Business
Moleculin Doses First Patient in Pivotal, Adaptive Phase 3 MIRACLE Trial
– Initial data readout on track for second half of 2025 HOUSTON, April 01, 2025 (GLOBE NEWSWIRE) -- 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 cancers and viruses, today announced the first patient has been dosed in its 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
About this update from Moleculin Biotech, Inc.
[{"type":"image","alt":"Moleculin Biotech, Inc.","displaySize":"","headline":null,"caption":"Moleculin Biotech, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":113,"url":"https://media.zenfs.com/en/globenewswire.com/6b5ac38e783ff6d5136647894faf0cc3"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/d2AUX0ok9awfDBaq.X9ICQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1ODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/6b5ac38e783ff6d5136647894faf0cc3","width":300,"height":113}},"lazy":false},{"type":"text","content":"– Initial data readout on track for second half of 2025","length":55,"tagName":"p"},{"type":"text","content":"HOUSTON, April 01, 2025 (GLOBE NEWSWIRE) -- 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 cancers and viruses, today announced the first patient has been dosed in its 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 refractory to or relapsed after induction therapy (R/R AML). This Phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, Europe and the Middle East.","length":749,"tagName":"p"},{"type":"text","content":"“The start of patient dosing represents a huge milestone for Moleculin and importantly, the AML community,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Our team remains focused on bringing clinical sites online in the U.S., Europe and Middle East and enrolling patients to build on this momentum. With the progress made to date, we expect to unblind preliminary data from the first 45 subjects in the second half of this year, a near-term, potentially value-driving milestone that will provide key insight as we continue to advance Annamycin’s development towards approval.”","length":606,"tagName":"p"},{"type":"text","content":"The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the 2B portion will be combined with the Phase 3 portion for purposes of measuring its primary endpoint. MIRACLE is subject to appropriate future filings with and potential additional feed...