Aldoxorubicin is an investigational drug developed by the biopharmaceutical company CytRx for the treatment of small cell lung cancer (SCLC). SCLC is a deadly form of cancer that forms in the lung tissue and can spread to other parts of the body. It is most commonly associated with tobacco smoking.
How aldoxorubicin works
Aldoxorubicin is a modified version of a chemotherapeutic agent known as doxorubicin (Adriamycin). It is a rationally-engineered cytotoxic (meaning it’s toxic for the cell) drug that works by delivering doxorubicin into the tumor. It utilizes an acid-sensitive linker which chemically binds to albumin — the most abundant protein in the bloodstream.
Albumin facilitates the delivery of the chemically attached drug to the tumor sites. This delivery mechanism allows more selective delivery of cytotoxic doxorubicin to cancerous tissues and spares the surrounding healthy tissues and organs. Once at the tumor site, doxorubicin gets released from albumin due to the cleavage of the acid-sensitive linker, as the tumor environment has a lower pH. This mechanism also makes it possible to deliver doxorubicin to the tumor multiple times, thereby overcoming the key limitation of cumulative dose restrictions of doxorubicin.
Aldoxorubicin in clinical trials
Aldoxorubicin is currently being evaluated for effectiveness and safety in a Phase 2b multicenter clinical trial (NCT02200757). The trial compares the drug with topotecan, another chemotherapy drug in people with metastatic SCLC whose cancer returned or was resistant to prior chemotherapy.
In a company press release in September 2016, CytRx announced the completion of patient enrollment for this trial. A total of 132 patients from 41 sites across the U.S., Hungary, and Spain were enrolled. The trial uses a lower dose of aldoxorobuicin, aiming to improve the tolerability of the drug so that patients stay on the treatment longer.
Apart from SCLC, aldoxorubicin has been tested in approximately 600 patients with cancer and is currently being investigated in several clinical trials across multiple cancer types such as small tissue sarcoma.
CytRx announced last September that it plans to meet the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the submission of a new drug application for aldoxorobuicin, a process that may lead to the approval of aldoxorubicin as a drug for the treatment of patients with SCLC if the results of the Phase 2b clinical trial are positive.
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