Today before the opening bell, CytRx 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 (ORR) of 22% as compared to those administered the widely used chemotherapeutic agent doxorubicin with an ORR of 0%.
Additionally, Aldoxorubicin produced statistically significant improvement in survival rates in animals with a human model of glioblastoma (brain tumor), and showed an improved and narrow distribution of aldoxorubicin within the human body in a pharmacokinetics trial. Results from the glioblastoma trial and pharmacokinetics trial were discussed in poster presentations at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO) being held in Amsterdam, Netherlands.
“We are compiling an ever-increasing portfolio of impressive human and pre-clinical data that aldoxorubicin could have an essential role in the treatment of patients with a wide range of cancers,” said CytRx President and CEO Steven A. Kriegsman. “This collective body of data gives us tremendous hope that we will be able to make an important difference in the lives of cancer patients worldwide. This data also supports our belief in the potential benefit of our linker technology platform to one day form the basis of a multi-billion dollar revenue oncology franchise with drugs to treat a wide range of cancers.
“Given the promising prospects for aldoxorubicin, we are aggressively moving forward with its clinical development,” he added. “We recently received acceptance from the U.S. Food and Drug Administration (FDA) for a protocol to conduct a Phase 2 clinical trial with aldoxorubicin in glioblastoma, a very difficult-to-treat and deadly cancer, and also plan to conduct a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma.”
Executive Vice President and Chief Medical Officer Daniel Levitt, M.D., Ph.D., added. “The magnitude of the clinical response difference supports our belief that aldoxorubicin could fill an important medical need in patients with advanced soft tissue sarcoma. 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. The study is ongoing and many of the patients with tumor responses and stable disease are still receiving treatment.” The Company expects to report top-line data for the global Phase 2b clinical trial in December 2013.
To read the entire press release, visit http://dtg.fm/AQ9m
For more information on CytRx, visit http://cytrx.com
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