On February 1, 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 that it has signed an agreement with Catalyst Clinical Research (Catalyst), a contract research organization, to manage its US clinical trial to study the ability of Annamycin to treat soft tissue sarcoma (STS) that has metastasized to the lungs (Press release, Moleculin, FEB 1, 2021, View Source [SID1234574461]).
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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)
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 as 20% to 50% of STS will eventually metastasize to the lungs, where treatment can become more challenging.
Once metastasized to the lungs, if tumors cannot be surgically removed, the primary chemotherapy regimen is the anthracycline doxorubicin, also known as Adriamycin. While 10% to 30% of patients with sarcoma lung metastases may initially respond to doxorubicin, most will relapse, leaving the majority of these patients without an alternative chemotherapy. Treatment options are further limited because of the inherent cardiotoxicity of currently approved anthracyclines, including doxorubicin, which limits the amount of anthracycline that can be given to patients.
Annamycin is a "next generation" anthracycline that has recently been shown in animal models to accumulate in the lungs at up to 34 times the level of doxorubicin. Importantly, Annamycin has also demonstrated a complete lack of cardiotoxicity in recently conducted human clinical trials for the treatment of acute myeloid leukemia, so the use of Annamycin should not face the same dose limitations imposed on doxorubicin.
"As soon as we received IND (Investigational New Drug) status, we began reaching out to potential clinical sites, and the response has been very positive," commented Walter Klemp, Chairman and CEO of Moleculin. "We believe engaging a well-respected CRO such as Catalyst will enable us to move quickly to initiate sites and get this trial under way."
"It’s clear there is a significant unmet need for an improved therapy for STS lung metastases," added Catalyst CEO Nick Dyer. "Catalyst Oncology is thrilled to be the selected partner to collaborate with Moleculin on this potentially ground-breaking study."