Atlanta 11/2/2013 3:00:00 AM
News / Stocks

CytRX Corp. (CYTR) Reports Further Developments in Global Phase 2b Trial

MissionIR would like to highlight CytRx Corp. (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology. The company’s pipeline is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. The company also has rights to two additional drug candidates, tamibarotene and bafetinib.

In the company’s news,

CytRX Corp. released further clinical data from a multi-site global Phase 2b study comparing its aldoxorubicin as a first-line treatment for advanced soft tissue sarcomas (STS) versus the widely used chemotherapeutic agent doxorubicin. The data was presented at the 18th Annual Connective Tissue Oncology Society Meeting at the Sheraton New York Times Square Hotel in New York City, NY, including additional information that was collected and recorded September 27 to October 16, 2013.

Still ongoing, the study had 47 remaining active patients in the clinical trial as of October 16, 2013 (36 on aldoxorubicin and 11 on doxorubicin). CYTR expects it will report top-line progression-free survival results for the trial sometime in December 2013.

“We are very pleased with the continued clinical findings from our global Phase 2b trial with aldoxorubicin as a first-line treatment in advanced soft tissue sarcomas, and the strength of the data presented reinforces our belief that the linker technology platform can be applied to a broad range of cancer treatments,” said CYTR President and CEO Steven A. Kriegsman. “We look forward to advancing our aldoxorubicin second-line program into a Phase 3 pivotal trial in the first quarter of 2014 as well as evaluating aldoxorubicin as treatment for malignant glioblastoma (brain cancer) and HIV-related Kaposi’s sarcoma.”

In the trial 123 patients aged 18-80 years with histologically confirmed metastatic, locally advanced or unresectable soft tissue sarcomas were randomized 2:1 to receive 350 mg/m2 aldoxorubicin (260 mg/m2 doxorubicin equivalents) IV or 75 mg/m2 doxorubicin IV. They were slated to receive those dosages every three weeks for up to six cycles. The presented findings indicate ldoxorubicin can be administered at doses greater than 3 1/2 x the standard doxorubicin dose with similar or fewer systemic side effects. A significantly higher percentage of patients receiving aldoxorubicin are still active, have received at least 4 or 6 cycles of treatment, and have a greater number of tumor responses and stable disease. Patients in the trial treated with ldoxorubicin had a higher Overall Response Rate (ORR) (22%) compared with those treated with doxorubicin (0%) (p=0.004). In addition, a lower percentage of patients treated with aldoxorubicin (32%) showed progressive disease compared with patients treated with doxorubicin (50%) at the time of analysis.

The findings further showed 24 serious adverse effects associated with aldoxorubicin therapy patients as opposed to 6 serious adverse effects with doxorubicin-receiving patients. All of these effects were resolved and did not require treatment discontinuation. One treatment-related death in a patient treated with doxorubicin was reported.

A higher percentage of aldoxorubicin patients completed four cycles of treatment compared with doxorubicin patients (59 vs. 22, respectively) and six cycles of treatment (45 vs. 14, respectively). A similar percentage of aldoxorubicin patients (15%) and doxorubicin patients (16%) experienced neutropenic fever, and a higher percentage of doxorubicin patients (22%) had decreased cardiac output compared with aldoxorubicin patients (11%), as measured by a 15% decrease in left ventricular ejection fraction. No patient treated with aldoxorubicin had ejection fractions below 50% of their institutional norm versus 9.4% of patients that had received doxorubicin. Most importantly, there was no clinically significant reduction in cardiac function in the aldoxorubicin patients despite receiving 3 ½ times the standard dose of doxorubicin.

About MissionIR

MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.

To sign up for The MissionIR Report, please visit

To connect with MissionIR via Facebook, please visit

To connect with MissionIR via Twitter, please visit

Please read FULL disclaimer on the MissionIR website:

Forward-Looking Statement:

This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.