To observe the safety and tolerability of epothilone B injection in patients with advanced solid tumors, evaluate the pharmacokinetic characteristics of epothilone B injection in humans, and explore the relationship between the dose of epothilone B injection and pharmacokinetic parameters and safety. To evaluate possible therapeutic effects and provide a reference for Phase II clinical trials.

Start Date05 Dec 2016

Sponsor / Collaborator

Hunan Dinuo Pharmaceutical Co. Ltd.

CTR20131989

/ CompletedPhase 1

埃坡霉素B 注射液人体安全性、耐受性与药代动力学的I 期临床试验

[Translation] Phase I clinical trial of safety, tolerability and pharmacokinetics of epothilone B injection in humans

观察埃坡霉素B 注射液在晚期实体瘤患者中的安全性及耐受性，确定埃坡霉素B 静脉注射给药在人体中的最大耐受剂量（MTD）。同时进行埃坡霉素B 注射液在人体中的药代动力学研究，评价药代动力学特征；探讨埃坡霉素B 注射液剂量、药代动力学参数和安全性的关系和可能出现的疗效反应，为Ⅱ期临床试验推荐安全合理的剂量和用药方案。

[Translation]

To observe the safety and tolerability of epothilone B injection in patients with advanced solid tumors and determine the maximum tolerated dose (MTD) of epothilone B intravenous administration in humans. At the same time, conduct a pharmacokinetic study of epothilone B injection in humans to evaluate its pharmacokinetic characteristics; explore the relationship between epothilone B injection dose, pharmacokinetic parameters and safety and possible efficacy responses, and recommend safe and reasonable doses and medication regimens for Phase II clinical trials.

Start Date07 Nov 2011

Sponsor / Collaborator

Hunan Dinuo Pharmaceutical Co. Ltd.

NCT00715013

/ CompletedPhase 1/2IIT

Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.

Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.
* Trial with medicinal product

Start Date01 Jul 2008

Sponsor / Collaborator

University of Zurich

100 Clinical Results associated with Patupilone

100 Translational Medicine associated with Patupilone

100 Patents (Medical) associated with Patupilone

627

Literatures (Medical) associated with Patupilone

01 Apr 2026·NEUROPHARMACOLOGY

Brain-penetrant microtubule-stabilizer epothilone B delays isoflurane-induced unconsciousness in mice

Article

Author: Yu, Xinyue ; Zeng, Xiran ; Huang, Yixiang ; Lee, Sophia ; Chang, Abbie ; Qiu, Zitong ; Wiest, Michael C

Inhalational anesthetics are currently believed to cause unconsciousness by acting on multiple molecular targets including neural ion channels, receptors, mitochondria, synaptic proteins, and cytoskeletal proteins. Inhalational anesthetics including isoflurane bind to cytoskeletal microtubules (MTs), potentially contributing to causing unconsciousness. This possibility is supported by our demonstration of isoflurane resistance in rats treated once with the brain-penetrant MT-stabilizing drug epothilone B (epoB), and by a recent study in mice using a similar drug given daily over two weeks, which found increased sensitivity to isoflurane. To further characterize the contribution of MTs as functionally relevant targets of volatile anesthetics in mice, we measured latencies to loss of righting reflex (LORR) under isoflurane in mice injected once subcutaneously with vehicle or epoB. We found significantly increased LORR latencies (i.e., anesthetic resistance) in 8 mg/kg epoB-treated mice on the day following injection, with reduced effects on subsequent days. The 29-s within-subject increase in LORR latencies is not large compared to the variability among different animals, but it represents a statistically large within-subject effect as represented by a Cohen's d of 0.8. The effect could not be accounted for by tolerance from repeated exposure to isoflurane. Our results support that binding of the inhalational anesthetic isoflurane to MTs contributes to LORR in mice, as it does in rats. Our findings support the Orchestrated Objective Reduction (Orch OR) model that posits consciousness as a property of a quantum physical state of neural MTs. We also discuss possible sex differences in anesthetic mechanisms suggested by our data.

11 Dec 2025·Nature

In situ structural mechanism of epothilone-B-induced CNS axon regeneration

Article

Author: Alvarez-Brecht, Pelayo ; Taira, Kenichiro ; Bodakuntla, Satish ; Mizuno, Naoko ; Yamada, Yurika ; Martinez-Sanchez, Antonio ; Biertümpfel, Christian ; Zhang, Rui ; Basnet, Nirakar ; Cada, A King

Abstract:

Axons in the adult central nervous system (CNS) do not regenerate following injury, in contrast to neurons in the peripheral nervous system and neuronal growth during embryonic development. The molecular mechanisms that prevent regeneration of neurons in the CNS remain largely unknown 1,2 . Here, to address the intracellular response to injury, we developed an in situ cryo-electron tomography and cryo-electron microscopy platform to mimic axonal damage and present the structural mechanism underlying thalamic axon regeneration induced by the drug epothilone B. We observed that stabilized microtubules extend beyond the injury site, generating membrane tension and driving membrane expansion. Cryo-electron microscopy reveals the in situ structure of microtubules at 3.19 Å resolution, which engage epothilone B within the microtubule lattice at the regenerating front. During repair, tubulin clusters are delivered and incorporated into polymerizing microtubules at the regenerating site. These microtubule shoots serve as scaffolds for various types of vesicles and endoplasmic reticulum, facilitating the supply of materials necessary for axon repair until membrane tension normalizes. We demonstrate the unexpected ability of neuronal cells to adjust to strain induced by epothilone B, which creates homeostatic imbalances and activates axons to regeneration mode.

01 Dec 2025·FUNCTIONAL & INTEGRATIVE GENOMICS

Construction of a prognostic model for hepatocellular carcinoma based on necrosis by sodium overload-related genes and identification of ANKRD13B as a new prognostic marker

Article

Author: Tan, Yi ; Zhang, Yigang ; Shi, Yilun ; Qu, Xiangyu ; Kong, Lianbao ; Wang, Suchen ; Zhu, Deming

Hepatocellular carcinoma (HCC), a prevalent malignant tumor of the digestive tract worldwide, is characterized by poor prognosis and high mortality rates. Necrosis by sodium overload (NECSO) represents a novel form of cell death that has been implicated in various cancer types. However, its functional role in HCC pathogenesis remains poorly understood. We conducted a co-expression analysis of the NECSO-associated gene TRPM4, followed by clustering analysis and weighted gene co-expression network analysis (WGCNA) to identify NECSO-related genes. Through evaluation of 101 distinct machine learning algorithm combinations, we developed prognostic models for HCC, with the optimal model selected based on the highest mean concordance index (C-index) across training and validation cohorts. Patients were stratified into high-risk and low-risk groups according to computed risk scores. Subsequent analyses compared intergroup differences in biological functions, immune microenvironment characteristics, and therapeutic responses to immunotherapy and chemotherapy. To identify pivotal biomarkers, we employed three feature selection methodologies: LASSO, SVM-RFE, and random forest algorithms. The biological significance of the identified core gene ANKRD13B was experimentally validated through in vitro cellular experiments. Using a correlation coefficient (cor) > 0.6, we identified 78 co-expressed genes. Subsequent clustering analysis of HCC samples based on these genes revealed 1,402 NECSO-associated genes. Further WGCNA, differential expression, and prognostic analyses of these genes yielded 31 prognostically genes. Among 101 machine learning combinations, the StepCox[both] combined with GBM algorithm emerged as the optimal prognostic model, achieving the highest mean C-index across training and validation cohorts. Survival analysis confirmed significantly poorer prognosis in the high-risk group. Receiver operating characteristic (ROC) curve analysis demonstrated good predictive performance. Functional enrichment revealed distinct intergroup biological profiles, with the high-risk group and the low-risk group showing enrichment in immune-related pathways, metabolic regulation, and cell death mechanisms. Notably, the high-risk group exhibited enhanced immune activation status and superior response rates to immune checkpoint inhibitors therapy. Correlation analyses established significant associations between model genes/risk scores and cell death genes, including ferroptosis, pyroptosis, cuproptosis, and disulfidptosis. Drug sensitivity analysis identified eight chemotherapeutic agents with heightened sensitivity in high-risk patients: BI.2536, Bleomycin, Cisplatin, Doxorubicin, Epothilone B, Gemcitabine, Mitomycin C, and Paclitaxel. In vitro validation confirmed ANKRD13B promoted the proliferation, invasion and migration of HCC. We established a novel NECSO prognostic model demonstrating good predictive capacity for HCC prognosis and therapeutic responsiveness. This model helps with personalized clinical management.

News (Medical) associated with Patupilone

14 Sep 2022

·www.globenewswire.com

MediciNova Receives Issue Notification for a New Patent Covering MN-166 (ibudilast) for the Treatment of Glioblastoma

LA JOLLA, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received an Issue Notification from the U.S. Patent and Trademark Office for a new patent which covers MN-166 (ibudilast) for the treatment of glioblastoma. This new patent is expected to expire no earlier than February 2039. The allowed claims cover a method of treating a patient diagnosed with glioblastoma or recurrent glioblastoma, wherein the patient expresses unmethylated MGMT, using MN-166 (ibudilast) in combination with one or more other therapeutic agents including temozolomide (TMZ), carmustine, bevacizumab, procarbazine, hydroxyurea, irinotecan, lomustine, nimotuzumab, sirolimus, mipsagargin, cabozantinib, onartuzumab, patupilone (epothilone B), and recombinant oncolytic poliovirus (PVS-RIPO). The allowed claims cover a wide range of doses of MN-166 (ibudilast) as well as the other therapeutic agents. The allowed claims also cover different types of glioblastoma including classical glioblastoma, proneural glioblastoma, mesenchymal glioblastoma, and neural glioblastoma. Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, “We are very pleased to receive the issue notification for this new patent as it offers additional coverage compared to our other two patents covering glioblastoma. We have an ongoing clinical trial of MN-166 in combination with temozolomide for the treatment of recurrent glioblastoma at the Dana-Farber Cancer Institute, Harvard Medical School. Results of our glioblastoma animal model study showed that median survival was longer in the group that received combination treatment with MN-166 plus temozolomide compared to the group that received the standard treatment of temozolomide alone, and this data was presented at the American Society of Clinical Oncology (ASCO) annual meeting. Encouragingly, the FDA granted orphan-drug designation to MN-166 as adjunctive therapy to temozolomide for the treatment of glioblastoma based on this data.” About Glioblastoma According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy. About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2021 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT:Geoff O'BrienVice PresidentMediciNova, Inc.info@medicinova.com

Radiation TherapySmall molecular drugASCOCollaborateIPO

27 May 2010

·www.pharmatimes.com

Novartis’ patupilone fails as ovarian cancer treatment

Novartis has suffered a setback with the news that a late-stage trial of its investigational prostate cancer treatment patupilone has failed to meet its primary endpoint. The Swiss major says that patupilone, also known as EPO906, did not show a significant overall survival advantage in a Phase III trial of patients with advanced ovarian cancer who were refractory or resistant to platinum-based therapy The comparator arm in the study was Johnson & Johnson’s Doxil/Caelyx (pegylated liposomal doxorubicin). The study, conducted in 168 sites in 22 countries, saw 829 patients randomly assigned to intravenous patupilone (10 mg/m2) once every three weeks or Doxil (50 mg/m2) once every four weeks and were evaluated for disease status by scans every eight weeks until disease progression. Novartis did not give any details about secondary endpoints included progression-free survival, safety and overall response rate but noted that no new or unexpected serious adverse events in the patupilone arm were identified in the trial. However, the company said it does not plan to proceed with regulatory filings based on these data. Still, this may not be end of the road for the compound, which belongs to a class of microtubule stabilisers called epothilones. It is still being evaluated in ongoing trials in multiple tumour types, including metastatic colorectal cancer, brain metastases in non-small cell lung cancer and hormone-refractory prostate cancer. Analysts had not held out any great hopes for patupilone but Novartis had expected to file the drug for ovarian cancer this year, giving special mention to the compound at a presentation of its oncology pipeline in December.

100 Deals associated with Patupilone

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fallopian Tube Carcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	Denmark	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	Finland	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	France	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	Greece	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	Italy	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	Poland	Novartis Pharmaceuticals Corp.	01 Nov 2005
Fallopian Tube Carcinoma	Phase 3	South Africa	Novartis Pharmaceuticals Corp.	01 Nov 2005

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00450866 (CTgov)	Phase 2	Breast Carcinoma Metastatic in the Brain \| Neoplasm Metastasis \| Breast Cancer	55	Epothilone B (Epothilone B: Group A)	prkfgzlbrz = zgduamjbjr gsyrhnfxan (iwrthlofgs, xdnuolyudt - ktlmsysfsr) View more	-	09 Oct 2013
NCT00450866 (CTgov)	Phase 2		55	Epothilone B (Epothilone B: Group B)	prkfgzlbrz = umlhguygaz gsyrhnfxan (iwrthlofgs, bmvkiabesv - hfixvndaat) View more	-	09 Oct 2013
AAN 12013 \| AAN 22013	Phase 2	Non-Small Cell Lung Cancer \| Brain metastases	50	Patupilone 10mg/m2	ttcxabpior(ktnivzaxtl) = dnphuzxfrt hcsgmejole (jifceozcwa, 10 - 40) View more	Positive	12 Feb 2013
AAN 12013 \| AAN 22013	Phase 2	Non-Small Cell Lung Cancer \| Recurrent Non-Small Cell Lung Cancer \| Brain metastases	50	Patupilone 10mg/m2	qfgynlntbh(awxalnjqup) = fxxxsybanl lsaejewmis (dvejhjngln, 10 - 40) View more	Positive	12 Feb 2013
NCT00262990 (Pubmed \| J Clin Oncol)	Phase 3	Platinum-Resistant Primary Peritoneal Carcinoma	829	Patupilone	nmbgrgekxh(bqzmzfzncs) = yihudzmiqv bpaugknopg (coskjzvifb ) View more	Negative	01 Nov 2012
NCT00262990 (Pubmed \| J Clin Oncol)	Phase 3	Platinum-Resistant Primary Peritoneal Carcinoma	829	Pegylated liposomal doxorubicin (PLD)	nmbgrgekxh(bqzmzfzncs) = kafaxaefzq bpaugknopg (coskjzvifb ) View more	Negative	01 Nov 2012
ASCO2011	Phase 3	Ovarian Cancer	829	Patupilone	apgttlrkta(uqetlxgoeg) = bvkqkdkptk vmpegdhrgj (dzuaqfvuan )	-	20 May 2011
ASCO2011	Phase 3	Ovarian Cancer	829	Pegylated liposomal doxorubicin (PLD)	apgttlrkta(uqetlxgoeg) = auqrbduapj vmpegdhrgj (dzuaqfvuan )	-	20 May 2011
ASCO2011	Phase 1	Metastatic Colorectal Carcinoma	43	EPO906	zrjahfdvyu(lzshosktyv) = nlcxryjaux gzlxixwbwe (lbhlctmtvc ) View more	-	20 May 2011
ASCO2009	Phase 1	Central Nervous System Neoplasms	32	Patupilone	hzssyojmnf(bhkoozaacu) = cohdbrsfzi rygewadjwk (ebxfsjqllj )	-	20 May 2009
ASCO2009	Phase 2	Platinum-Resistant Primary Peritoneal Carcinoma	113	Patupilone 10 mg/m2	qoyvsdtelk(jvpmbcwjic) = wbfxitwpiz hqvoubaaim (petpihgxhq, 3.0% - 14.0%) View more	Positive	20 May 2009
ASCO2008	Phase 1	Solid tumor	18	patupilone (Normal hepatic function)	zerogwoepl(gkjasefwhv) = ihkleymqle ujfwiuysgi (hgixsxpffp ) View more	-	20 May 2008
ASCO2008	Phase 1	Solid tumor	18	patupilone (Mildly impaired hepatic function)	zerogwoepl(gkjasefwhv) = jaytxjcnhq ujfwiuysgi (hgixsxpffp ) View more	-	20 May 2008
ASCO2008	Phase 2	Non-Small Cell Lung Cancer	27	Patupilone	izyechbhpe(dquhleooaf) = cjsoearvfe vpkixcezdg (uqezywxnxl ) View more	-	20 May 2008

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