On May 25, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported it has received clearance to initiate its Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases (Press release, Moleculin, MAY 25, 2021, View Source [SID1234580551]). The first of several planned clinical sites is now open and the Company expects to begin patient enrollment.
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Soft tissue sarcomas are the most common form of sarcoma, accounting for an estimated 130,000 incident cases per year worldwide. While many sarcomas can be addressed through surgical removal, it is estimated that as many 20% to 50% of STS sarcomas will eventually metastasize to the lungs, where treatment can become more challenging. Recently published animal data suggests that the efficacy of the current standard of care chemotherapy (doxorubicin) may be limited due to its inability to accumulate sufficiently in the lungs. The use of doxorubicin and other currently approved anthracyclines for STS lung metastases is further limited due to their inherent cardiotoxicity, which limits the amount of anthracycline that can be given to patients.
Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of acute myeloid leukemia (AML), and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases.
"We remain dedicated to advancing this program forward and are pleased to have received clearance to begin patient enrollment. With the data seen to-date, we believe Annamycin has the potential to be the first non-cardiotoxic anthracycline and address the limitations with current treatment options. Our clinical teams are diligently working to complete additional site initiations and get patient enrollment and dosing underway as efficiently and expeditiously as possible," commented Walter Klemp, Chairman and CEO of Moleculin.
The Phase 1b/2 study is a a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum- tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) and safety of Annamycin and in Phase 2 will explore the efficacy of Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate. A minimum of 3 subjects for each dosing cohort will be enrolled in the Phase 1b portion of the study until an MTD is identified. A maximum of 25 subjects will be enrolled at the RP2D to further evaluate efficacy.
Based on a recently announced reimbursement grant awarded in Poland, the Company also expects a second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases to be initiated in 2021, which will be primarily investigator-funded in Europe.
Annamycin has been granted Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of STS lung metastases.