CytRx: Aldoxorubicin Data Demonstrates Significant Advantages Over Doxorubicin
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9/30/2013 6:11 AM ET
CytRx Corp. (CYTR: Quote) announced compelling preliminary data from its global Phase 2b soft tissue sarcoma trial indicating that patients treated with aldoxorubicin had a significantly higher OVERALL RESPONSE RATE or ORR of 22% as compared to those administered the widely used chemotherapeutic agent doxorubicin with an ORR of 0%.
"Although preliminary, we are certainly optimistic about aldoxorubicin's prospects in soft tissue sarcoma based on the favorable results from our earlier second-line Phase 1b/2 clinical trial in patients who had failed other therapies and these preliminary overall response results as a first-line treatment announced today ," said Executive Vice President and Chief Medical Officer Daniel Levitt.
CytRx announced additional data from a trial in immunodeficient mice transplanted with human glioblastoma cells in their brain that showed those animals treated with aldoxorubicin had a median survival rate of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline.
The company said it plans to initiate a Phase 2 clinical trial in 2013 evaluating the preliminary efficacy of aldoxorubicin in patients with AIDS-related Kaposi's sarcoma, a common HIV-associated tumor. The current standard-of-care for severe dermatological and systemic Kaposi's sarcoma is liposomal doxorubicin (Doxil); however, a significant proportion of patients exhibit minimal to no clinical response to this agent and the drug's toxicity often prevents continued therapy. The Phase 2 trial will enroll up to 30 patients and will be conducted at the LSU Health Science Center in New Orleans.