CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a Phase 2 clinical trial to determine preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposi's sarcoma (KS).
In this open-label Phase 2 clinical trial conducted at the Louisiana State University Health Sciences Center in New Orleans, up to 30 patients in three equal arms will be administered aldoxorubicin at 50, 100 or 150 mg/m2 by 30-minute intravenous infusion. Because the KS patients in the study have compromised immune systems, aldoxorubicin dosages administered to patients in the trial will be lower than those administered in CytRx's clinical testing of aldoxorubicin in patients with soft tissue sarcomas. Patients will receive aldoxorubicin on day 1, then every 3 weeks until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. The primary objective of preliminary efficacy will be determined through evaluation of the size, number and nodularity of skin lesions, and the Company will evaluate the level of aldoxorubicin uptake into lesions. Safety will be assessed through monitoring of adverse events and the ability to remain on assigned treatment.