This is a Phase 1/2, multicenter, open-label, dose-escalation study that will determine the MTD and RP2D of L-Annamycin in combination with cytarabine for the treatment of subjects with AML.

开始日期2022-09-29

申办/合作机构

Moleculin Biotech, Inc.

NCT04887298 / Completed临床1/2期

Phase 1B/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects with Previously Treated Soft-Tissue Sarcomas with Pulmonary Metastases

This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.

开始日期2021-06-05

申办/合作机构

Moleculin Biotech, Inc.

100 项与安纳霉素相关的临床结果

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100 项与安纳霉素相关的转化医学

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100 项与安纳霉素相关的专利（医药）

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项与安纳霉素相关的文献（医药）

2023-05-01·European journal of cancer (Oxford, England : 1990)

Anthracycline-induced cardiotoxicity — are we about to clear this hurdle?

Review

作者: Reuther, Susanne ; Dempke, Wolfram C. M. ; Winkler, Christina ; Priebe, Waldemar ; Silberman, Sandra ; Zielinski, Rafal

Anthracyclines have contributed significantly to remarkable improvements in overall survival and are regarded as the most effective cytostatic drug for cancer treatment in various malignancies. However, anthracyclines are a significant cause of acute and chronic cardiotoxicity in cancer patients, and long-term cardiotoxicity can lead to death in about one-third of patients. Several molecular pathways have been implicated in the development of anthracycline-induced cardiotoxicity, although the underlying mechanisms of some molecular pathways are not fully elucidated. It is now generally believed that anthracycline-induced reactive oxygen species (resulting from intracellular metabolism of anthracyclines) and drug-induced inhibition of topoisomerase II beta are the key mechanisms responsible for the cardiotoxicity. To prevent cardiotoxicity, several strategies are being followed: (i) angiotensin-converting enzyme inhibitors, sartans, beta-blockers, aldosterone antagonists, and statins; (ii) iron chelators; and (iii) by development of new anthracycline derivatives with little or no cardiotoxicity. This review will discuss clinically evaluated doxorubicin analogues that were developed as potentially non-cardiotoxic anticancer agents and include recent development of a novel liposomal anthracycline (L-Annamycin) for the treatment of soft-tissue sarcoma metastatic to the lung and acute myelogenous leukaemia.

2018-07-01·Forensic toxicology3区 · 医学

Use of hepatocytes isolated from a liver-humanized mouse for studies on the metabolism of drugs: application to the metabolism of fentanyl and acetylfentanyl

3区 · 医学

Article

作者: Kanamori, Tatsuyuki ; Segawa, Hiroki ; Yamamuro, Tadashi ; Inoue, Hiroyuki ; Kuwayama, Kenji ; Togawa-Iwata, Yuko ; Tsujikawa, Kenji

PURPOSE:

The usefulness of hepatocytes isolated from a liver-humanized mouse (PXB-cells) as a model in vitro system for the prediction of the in vivo metabolism of new drugs of abuse was evaluated.

METHODS:

For the drug metabolism study, fentanyl, a powerful synthetic opioid, and acetylfentanyl, an N-acetyl analog of fentanyl, were selected as model drugs. PXB-cells were cultured with the drug for 24-48 h and then the media were collected and analyzed by liquid chromatography/mass spectrometry after deproteinization with acetonitrile.

RESULTS:

The main metabolite formed from fentanyl by PXB-cells was the desphenethylated metabolite (nor-fentanyl), and the other major metabolites formed were 4'-hydroxy-fentanyl, β-hydroxy-fentanyl and (ω-1)-hydroxy-fentanyl. ω-Hydroxy-fentanyl and 4'-hydroxy-3'-methoxy-fentanyl were the minor metabolites. Similar results were obtained for acetylfentanyl. The metabolite profile of fentanyl in PXB-cells was consistent with the in vivo metabolite profile of fentanyl reported previously. Most of the 4'-hydroxy- and 4'-hydroxy-3'-methoxy-metabolites of fentanyl and acetylfentanyl were conjugated in PXB-cells, indicating that PXB-cells had high conjugation enzyme activities. From experiments using human liver microsomes and anti-CYP antibodies, it was revealed that CYP3A4 was involved in the production of nor-fentanyl, β-hydroxy-fentanyl and (ω-1)-hydroxy-fentanyl, while CYP2D6 was partially involved in the production of 4'-hydroxy-fentanyl.

CONCLUSIONS:

Our results indicated that PXB-cells have high activities of phase I and phase II drug-metabolizing-enzymes, can be stably supplied, and are easy to use; thus, PXB-cells are highly useful for the prediction of the in vivo metabolism of drugs of abuse.

2013-08-01·Clinical lymphoma, myeloma & leukemia4区 · 医学

Phase I/II Trial of Nanomolecular Liposomal Annamycin in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

4区 · 医学

Article

作者: Susan O'Brien ; Debora A. Thomas ; Robert Shepard ; Hagop M. Kantarjian ; Michael Andreeff ; Thompson L. Heffner ; Eunice S. Wang ; Samir Parekh ; Meir Wetzler ; Laurie A. Ford

BACKGROUND:

Treatment options for relapsed/refractory ALL in adult patients remain challenging. Annamycin is a highly lipophilic form of the anthracycline doxorubicin with the ability to bypass multidrug resistance mechanisms of cellular drug resistance.

PATIENTS AND METHODS:

We performed a phase I/II multicenter, open-label, study to determine the maximally tolerated dose (MTD) of nanomolecular liposomal annamycin in adult patients with refractory ALL.

RESULTS:

Thirty-one patients were enrolled; the MTD was determined to be 150 mg/m(2)/d for 3 days. Other than tumor lysis syndrome, there were 3 grade 3 mucositis which comprised the MTD determination. There was also 1 case each of grade 3 diarrhea, typhlitis, and nausea. After determining the MTD, a 10-patient phase IIA trial was conducted. Eight of the patients completed 1 cycle of the 3 days of treatment at the MTD. Of these, 5 (62%) had an efficacy signal with complete clearing of circulating peripheral blasts. Three of these subjects also cleared bone marrow blasts with 1 subsequently proceeding onto successful stem cell transplantation.

CONCLUSION:

Single-agent nanomolecular liposomal annamycin appears to be well tolerated, and shows evidence of clinical activity as a single agent in refractory adult ALL.

项与安纳霉素相关的新闻（医药）

2024-11-12

·PRNewswire

Moleculin Receives Institutional Review Board Approval for MIRACLE Phase 3 Pivotal Trial of Annamycin in Combination with Cytarabine for the Treatment of R/R Acute Myeloid Leukemia (AML)

Company on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Trial designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML HOUSTON, Nov. 12, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has received Institutional Review Board (IRB) approval for its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108). This Phase 3 "MIRACLE" trial (derived from Molecul in R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US. "IRB approval marks an important milestone towards the launch of our MIRACLE pivotal Phase 3 trial of Annamycin in AML patients. Our team is focused on getting clinical trial sites up and running, and we believe we will be in a position to commence enrollment in the first quarter of 2025," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "We have been extremely busy meeting with potential investigators for this study and are highly encouraged by these conversations. The positive feedback from the clinicians on the strength of our data generated to date, along with our alignment with FDA on the strategic design of the MIRACLE study, gives us a high level of confidence as we take these next steps toward potentially bringing a much needed solution to AML patients." The MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, is expected to initially utilize an adaptive design whereby the first 75 to 90 subjects will be randomized in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, such doses were specifically recommended by the FDA in our end of Phase 1B/2 meeting. At that point, the trial will be unblinded to select the optimum dose for Annamycin. For Part B of the trial, approximately 240 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin. The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA's new Project Optimus initiative. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA). About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is initiating the MIRACLE ( Molecul in R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit and connect on X, LinkedIn and Facebook. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the commencement of enrollment of the MIRACLE trial. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 [email protected] SOURCE Moleculin Biotech, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期孤儿药快速通道加速审批

2024-11-11

·PRNewswire

Moleculin Reports Third Quarter 2024 Financial Results and Provides Corporate Update

- On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 - Median durability of CRc in MB-106 Annamycin+ Cytarabine AML clinical trial continues to climb - now past 8 months - Recent virtual AML KOL event underscores how Annamycin could significantly change the AML treatment landscape; Replay available here - Company to host conference call and webcast today, Monday, November 11th at 8:30 AM ET HOUSTON, Nov. 11, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today reported its financial results for the quarter ended September 30, 2024. As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, November 11, 2024 (details below). "We are thrilled to have emerged as a late stage company. Our focus remains on the ramp up for and execution of our upcoming MIRACLE trial. We have been extremely active and our recent interactions with potential clinical trial sites globally have been overwhelmingly positive as we prepare for the start of enrollment and dosing early next year. We believe with our recent clinical and regulatory 'wins,' we have foundationally set the stage for a transformational year ahead and the opportunity to drive significant value for all stakeholders. With that said, we continue to follow our CRc (complete response composite) preliminary data from our MB-106 Phase 1B/2 AML clinical trial. We are also pleased with the median durability continuing to climb – and is now in excess of 8 months," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. Recent Highlights Appointed Daniel D. Von Hoff, M.D., F.A.C.P., FASCO, FAACR, leading expert in Pancreatic Cancer to its Scientific Advisory Board to Support Development of Annamycin; Hosted a Virtual Acute Myeloid Leukemia KOL event with internationally renowned Acute Myeloid Leukemia (AML) Key Opinion Leaders to discuss Annamycin, the use of anthracyclines, how Annamycin could significantly change the AML treatment landscape, and the Company's recently announced global Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (the "MIRACLE" trial); Presented positive in vivo efficacy data of Annamycin in orthotopic and experimental lung metastatic models of Sarcoma in a poster titled "Annamycin: Opening New Doors for Organotropic Targeting of Primary and Metastatic Lung Cancer," at the IASLC 2024 World Conference on Lung Cancer; Commenced enrollment and treatment of patients in the Investigator-initiated Phase 2 study evaluating WP1066 in combination with radiation therapy for the treatment of adults with glioblastoma; and Closed a $5.5 million financing upfront with up to an additional $11.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants. Clinical Development Update Annamycin is currently being evaluated in ongoing clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA). AML The Company recently announced the positive discussion and outcome of its End of Phase 1B/2 (EOP1B/2) meeting with the US Food and Drug Administration (FDA) supporting the advancement of Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Molecul in R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US. The MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, is expected to initially utilize an adaptive design whereby approximately the first 75 to 90 subjects will be randomized to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin. At that point, the trial will be unblinded to select the optimum dose for Annamycin. For the second part of the trial, approximately 240 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin. The selection of the optimum dose will be based not only on the overall balance of safety, tolerability, pharmacokinetics and efficacy, consistent with the FDA's new Project Optimus initiative. Expected Milestones for Annamycin AML Development Program 4Q 2024 – Contracting with MIRACLE trial sites and IRB approval 1Q 2025 – First subject treated in MIRACLE trial 4Q 2025 – Recruitment and overall efficacy rate update (n=45) 2H 2026 – Interim efficacy and safety data (n=90) unblinded and Optimum Dose set for MIRACLE trial 2027 – Begin enrollment of 3rd line subjects in MIRACLE2 2027 – Enrollment ends in 2nd line subjects 2028 – Primary efficacy data for 2nd line subjects in MIRACLE 2028 2H – Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE STS Lung Metastases As previously announced, the Company completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases. Subjects who had stable disease at the time of study discontinuation were followed for progression free response and overall survival. The study database is locked, and the clinical study report is being written and should be completed in early 2025 and will be released in detail at that time Expected Milestones for Annamycin STS Lung Mets Development Program 2025 – Final MB-107 data readout 2025 – Identify next phase of development / pivotal program Summary of Financial Results for the Third Quarter 2024 Research and development (R&D) expense was $4.9 million and $3.3 million for the three months ended September 30, 2024 and 2023, respectively. The increase over the prior year period is mainly related to costs incurred for clinical trials (clinical research organization and drug production) and sponsored research costs. General and administrative expense was $2.2 million and $2.6 million for the three months ended September 30, 2024 and 2023, respectively. The decrease of $0.4 million is mainly related to a decrease in regulatory and legal fees. As of September 30, 2024, the Company had cash and cash equivalents of $9.4 million and believes that the existing cash and cash equivalents as of September 30, 2024, will be sufficient to fund planned operations into the first quarter of 2025. Conference Call and Webcast Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties on Monday, November 11, 2024 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is initiating the MIRACLE ( Molecul in R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit and connect on X, LinkedIn and Facebook. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company's forecasted cash burn rate (including its estimate of cash sufficient to meet its projected operating requirements) and the achievement of the expected milestones set forth above. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 [email protected] SOURCE Moleculin Biotech, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期快速通道临床2期孤儿药财报

2024-11-05

·PRNewswire

Moleculin to Report Third Quarter 2024 Financial Results on November 8, 2024 and Host Conference Call and Webcast

HOUSTON, Nov. 5, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will report its financial results for the quarter ended September 30, 2024, on Friday, November 8, 2024. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, November 11, 2024. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is initiating the MIRACLE ( Molecul in R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit and connect on X, LinkedIn and Facebook. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 [email protected] SOURCE Moleculin Biotech, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期财报

100 项与安纳霉素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	安纳霉素	-	DB06420

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床3期	-	Moleculin Biotech, Inc.	-
肉瘤	临床2期	美国	Moleculin Biotech, Inc.	2021-06-05
软组织肉瘤	临床2期	美国	Moleculin Biotech, Inc.	2021-06-05
急性淋巴细胞白血病	临床2期	美国	Callisto Pharmaceuticals, Inc.	2005-10-01
乳腺癌	临床2期	美国	Aronex Pharmaceuticals, Inc.	-
乳腺癌	临床2期	-	Callisto SAS	-
乳腺癌	临床2期	-	The University of Texas MD Anderson Cancer Center	-
乳腺癌	临床2期	-	Moleculin Biotech, Inc.	-
费城染色体阳性慢性粒细胞白血病	临床2期	美国	Aronex Pharmaceuticals, Inc.	-
费城染色体阳性慢性粒细胞白血病	临床2期	-	The University of Texas MD Anderson Cancer Center	-

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05319587 (MB-106, EHA2024) 人工标引	临床1/2期	急性髓性白血病 Gene \| Chemical Biomarkers	17	L-ANNocytarabinecin (L-ANN) 190 mg/m²	(齋鹹選網糧壓鹹壓糧顧) = 衊簾簾鏇觸夢鬱鏇膚鬱蓋鬱鑰壓鑰餘構憲窪膚 (鏇鏇積觸網構簾廠衊衊 )	积极	2024-05-14
EUCTR2020-005493-10-PL \| NCT05319587 (PRNewswire) 人工标引	临床1/2期	急性髓性白血病一线	-	Annamycin+Cytarabine	鹽糧繭鬱齋醖獵網獵製(築網廠襯蓋醖壓築淵膚) = 鏇遞構繭構憲鏇淵積衊願糧觸憲艱齋衊鬱淵醖 (淵廠膚憲廠淵蓋積積鏇 ) 更多	积极	2024-01-24
				Annamycin+Cytarabine (dosed with Annamycin)	鹽糧繭鬱齋醖獵網獵製(築網廠襯蓋醖壓築淵膚) = 廠襯構膚壓壓製淵遞觸願糧觸憲艱齋衊鬱淵醖 (淵廠膚憲廠淵蓋積積鏇 ) 更多
NCT04887298 (MB-107, PRNewswire) 人工标引	临床1/2期	软组织肉瘤	-	Liposomal Annamycin	繭壓繭鬱襯鹽築構積鹹(遞築鑰積蓋淵糧遞鬱鹹) = 積選範淵構構獵淵鹹窪觸範餘築積鬱網顧糧醖 (鏇鹹餘夢範齋繭衊艱網 ) 更多	积极	2024-01-24
				Liposomal Annamycin (Phase 1B subjects with less than or equal to 2 prior treatments)	繭壓繭鬱襯鹽築構積鹹(遞築鑰積蓋淵糧遞鬱鹹) = 範鬱繭築醖觸醖淵網醖觸範餘築積鬱網顧糧醖 (鏇鹹餘夢範齋繭衊艱網 )
EUCTR2020-005493-10-IT \| NCT05319587 (MB-106 AML, Biospace) 人工标引	临床2期	急性髓性白血病	8	Annamycin 240 mg/m2 (Study MB-105)	膚遞夢網膚築觸膚襯遞(鏇膚壓淵顧鹹遞製憲製) = 範築簾範築繭積鑰鹽簾積醖簾膚製網顧憲鹽鑰 (襯夢糧襯淵鑰鏇鑰餘簾 ) 更多	积极	2023-11-13
				Ara-C + Annamycin (Study MB-106 Combination Therapy – Phase 1B)	膚遞夢網膚築觸膚襯遞(鏇膚壓淵顧鹹遞製憲製) = 醖鏇蓋衊構觸築淵繭範積醖簾膚製網顧憲鹽鑰 (襯夢糧襯淵鑰鏇鑰餘簾 ) 更多
MB-107 STS (Biospace) 人工标引	临床2期	软组织肉瘤	32	Annamycin	積壓廠糧淵膚繭觸壓觸(願鏇顧遞願選夢鹽壓積) = 觸簾壓廠獵築願憲鑰獵艱積鹹淵壓鏇鹹衊築鹽 (壓鬱簾製範積簾遞構艱 ) 更多	积极	2023-11-13
				Annamycin (Phase 1B)	積壓廠糧淵膚繭觸壓觸(願鏇顧遞願選夢鹽壓積) = 鹹遞構網觸窪遞範鏇窪艱積鹹淵壓鏇鹹衊築鹽 (壓鬱簾製範積簾遞構艱 ) 更多
NCT04887298 (MB107, Biospace) 人工标引	临床1/2期	肉瘤	33	Annamycin	製鑰鏇繭憲壓製簾鹹鹹(鬱顧膚鏇顧構選艱夢艱) = 廠憲製觸製艱鑰鏇膚築襯壓鬱獵簾製顧觸鹽艱 (選鏇齋範遞構醖築簾築 )	积极	2023-11-06
				Annamycin 330 mg/m2	範積夢鹽遞遞遞選衊壓(壓願壓齋衊窪鹽鑰襯憲) = 蓋壓築糧壓襯製壓鏇壓夢膚選範獵鏇齋鹹網顧 (獵積鏇蓋襯網顧醖獵鹽 )
NCT04887298 (PRNewswire) 人工标引	临床1/2期	继发性肺恶性肿瘤	-	Annamycin	選願憲鏇醖蓋壓願築廠(選網鬱餘膚餘顧膚夢夢) = demonstrate no evidence of cardiotoxicity to date 廠夢構淵鏇窪窪醖範積 (觸鹹選膚齋淵築鏇構獵 )	积极	2023-09-18
NCT04887298 (AACR2022)	临床1/2期	结肠转移性腺癌	-	L-Annamycin	醖網範顧廠簾膚艱憲膚(選觸憲鹹簾構獵簾築醖) = 積顧襯範構醖觸網艱衊觸鑰鏇構網壓夢壓淵糧 (選積製齋鑰願網醖觸襯 )	-	2022-06-15
				Vehicle	醖網範顧廠簾膚艱憲膚(選觸憲鹹簾構獵簾築醖) = 製艱鑰艱餘積鏇築醖鏇觸鑰鏇構網壓夢壓淵糧 (選積製齋鑰願網醖觸襯 )
ASCO2009	临床1期	难治性急性淋巴细胞白血病二线	-	nanomolecular liposomal annamycin	簾夢齋夢夢鬱構淵鹹餘(鑰網衊願鹽顧選鬱築淵) = 蓋觸夢糧願衊餘網範顧艱壓觸觸蓋襯餘範築夢 (鹹顧顧鹽衊築憲襯繭齋 ) 更多	-	2009-05-20