Moleculin Participates in Virtual Investor "What This Means" Segment
Moleculin Biotech (NASDAQ: MBRX) announced CEO Walter Klemp's participation in a Virtual Investor 'What This Means' segment, focusing on updates regarding the company's Phase 3 MIRACLE trial. The pivotal trial evaluates Annamycin in combination with Cytarabine (AnnAraC) for treating acute myeloid leukemia (AML) patients who are refractory to or relapsed after induction therapy.
The global MIRACLE trial (Moleculin R/R AML AnnAraC Clinical Evaluation) will include sites across the US, Europe, and the Middle East. During the segment, Klemp discussed recent developments in the AML space and their implications for Moleculin's Annamycin development program.
Moleculin Biotech (NASDAQ: MBRX) ha annunciato la partecipazione del CEO Walter Klemp a un segmento virtuale per investitori intitolato 'Cosa significa questo', concentrandosi sugli aggiornamenti riguardanti il trial di Fase 3 MIRACLE dell'azienda. Lo studio cruciale valuta l'Annamycin in combinazione con il Citarabina (AnnAraC) per il trattamento dei pazienti con leucemia mieloide acuta (LMA) che sono refrattari o recidivati dopo la terapia di induzione.
Il trial globale MIRACLE (Valutazione Clinica dell'AnnAraC di Moleculin R/R LMA) includerà siti negli Stati Uniti, in Europa e in Medio Oriente. Durante il segmento, Klemp ha discusso i recenti sviluppi nel campo della LMA e le loro implicazioni per il programma di sviluppo dell'Annamycin di Moleculin.
Moleculin Biotech (NASDAQ: MBRX) anunció la participación del CEO Walter Klemp en un segmento virtual para inversores titulado 'Lo que esto significa', enfocándose en las actualizaciones sobre el ensayo Fase 3 MIRACLE de la compañía. El ensayo clave evalúa el Annamycin en combinación con citarabina (AnnAraC) para tratar a pacientes con leucemia mieloide aguda (LMA) que son refractarios o que han recaído después de la terapia de inducción.
El ensayo global MIRACLE (Evaluación Clínica AnnAraC de Moleculin R/R LMA) incluirá sitios en EE.UU., Europa y Medio Oriente. Durante el segmento, Klemp discutió los desarrollos recientes en el campo de la LMA y sus implicaciones para el programa de desarrollo del Annamycin de Moleculin.
몰레쿨린 바이오텍 (NASDAQ: MBRX)는 CEO 월터 클렘프가 '이 의미하는 바'라는 가상 투자자 세그먼트에 참여한다고 발표하며, 회사의 3상 MIRACLE 임상 시험에 대한 업데이트에 중점을 두었습니다. 이 중요한 시험은 유도 치료 후 내성 또는 재발한 급성 골수성 백혈병(AML) 환자를 치료하기 위해 아나마이신과 시타라빈(AnnAraC)을 조합하여 평가합니다.
전 세계 MIRACLE 시험(몰레쿨린 R/R AML AnnAraC 임상 평가)은 미국, 유럽 및 중동의 사이트를 포함할 것입니다. 세그먼트 동안 클렘프는 AML 분야의 최근 개발 사항과 몰레쿨린의 아나마이신 개발 프로그램에 대한 그 의미를 논의했습니다.
Moleculin Biotech (NASDAQ: MBRX) a annoncé la participation de son PDG Walter Klemp à un segment virtuel pour investisseurs intitulé 'Ce que cela signifie', axé sur les mises à jour concernant l'essai de Phase 3 MIRACLE de la société. Cet essai phare évalue l'Annamycin en combinaison avec la Cytarabine (AnnAraC) pour traiter les patients atteints de leucémie myéloïde aiguë (LMA) qui sont refractaires ou qui ont rechuté après la thérapie d'induction.
L'essai mondial MIRACLE (Évaluation Clinique AnnAraC de Moleculin R/R LMA) comprendra des sites aux États-Unis, en Europe et au Moyen-Orient. Au cours du segment, Klemp a discuté des développements récents dans le domaine de la LMA et de leurs implications pour le programme de développement de l'Annamycin de Moleculin.
Moleculin Biotech (NASDAQ: MBRX) gab die Teilnahme von CEO Walter Klemp an einem virtuellen Investoren-Segment mit dem Titel 'Was das bedeutet' bekannt, das sich auf Updates zur Phase 3 MIRACLE-Studie des Unternehmens konzentriert. Die entscheidende Studie bewertet Annamycin in Kombination mit Cytarabin (AnnAraC) zur Behandlung von Patienten mit akuter myeloischer Leukämie (AML), die refraktär oder nach der Induktionsbehandlung rezidiviert sind.
Die globale MIRACLE-Studie (Moleculin R/R AML AnnAraC Klinische Bewertung) wird Standorte in den USA, Europa und dem Nahen Osten umfassen. Während des Segments sprach Klemp über die jüngsten Entwicklungen im AML-Bereich und deren Auswirkungen auf das Entwicklungsprogramm von Annamycin bei Moleculin.
- Advancement to Phase 3 trial stage indicates significant clinical progress
- Global trial expansion across multiple regions (US, Europe, Middle East) suggests broad market potential
- None.
– Walter Klemp, CEO of Moleculin, provides an update on the Company's Phase 3 pivotal trial of Annamycin for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (the "MIRACLE" trial)
– Watch the "What This Means" segment here
As part of the segment, Mr. Klemp discusses recent progress of the Company's Phase 3 pivotal trial 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 R/R AML. This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be global, including sites in the US,
The Virtual Investor "What This Means" segment featuring Moleculin is now available here.
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 (Moleculin 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 www.moleculin.com 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 achievements of each of the milestones in this press release. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company's ability to secure such financing on a timely basis. 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
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.
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