Phase 2 Trial Evaluates Annamycin Plus Ara-C In AML

The evaluation of Annamycin in combination with Ara-C (cytarabine) has launched in a new Phase 1B/2 trial, called MB-106, for patients with acute myeloid leukemia (AML). The trial was put in place by Moleculin Biotech, a pharmaceutical company evaluating these drugs.

Annamycin is designed to safely treat patients with AML, in comparison with other medications that negatively affect the heart. When tested on animals, results showed that doxorubicin, a common medicine, reaches the lungs less than Annamycin. Using Annamycin has the ability to treat both AML and lung cancer, specifically soft tissue sarcoma, according to a recent press release.

Ara-C is a chemotherapy medication that focuses on treating leukemia and other blood disorders, according to the National Institutes of Health. It works by dividing cancer cells and interfering with a patient’s DNA replication process. It focuses on halting cancer cells from reproducing. It is frequently in use with other drugs to efficiently treat patients with specific cancers.

"This milestone marks an important step in advancing the development of Annamycin for the treatment of AML. Based on the positive preliminary results demonstrated in the Phase 1B portion of this trial, we continue to believe that Annamycin has the potential to be a meaningful treatment option for the treatment of AML,” explained Walter Klemp, chairman and chief officer of Moluclin Biotech, in a recent news release.

According to the news release, the trial is focusing on the safety and efficiency of the treatment based on data found from two finished phase 1 trials, MB-104 and MB-105, which were conducted in the U.S. and Europe, respectively. These two trials identified the use of Annamycin in patients with AML.

Patients within the study averaged at about 66 years old. The study was completed when combining 230 mg/m2 of Annamycin with Cytarabine. The total complete response within this study averaged out to about 33% in the patients enrolled. The phase 2 section of this trial will begin from the 230 mg/m2 dosage of Annamycin.

Annamycin is now in place with current Fast Track Status and Orphan Drug Designation from the Food and Drug Administration (FDA). The drug is focusing on treating STS lung metastases and relapsed or refractory acute myeloid leukemia.

“Our team is dedicated to building on the momentum and encouraging results to bring this study across the finish line and towards late-stage development,” Klemp noted in the press release.

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