増殖—

Article

Author: Takahashi, Noriko

Normal differentiation and proliferation of cells are essential for maintaining homeostasis. Following the successful completion of whole genome sequencing, protein modification has been attracted increasing attention in order to understand the roles of protein diversification in protein function and to elucidate molecular targets in mechanisms of signal transduction. Vitamin A is an essential nutrient for health maintenance. It is present as β-carotene in green and yellow vegetables and retinyl ester in animal products and absorbed into the body from the intestines. After ingestion, it is converted to retinol and oxidized in target cells to retinal, which plays critical roles in vision. It is then further oxidized to retinoic acid (RA), which exhibits a number of effects prior to being metabolized by cytochrome P450 and excreted from the body. Since RA exhibits cell differentiation-inducing actions, it is used as a therapeutic agent for patients with acute promyelocytic leukemia. The current paper describes: (1) HL60 cell differentiation and cell differentiation induction therapy by RA; (2) roles played by RA and retinal and their mechanisms of action; (3) retinoylation, post-translational protein-modified by RA, a novel non-genomic RA mechanism of action without RA receptor; (4) new actions of β-carotene and retinol in vivo and (5) potent anticancer effects of p-dodecylaminophenol (p-DDAP), a novel vitamin A derivative created from the RA derivative fenretinide. We propose that nutritional management of vitamin A can be effective at preventing and treating diseases, and that p-DDAP is a promising anticancer drug.

News (Medical) associated with Fenretinide

20 Dec 2023

·www.prnewswire.com

SciTech Development Announces First Patient Dosed in Phase 1 Clinical Trial of ST-001

This study is designed to evaluate ST-001 for the treatment of T-cell non-Hodgkin's lymphoma (NHL). GROSSE POINTE, Mich., Dec. 20, 2023 /PRNewswire/ -- 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 dosed the first patient in its Phase 1 clinical trial with lead cancer drug candidate, ST-001 nanoFenretinide. ------------------------ Join us here to learn more about the Company and our science: ------------------------ "There have been relatively few new cancer breakthroughs for T-cell lymphoma in several years, so we are excited to announce this milestone for patients suffering from this rare disease." said Earle Holsapple, SciTech's President, and CEO. "Our scientific team has worked extremely hard to bring this new drug to the people that need it most. We currently have four active trial sites with world-renowned medical institutions in New York, California, Pennsylvania, and Michigan, with more sites coming onboard in early 2024 as the trials expand. SciTech is proud to be on the forefront of helping cancer patients and we thank everyone who has supported our journey." The active drug fenretinide has been clinically tested and deemed safe in over 3,000+ patients in previous clinical trials. However, due to bioavailability issues of past fenretinide formulations, high concentrations of the drug could not reach and kill the target cancer cells. SciTech led the effort to find the solution with its patented methods for phospholipids and nanoparticalization to enhance fenretinide's bioavailability, thus developing ST-001 nanoFenretinide. SciTech's Phase 1 clinical trials are targeting patients with T-cell non-Hodgkin's lymphoma, including Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides, Sézary Syndrome, and non-Cutaneous T-cell Lymphoma subtypes. The initial study will determine the Maximum Tolerated Dose (MTD) of ST-001 nanoFenretinide (IV infusion) in patients with CTCL and other T-cell non-Hodgkin's lymphoma. For more detailed trial information, please visit ClinicalTrials.gov; Identifier: NCT04234048. 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: Contact Information: David Schaffer Director; Business Development and Investor Relations [email protected] 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. SOURCE SciTech Development

Phase 1

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

03 Oct 2023

·www.prnewswire.com

SciTech Readies for First-In-Human Trial with Clinical Supply of ST-001 nanoFenretinide

GROSSE POINTE FARMS, Mich., Oct. 3, 2023 /PRNewswire/ --.SciTech announced today that it has successfully manufactured the clinical supply of its lead drug candidate, ST-001 nanoFenretinide, to initiate its upcoming clinical trial in T-cell non-Hodgkin lymphomas (NCT04234048). SciTech's contract drug manufacturing partner has successfully manufactured ST-001 under strict QA/QC quality standards. Through a combination of innovative science and advanced nanotechnology, SciTech has developed ST-001, a new and patented formulation that enables the safe and rapid infusion of high-dose fenretinide for cancer treatment. SciTech's Delivery Platform maximizes the bioavailability of water-insoluble drugs. ST-001 has passed extensive testing required for IV-administered drug products, including United States Pharmacopeia (USP) testing for sterility, endotoxins, particle sizing, and particulate matter as well as International Conference on Harmonization (ICH) guidelines for heavy metals and drug impurities. "SciTech is thrilled to announce the successful manufacturing of ST-001 as we begin our human clinical trials. This is another major milestone for the company. Our team and investors are passionate about bringing ST-001 to the market for the treatment of T-cell lymphomas and other broader indications," said Earle Holsapple, President of SciTech Development. "We know that both patients and clinicians are looking for innovative and cost-effective ways to solve this cancer epidemic. SciTech is proud to be part of the medical community offering a new therapeutic and a giant step forward to help conquer cancer." SciTech's specialized drug formulation increases the bioavailability of fenretinide, which allows more of the active drug to reach the cancer cells. ST-001 binds to the cancer cells and disrupts the nucleus, causing the cancer cells to die. With ST-001, our goal is to reduce drug-related toxicities and achieve optimal drug concentrations for better patient outcomes. To learn more, watch the video on How ST-001 Works. About SciTech Development SciTech Development LLC is a clinical-stage, specialty oncology pharmaceutical company that is revolutionizing how safe and promising yet challenged drugs can be delivered to kill cancer cells. SciTech's lead drug candidate, ST-001 nanoFenretinide is Phase 1 clinical trial-ready with IRB approvals, FDA Investigational New Drug (IND) approval, and is Orphan Drug designated. Our first clinical trials in T-cell Lymphomas are the gateway for additional trials, such as lung cancer, and in other disease indications for use as a broadly applicable anticancer drug. More information about SciTech can be found at . David Schaffer Director Investor Relations [email protected] SOURCE SciTech Development

Phase 1Orphan DrugIND

100 Deals associated with Fenretinide

External Link

KEGG	Wiki	ATC	Drug Bank
D04162	Fenretinide	-	DB05076

R&D Status

10 top R&D records.

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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
Non-Muscle Invasive Bladder Neoplasms	Phase 3	US	National Cancer Institute	30 Jul 1998
Oral Leukoplakia	Phase 3	US	National Cancer Institute	01 Jun 1997
Hormone receptor positive breast cancer	Phase 2	US	National Cancer Institute	01 Oct 1995
Carcinoma in situ of uterine cervix	Phase 2	US	National Cancer Institute	05 Mar 1993
Cervical Intraepithelial Neoplasia	Phase 2	US	National Cancer Institute	05 Mar 1993
Precancerous Conditions	Phase 2	US	National Cancer Institute	05 Mar 1993
Breast Cancer	Phase 1	-	Johnson & Johnson	-
Breast Cancer	Phase 1	-	Laurent Pharmaceuticals, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00104923 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Hematologic Neoplasms	29	Fenretinide	(ruvsiihyqc) = ghxmmiczwh hjqjniuxkj (nlnfzzqtot )	Positive	15 Aug 2017
				Fenretinide (patients with response-evaluable peripheral T-cell lymphomas)	(pgmuiwffvl) = whaxoeeitq wekybgtvap (sihdbxawha ) View more
NCT00295919 (ASCO2014)	Phase 1	Neuroblastoma	80	4-HPR/LXS oral powder	(aaojijzjsd) = zzgxobdgvv ymubwkptek (lzyghqxkcm, 1.35 - 36.9+) View more	-	20 May 2014
				Ketoconazole	fcxcgxakhn(msupcynvyl) = apuqejbryu vtogdqxtyk (enyfwrmflv, 14.6, 22.1)
NCT00288067 (Pubmed \| Int J Radiat Oncol Biol Phys) Manual	Phase 1/2	Mantle-Cell Lymphoma \| B-Cell Lymphoma	32	fenretinide	(mrygbjovod) = No dose-limiting toxicities were observed. aglwllneof (aijkvppzqi ) View more	Positive	01 Feb 2017
				fenretinide+rituximab
NCT03265288 (APPLAUD, Biospace) Manual	Phase 2	Cystic Fibrosis	166	LAU-7b	(ecvaprtswd): difference = 1.23	Positive	03 Nov 2022
				Placebo
ARVO2020	Not Applicable	-	-	Emixustat	(uubqwutqum) = neylrkqssj zmobfvkdgy (ydnpyifxrt )	-	01 Jun 2020
				Fenretinide	(uubqwutqum) = rhoqezznox zmobfvkdgy (ydnpyifxrt )
ARVO2012	Not Applicable	-	-	Fenretinide-treated mice	ycainqhmgy(nsmyjoqibu) = yevqbjjvsq oiskpwkgvl (eorayclgnp, 0.0004) View more	Positive	01 Mar 2012
				Fenretinide	ycainqhmgy(nsmyjoqibu) = elunfjqvjz oiskpwkgvl (eorayclgnp, 0.0009) View more
PhI-42 (ASCO2012)	Phase 1	Hematologic Neoplasms	25	Fenretinide (4-HPR) intravenous emulsion	eciocpdxlx(wotntcmbnm) = Reversible hypertriglyceridemia related to the intralipid vehicle accounted for 6/7 DLTs iaenegilpx (jbnahmtgsg )	-	20 May 2012
AACR2012	Phase 1	Neuroblastoma recurrent	-	4-HPR/LXS	aolfnlwggz(fndigetarh) = vpnsuxyrzt lohvwtrwii (fokshmwuab )	-	15 Apr 2012

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