CytRx Begins Phase 2 Trial With Aldoxorubicin For AIDS-Related Kaposi's Sarcoma

(RTTNews) - CytRx Corp. (CYTR), a biopharmaceutical research and development company specializing in oncology, said it has begun a Phase 2 study to determine preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposi's sarcoma or KS.

In this open-label Phase 2 trial, 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 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 main objective of preliminary efficacy will be determined via. evaluation of the size, number and nodularity of skin lesions, and the company will assess the level of aldoxorubicin uptake into lesions. Safety will be evaluated through monitoring of adverse events and the ability to remain on assigned treatment.

CytRx intends to discuss a pathway for the registration of aldoxorubicin for KS with the FDA, provided the data are positive. The firm would announce data from this Phase 2 trial in the second quarter of 2015. Kaposi's sarcoma is an orphan indication.