Moleculin Reports Higher AML Complete Remission Rates And Durability With Additional Interim Subject Data
- Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13)
- Full MB-106 trial reaches 20 subjects with CRc of 45% in 1st – 7th line, with median durability at 4.9 months and climbing
- Interim data supports advancement to development of Phase 2 registration-directed clinical trial (MB-108) to further provide data for efficacy to support an eventual application for New Drug Approval (NDA)
- Virtual AML Clinical Day featuring internationally renowned clinician, Martin S. Tallman, MD, today, May 7th at 11:00 AM ET - Register Here
HOUSTON, May 7, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the presentation of positive interim data for Annamycin from its ongoing acute myeloid leukemia (AML) clinical development program. As previously announced, the Company will host a virtual AML Clinical Day, today, May 7, 2024, at 11:00 AM ET (details below) to discuss these results.
"Adding the latest two subjects in MB-106 AML trial with AnnAraC brings the composite complete remission (CRc) rate up from 37% to 45% for all of the 20 subjects with prior therapies ranging from none to six. This adds to our growing body of positive data which continues to provide a clear line of sight for our clinical and regulatory strategies towards registration for Annamycin in AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Focusing on 2nd line subjects, a CRc rate of 60% and with 50% of those being full CRs, AnnAraC has the potential to offer 2nd line patients a viable alternative, regardless of prior treatments or mutations. While we believe that the full trial results are impressive, we continue to believe that our results in 2nd line subjects, where there is a significant unmet need, are exceptional and believe the CRc rate demonstrated by AnnAraC in 2nd line patients substantially exceeds the performance reported by any drug currently approved for use in 2nd line AML."
"We continue to progress our preparations for an End of Phase 2 meeting with FDA and believe following this meeting we will be in a position to commence a pivotal registration study as a 2nd line therapy in AML early next year," added Mr. Klemp.