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CytRx’s New Aldoxorubicin Data Demonstrates Significant Advantages Over Doxorubicin

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today 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 compared with doxorubicin 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.”

Increased Responses Show OVERALL RESPONSE RATE of 22% in Global Phase 2b Trial in Advanced Soft Tissue Sarcoma

Preliminary data from the Phase 2b clinical trial directly comparing aldoxorubicin with doxorubicin as a first-line treatment for patients with metastatic, locally advanced or unresectable soft tissue sarcomas showed that aldoxorubicin-treated patients demonstrated a significantly greater percentage of overall responses compared with those treated with doxorubicin, the current standard-of-care for advanced, metastatic soft tissue sarcoma. This was based on a blinded reading of tumor scans by an independent radiology review. In this trial, aldoxorubicin was safely delivered at 3.5 times the dose level of doxorubicin in the comparator arm. The overall response data, which were reviewed on a blinded basis by independent radiologists, are as follows:
82 Evaluated Patients

58 aldoxorubicin-treated

24 doxorubicin-treated
Number Percentage Number Percentage
Partial response 13 22% 0 0%
Stable disease 27 46% 11 46%

Responses were evaluated using the RECIST 1.1 criteria. Partial responses are defined as at least a 30% shrinkage in the sum of the longest diameters of target tumors with no increase in non-target tumors or development of new tumors. Stable disease is defined as less than a 20% increase in the longest diameter of target tumors with no increase in non-target tumors or development of new tumors.

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