[Translation] A randomized phase III clinical study comparing the efficacy and safety of glufosfamide and 5-fluorouracil (5-FU) in patients with metastatic pancreatic cancer who progressed after gemcitabine treatment

通过评估总生存期，评价与氟尿嘧啶(5-FU)相比，葡磷酰胺在既往接受过吉西他滨治疗的转移性胰腺腺癌患者中的疗效评价与氟尿嘧啶(5-FU)相比，葡磷酰胺在既往接受过吉西他滨治疗的转移性胰腺腺癌患者中的安全性

[Translation]

To evaluate the efficacy of glufosfamide compared with 5-FU in patients with metastatic pancreatic adenocarcinoma who have been previously treated with gemcitabine, by assessing overall survival To evaluate the safety of glufosfamide compared with 5-FU in patients with metastatic pancreatic adenocarcinoma who have been previously treated with gemcitabine

Start Date21 Oct 2022

Sponsor / Collaborator

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

NCT01954992

/ RecruitingPhase 3

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen.

Start Date01 Apr 2014

Sponsor / Collaborator

Eleison Pharmaceuticals, Inc.

NCT00441467

/ CompletedPhase 2

An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Primary Objective:
1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate
Secondary Objectives:
To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival
To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma
Exploratory Objectives:
To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET
To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Start Date01 Mar 2007

Sponsor / Collaborator

Eleison Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Glufosfamide

100 Translational Medicine associated with Glufosfamide

100 Patents (Medical) associated with Glufosfamide

Literatures (Medical) associated with Glufosfamide

31 Mar 2024·Aging

Identification and validation of ferroptosis-related gene SLC2A1 as a novel prognostic biomarker in AKI

Article

Author: Wang, Huaying ; Wu, Yonggui ; Li, Yuanyuan ; Liu, Xinran

BACKGROUND:

Emerging evidence reveals the key role of ferroptosis in the pathophysiological process of acute kidney injury (AKI). Our study aimed to investigate the potential ferroptosis-related gene in AKI through bioinformatics and experimental validation.

METHODS:

The AKI single-cell sequencing dataset was retrieved from the GEO database and ferroptosis-related genes were extracted from the GENECARD website. The potential differentially expressed ferroptosis-related genes of AKI were selected. Functional enrichment analysis was performed. Machine learning algorithms were used to identify key ferroptosis-related genes associated with AKI. A multi-factor Cox regression analysis was used to construct a risk score model. The accuracy of the risk score model was validated using receiver operating characteristic (ROC) curve analysis. We extensively explored the immune landscape of AKI using CIBERSORT tool. Finally, expressions of ferroptosis DEGs were validated in vivo and in vitro by Western blot, ICH and transfection experiments.

RESULTS:

Three hub genes (BAP1, MDM4, SLC2A1) were identified and validated by constructing drug regulatory network and subsequent screening using experimentally determined interactions. The risk mode showed the low-risk group had significantly better prognosis compared to high-risk group. The risk score was independently associated with overall survival. The ROC curve analysis showed that the prognosis model had good predictive ability. Additionally, CIBERSORT immune infiltration analysis suggest that the hub gene may influence cell recruitment and infiltration in AKI. Validation experiments revealed that SLC2A1 functions by regulating ferroptosis.

CONCLUSIONS:

In summary, our study not only identifies SLC2A1 as diagnostic biomarker for AKI, but also sheds light on the role of it in AKI progression, providing novel insights for the clinical diagnosis and treatment of AKI.

01 Dec 2021·Journal of the Egyptian National Cancer Institute

An in vitro cytotoxicity of glufosfamide in HepG2 cells relative to its nonconjugated counterpart

Article

Author: Rashidi, Fatma B ; Mohamed, Amr S ; Abdelhakim, Heba K ; Ahmed, Doaa E ; Arafa, Hossam M M

Abstract:

Background:

Glufosfamide (β-d-glucosylisophosphoramide mustard, GLU) is an alkylating cytotoxic agent in which ifosforamide mustard (IPM) is glycosidically linked to the β-d-glucose molecule. GLU exerted its cytotoxic effect as a targeted chemotherapy. Although, its cytotoxic efficacy in a number of cell lines, there were no experimental or clinical data available on the oncolytic effect of oxazaphosphorine drugs in hepatocellular carcinoma. Therefore, the main objective of the current study is to assess the cytotoxic potential of GLU for the first time in the hepatocellular carcinoma HepG2 cell line model.

Methods:

Cytotoxicity was assayed by the MTT method, and half-maximal inhibitory concentration (IC50) was calculated. Flow cytometric analysis of apoptosis frequencies was measured by using Annexin V/PI double stain, an immunocytochemical assay of caspase-9, visualization of caspase-3, and Bcl2 gene expression were undertaken as apoptotic markers. Mitochondrial membrane potential was measured using the potentiometric dye; JC-1, as a clue for early apoptosis as well as ATP production, was measured by the luciferase-chemiluminescence assay.

Results:

Glufosfamide induced cytotoxicity in HepG2 cells in a concentration- and time-dependent manner. The IC50 values for glufosfamide were significantly lower compared to ifosfamide. The frequency of apoptosis was much higher for glufosfamide than that of ifosfamide. The contents of caspase-9 and caspase-3 were elevated following exposure to GLU more than IFO. The anti-apoptotic Bcl2 gene expression, the mitochondrial membrane potential, and the cellular ATP levels were significantly decreased than in case of ifosfamide.

Conclusions:

The current study reported for the first time cytotoxicity activity of glufosfamide in HepG2 cells in vitro. The obtained results confirmed the higher oncolytic activity of glufosfamide than its aglycone ifosfamide. The generated data warrants further elucidations by in vivo study.

01 Feb 2021·Thrombosis researchQ3 · MEDICINE

Possible immune regulation mechanisms for the progression of chronic thromboembolic pulmonary hypertension

Q3 · MEDICINE

Article

Author: Liu, Min ; Wang, Ying ; Dong, Xingbei ; Zhong, Jiuchang ; Wan, Jun ; Yang, Yuanhua ; Zhai, Zhenguo ; Guo, Xiaojuan ; Li, Yidan ; Yang, Suqiao ; Li, Jifeng ; Kuang, Tuguang ; Gong, Juanni ; Miao, Ran

PURPOSE:

This study aimed to screen key genes significantly associated with chronic thromboembolic pulmonary hypertension (CTEPH) and predicted suitable drugs for the treatment of CTEPH from the perspective of immune cells.

METHODS:

The dataset GSE130391 was used for this analysis. Differentially expressed genes (DEGs) between the CTEPH and control groups were screened. Abundance of infiltrating immune cells was analyzed and immune-related DEGs were identified. Next, the circular RNA (circRNA)-micro RNA (miRNA)-mRNA network was constructed, followed by functional enrichment analysis. Then, the protein-protein interaction (PPI) network was constructed and drug-gene interactions were predicted. Finally, miRNA and circRNA prediction results were verified by our previously published studies.

RESULTS:

Five key immune cell-related DEGs [CD83 molecule (CD83), complement c5a receptor 1 (C5AR1), atypical chemokine receptor 1 (ACKR1), profilin 2 (PFN2), and solute carrier family 2 member 3 (SLC2A3)] were identified. Several circRNA-miRNA-mRNA interactions were obtained, including circ_0022342miR-503-5pSLC2A3 and circ_0002062miR-92b-3p/miR-92a-3pmannosidase alpha class 2A member 1 (MAN2A1). Immune cell for SLC2A3 was eosinophils and for MAN2A1 was regulatory T cells (Tregs). Additionally, Glufosfamide and Kifunensine might be suitable as candidate drugs for CTEPH treatment.

CONCLUSIONS:

SLC2A3 and MAN2A1 may be important genes for the pathogenesis of CTEPH. Possible immune regulation mechanisms in CTEPH may be circ_0022342miR-503-5pSLC2A3 and circ_0002062miR-92b-3p/miR-92a-3pMAN2A1. These results may be helpful for the diagnosis and treatment of CTEPH from the perspective of immunology.

News (Medical) associated with Glufosfamide

27 Feb 2025

·ir.bullfrogai.com

BullFrog AI and Eleison Pharmaceuticals Enter Agreement to Collaborate to Optimize Pivotal Phase 3 Trial

Eleison to leverage BullFrog Data Networks™ to enhance patient clustering and safety analysis in glufosfamide clinical trials GAITHERSBURG, Md., Feb. 27, 2025 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) (“BullFrog AI” or the “Company”), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced its entry into a collaboration agreement with Eleison Pharmaceuticals Inc. (“Eleison”), a Phase 3 oncology company focused on novel chemotherapeutic treatments for rare cancers. Under the terms of the agreement, BullFrog AI will provide access to its BullFrog Data Networks™ AI solution to enhance clinical trial efficiency and patient insights. Financial terms of the collaboration were not disclosed. “The integration of artificial intelligence in clinical trials represents a transformative shift in how pharmaceutical companies can de-risk drug development and optimize patient outcomes,” said Vin Singh, CEO of BullFrog AI. “We are thrilled to partner with Eleison to apply our bfLEAP® AI technology, which has the potential to refine patient selection, improve trial efficiency, and ultimately accelerate the path to market for life-saving therapies.” Through this collaboration, BullFrog AI will apply its proprietary BullFrog Data Networks™ solution, powered by the bfLEAP® platform, to analyze clinical data from Eleison’s ongoing Phase 3 trial and previous clinical studies of glufosfamide, an investigational treatment for pancreatic cancer. The platform will evaluate the current trajectory of the trial with respect to safety signals, extract predictive biomarkers for efficacy and safety performance from prior studies to support future trial design, and provide data-driven insights to optimize Eleison’s planned clinical trials for inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD). These insights are expected to streamline trial efficiency and improve decision-making for Eleison’s broader oncology pipeline. Glufosfamide is a third-generation alkylating agent designed for greater specificity and tumor uptake, with reduced systemic toxicities and side effects. It is currently being evaluated by Eleison in a pivotal Phase 3 international randomized clinical trial, for the second-line treatment of patients with pancreatic cancer. Although pancreatic cancer is among the rarer cancer types, it is the third leading cause of death by cancer in the United States. More than 67,000 Americans and 510,000 people worldwide are diagnosed with pancreatic cancer annually. Few therapeutic options exist to treat the disease and five-year survival rates are typically less than 5%. Eleison expects to complete this ongoing Phase 3 trial in 2027. “Our collaboration with BullFrog AI underscores our commitment to innovation in drug development,” said Edwin Thomas, CEO of Eleison. “By leveraging AI-powered analytics, we aim to generate deeper insights into patient responses and safety trends, which will not only benefit our glufosfamide program but also inform the strategic direction of our broader oncology pipeline.” About BullFrog AI BullFrog AI leverages Artificial Intelligence and machine learning to advance drug discovery and development. Through collaborations with leading research institutions, BullFrog AI uses causal AI in combination with its proprietary bfLEAP™ platform to analyze complex biological data, aiming to streamline therapeutics development and reduce failure rates in clinical trials. For more information, visit BullFrog AI at: https://bullfrogai.com About Eleison Pharmaceuticals Eleison’s mission is to acquire and develop drug candidates with existing and significant safety and efficacy data; and ultimately to obtain regulatory approval and commercialize new therapeutics for patients with life-threatening cancers. In addition to its glufosfamide program, the Company has two other programs in late-stage clinical development; ILC in development for small cell lung cancer and pediatric osteosarcoma, and DBD for brain cancers. The Company has entered into development and marketing partnerships with leading pharmaceutical companies in China, S. Korea, and Israel. Eleison was founded in 2009 and is headquartered in Princeton, NJ. Additional information about Eleison can be found at our website www.eleison-pharma.com. Safe Harbor Statement This press release contains forward-looking statements. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," “could,” “will,” "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur. Contact: Dave Gentry RedChip Companies, Inc. 1-407-644-4256 BFRG@redchip.com Released February 27, 2025

Phase 3

11 May 2006

·www.biospace.com

Threshold Pharmaceuticals, Inc. Reports First Quarter 2006 Financial Results

REDWOOD CITY, Calif., May 10 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. , today reported financial results for the first quarter ended March 31, 2006. The net loss for the first quarter of 2006 was $13.8 million compared to $7.5 million for the first quarter of 2005. Research and development expenses were $11.4 million for the first quarter of 2006 versus $5.3 million for the first quarter of 2005. The increase in research and development expenses primarily reflects increased costs of advancing the Company's product pipeline, including Phase 2 and Phase 3 multi-center clinical trials of TH-070 for the treatment of benign prostatic hyperplasia (BPH), an ongoing Phase 3 trial of glufosfamide for the second-line treatment of patients with pancreatic cancer and a Phase 2 trial of glufosfamide in combination with gemcitabine for the first-line treatment of pancreatic cancer. General and administrative expenses were $3.8 million for the first quarter of 2006 versus $2.6 million for the same quarter last year. The increase in general and administrative expenses primarily reflects increased costs associated with being a public company and stock compensation expense recognized under FAS 123(R). Total non-cash stock compensation expense for the Company was $3.0 million for the first quarter of 2006 versus $1.6 million for the first quarter of 2005. Approximately $1.3 million of the increase in non-cash stock compensation is a direct result of adopting FAS 123(R) on January 1, 2006 which requires public companies to expense employee stock awards based on a fair value. The Company recognized revenue of $0.4 million in the first quarter of 2006. As of March 31, 2006, Threshold had $87.4 million in cash and marketable securities. "We continued to achieve our clinical milestones with the completion of enrollment in both the Phase 2 and Phase 3 trials of TH-070 in BPH, and we expect to report the results of these trials around the beginning of the fourth quarter," said Barry Selick, Threshold's chief executive officer. "We are also on track to report results from the Phase 3 glufosfamide trial in second-line pancreatic cancer patients by the end of this year as well." Recent Highlights -- Completed enrollment of Phase 3 trial of TH-070 in BPH patients; -- Completed enrollment of Phase 2 trial of TH-070 in BPH patients; -- Presented positive Phase 1 data on glufosfamide plus gemcitabine in the first-line treatment of advanced solid tumors, including pancreatic cancer, at the American Society of Clinical Oncology (ASCO) 2006 Gastrointestinal Cancers Symposium; -- Continued to enroll patients in a Phase 3 trial of single-agent glufosfamide for second-line treatment of advanced pancreatic cancer; and -- Received important patents related to TH-070 and 2DG from the U.S. Patent and Trademark Office. The Company anticipates the following clinical milestones in 2006: -- Report results from ongoing Phase 2 and Phase 3 trials of TH-070 in BPH around the beginning of the fourth quarter of 2006; -- Report results from a Phase 3 trial of single-agent glufosfamide for second-line treatment of advanced pancreatic cancer by end of 2006; -- Commence three supportive trials with TH-070; and -- Commence at least one additional trial of glufosfamide in a new cancer indication. About Threshold Pharmaceuticals Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics in mid- and late-stage clinical trials for the potential treatment of benign prostatic hyperplasia (BPH), a disease afflicting tens of millions of men worldwide and cancer. By selectively targeting abnormally-proliferating tumor cells, the Company's drug candidates are designed to be potentially more effective and less toxic to healthy tissues than conventional treatments. For additional information, please visit our website ( ). Forward-Looking Statements Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates, clinical trial progress and results, and potential therapeutic uses and benefits of our product candidates. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to complete its anticipated clinical trials, the time and expense required to conduct such clinical trials, and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Annual Report on Form 10-K, which was filed with the Securities Exchange Commission on March 28, 2006 and is available from the SEC's website ( ) and on our website ( ) under the heading "Investors." We undertake no duty to update any forward-looking statement made in this news release. Contact: Denise T. Powell Carolyn Bumgardner Wang Sr. Director, Corporate Communications WeissComm Partners, Inc. Threshold Pharmaceuticals, Inc. 415-946-1065 650-474-8206 carolyn@weisscommpartners.comdpowell@thresholdpharm.com THRESHOLD PHARMACEUTICALS, INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2006 2005 Revenue $359 $-- Operating expenses Research and development 11,438 5,251 General and administrative 3,813 2,565 Total Operating Expenses 15,251 7,816 Loss from operations (14,892) (7,816) Interest and other income 1,072 284 Interest expense (6) (8) Net Loss $(13,826) $(7,540) Net loss per basic and diluted loss per common share $(0.38) $(0.46) Weighted-average shares used in computing basic and diluted loss per common share 35,949 16,340 THRESHOLD PHARMACEUTICALS, INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2006 2005 (unaudited) (1) Assets Cash, cash equivalents and marketable securities $87,447 $99,654 Prepaid expenses and other current assets 1,092 563 Property and equipment, net 2,389 1,667 Other assets 509 217 Total assets $91,437 $102,101 Liabilities and stockholders' equity Total current liabilities $9,846 $9,562 Long-term liabilities (2) 2,781 3,171 Stockholders' equity 78,810 89,368 Total liabilities and stockholders' equity $91,437 $102,101 (1) Derived from audited financial statements (2) Includes $2.5 million deferred revenue related to the development agreement with MedBIC Co. Ltd. Threshold Pharmaceuticals, Inc. CONTACT: Denise T. Powell, Sr. Director, Corporate Communications, ofThreshold Pharmaceuticals, Inc., +1-650-474-8206 ordpowell@thresholdpharm.com; or Carolyn Bumgardner Wang of WeissCommPartners, Inc., +1-415-946-1065 or carolyn@weisscommpartners.com, forThreshold Pharmaceuticals, Inc. Web site:

CollaborateFinancial StatementSmall molecular drugASCO

100 Deals associated with Glufosfamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	Glufosfamide	-	DB06177

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Cancer	Phase 3	United States	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Argentina	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Brazil	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Bulgaria	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Czechia	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Hungary	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	India	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Mexico	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Romania	Threshold Pharmaceuticals, Inc.	01 Sep 2004
Metastatic Pancreatic Cancer	Phase 3	Russia	Threshold Pharmaceuticals, Inc.	01 Sep 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00441467 (CTgov)	Phase 2	Locally Advanced Soft Tissue Sarcoma \| Soft Tissue Sarcoma	22	Glufosfamide	hugitxnlim = bwndfgamag tkmkhayknd (ulnqqqkkdr, xwjtzgvker - zayslowjmu) View more	-	02 Mar 2015
ASCO2007	Phase 2	Pancreatic adenocarcinoma	29	Glufosfamide 4500 mg/m2 + Gemcitabine 1000 mg/m2	kmrbnexpth(gclueztznl) = awkmfdnyxl vaevonlpuf (ornejnpays, 8 - 41) View more	-	20 Jun 2007
ASCO2006	Phase 1	HR-positive/HER2-low Solid Tumors	-	Glufosfamide	stcjirahso(fuimrmnwjd) = wyzxigilyx rzinjxfysb (mbdrgopllx )	-	20 Jun 2006
ASCO2004	Phase 2	Advanced breast cancer	22	Glufosfamide	qancutxokj(ilxgtczbuc) = cfgttzdpqk xrvdmmrsof (foyjbipeow ) View more	-	15 Jul 2004
Pubmed \| Eur J Cancer	Phase 2	Advanced Lung Non-Small Cell Carcinoma Second line	39	Glufosfamide	prkyrfnxgz(noclyzxaij) = zczkpczpgp cfeilcfoaf (xoaoszdlli, 4.2 - 7.9) View more	-	01 Mar 2004
Pubmed \| Eur J Cancer	Phase 2	Pancreatic Cancer First line	35	Glufosfamide	lbfrybqqlw(wvgsrgwqnf) = recorded in 5 patients zyfwxtlows (kllwmwsfec ) View more	Negative	01 Nov 2003

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