Moleculin Biotech, Inc, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, announced the first subject has been treated in Italy in the Company’s Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106).
“We continue to be highly encouraged by the data demonstrated from the successfully concluded Annamycin single agent trials and the no evidence of cardiotoxicity seen to date. We remain very optimistic in Annamycin’s potential to be an important treatment for refractory or relapsed AML in combination with Cytarabine. We are pleased to commence subject dosing in Italy and are continuing our efforts to bring additional sites online and build momentum in enrollment. We are committed to driving the development of Annamycin for the treatment of AML and look forward to continuing our evaluations of Annamycin in combination with Ara-C,” commented Walter Klemp, Chairman and CEO of Moleculin.
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Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines.
The Phase 1/2 MB-106 trial is an open label trial that builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, conducted in the U.S. and Europe, respectively. Highlights from the final data demonstrated in the MB-105 study include:
- MB-105 demonstrated 80% overall response rate (ORR) in final cohort for treatment of relapsed/refractory acute myeloid leukemia (R/R AML).
- Final reported results showed one CRi and three PRs (Partial Response).
- The responses in the MB-105 trial were seen in subjects 62-73 years of age and the CRi was from a subject 65 years of age.
SOURCE: PR Newswire