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HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), currently trading at $0.39 and down over 80% in the past year according to InvestingPro data, is expanding its Phase 2B/3 clinical trial for acute myeloid leukemia (AML) treatment across multiple countries in September, according to a company press release.
The trial, known as MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation), is testing Annamycin in combination with cytarabine for patients with relapsed or refractory AML. The company, with a market capitalization of $14.3 million and maintaining more cash than debt on its balance sheet according to InvestingPro analysis, reported that 13 subjects have been recruited so far, with 10 already receiving treatment.
Moleculin plans to add eight new active sites by the end of September, bringing the total to 20 sites recruiting patients across Ukraine, Spain, Georgia, Poland, Romania, Italy, Lithuania, and the United States. The company expects to have recruited 20 subjects by month-end.
The trial follows an adaptive design where the first 75 to 90 subjects will be randomized into three groups in Part A, receiving either placebo with high-dose cytarabine or one of two Annamycin dosages (190 mg/m² or 230 mg/m²) with cytarabine.
The protocol allows for preliminary data unblinding after 45 subjects, which Moleculin anticipates reaching in Q4 2025. A second data unblinding is expected in the first half of 2026 at the conclusion of Part A.
"We are confident in our target to recruit the 45th subject by Q4 2025 and achieve our first data unblinding shortly thereafter," said Walter Klemp, Chairman and CEO of Moleculin, in the press release.
Annamycin, also known as naxtarubicin, has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, as well as Orphan Drug Designation for soft tissue sarcoma treatment. With analyst price targets ranging from $4 to $12, significantly above current levels, investors seeking deeper insights can access comprehensive analysis and 12 additional ProTips through InvestingPro’s detailed research reports.
In other recent news, Moleculin Biotech, Inc. has made significant progress in its clinical trials and strategic initiatives. The company has successfully enrolled its first two patients in the European Union for its pivotal Phase 2B/3 trial of Annamycin combined with cytarabine for treating relapsed or refractory acute myeloid leukemia (AML). Additionally, Moleculin received approval from Georgia’s Regulation Agency for Medical and Pharmaceutical Activities for the same trial, further extending its global reach. In a notable development, Moleculin was granted a Notice of Intent to Grant for a European patent application covering its cancer drug candidate Annamycin, which could extend patent protection until 2040.
Furthermore, Moleculin has entered into a $6.5 million At The Market Offering Agreement with Roth Capital Partners, LLC, allowing the company to sell shares from time to time. The company also appointed Adriano Treve, a former Roche executive, as a Strategic Advisor to enhance its partnerships. These recent developments indicate Moleculin’s ongoing efforts to strengthen its position in the pharmaceutical industry.
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