In a recent press release, pharmaceutical company Moleculin Biotech, Inc. (“Moleculin”) shared a recent advance in the sphere of medical and health research. Agencja Badań Medycznych, a Polish agency which contributes to medical and health science research, extended a $1.5M grant to the Maria Sklodowska-Curie National Research Institute. The grant will facilitate a Phase 1b/2 clinical trial evaluating Moleculin’s therapeutic candidate Annamycin for patients with soft tissue sarcoma (STS) which has metastasized to the lungs.

Annamycin

Professor Piotr Rutkowski, MD, PhD will head the clinical trial with the assistance of WPD Pharmaceuticals. If all goes well, the clinical trial will begin at some point in 2021. Moleculin’s only participation will be providing the Annamycin. But what is Annamycin? Moleculin describes the drug as:

a unique next-generation liposome formulated anthracycline (also referred to in literature as “L-Annamycin”) that has been designed to eliminate cardiotoxicity and avoid the multidrug resistance mechanisms that often defeat currently approved anthracyclines. In animal models designed to test for cardiotoxicity, Annamycin was shown to be non-cardiotoxic and in human clinical trials focused on leukemia, it showed fewer dose-limiting toxicities than are normally experienced with doxorubicin (one of the leading first-line anthracyclines used for induction therapy).

Beyond soft tissue sarcoma, Moleculin has been exploring Annamycin as a treatment for acute myeloid leukemia (AML). In patients with STS, many treatment options do not exist once the cancer has metastasized. Those whose cancer metastasized to the lungs often face Adriamycin (doxorubicin) therapy, as surgery is more difficult at this point. However, only 30% of patients or less respond well to doxorubicin, causing additional health issues down the line. Additionally, too much doxorubicin can be toxic. Thus, if Annamycin is found to be effective, it offers a new treatment avenue for patients.

Soft Tissue Sarcoma (STS)

Doctors are not exactly sure what causes soft tissue sarcoma (STS), a rare cancer which occurs in the body’s soft tissues. Typically, soft tissue provides connectivity and support to other bodily structures. This means STS can appear in fat, blood vessels, nerves, or even the lining of your joints. Other conditions, or radiation exposure, may increase the risk of developing soft tissue sarcoma. There are multiple subtypes of STS, including rhabdomyosarcoma, synovial sarcoma, and epithelioid sarcoma.

In early stages of the cancer, patients with STS may experience no symptoms. However, symptoms may appear as the tumor grows. These include:

• Pain (if the tumor is pressing against nerves, muscles, or joints)
• A noticeable lump or swelling, especially one that is becoming larger over time
• Cramping and abdominal pain (if the tumor is abdominally located)
• Breathlessness or coughing (if the tumor is located near the lungs)