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.
"Aldoxorubicin has demonstrated effectiveness against a range of tumors in both human and animal studies, thus we are optimistic in regard to a potential treatment for Kaposi's sarcoma. The current standard-of-care for severe dermatological and systemic KS is liposomal doxorubicin (Doxil®). However, many patients exhibit minimal to no clinical response to this agent, and that drug has significant toxicity and manufacturing issues," said CytRx President and CEO Steven A. Kriegsman. "In addition to obtaining valuable information related to Kaposi's sarcoma, this trial represents another opportunity to validate the value and viability of our linker technology platform."
CytRx plans to discuss a pathway for the registration of aldoxorubicin for KS with the FDA if the data are positive. The Company expects to announce data from this Phase 2 clinical trial in the second quarter of 2015.
Kaposi's sarcoma is an orphan indication. In the United States, under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease that affects fewer than 200,000 individuals in the country. The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA requirements. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee.