LOS ANGELES, Oct. 17, 2014 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that data regarding the Company's Phase 2b global clinical trial of aldoxorubicin for the treatment of first-line soft tissue sarcoma (STS) will be presented in a moderated paper presentation at the 2014 Connective Tissue Oncology Society (CTOS) Annual Meeting which is being held October 15-18, 2014, in Berlin, Germany. Due to the longer than expected survival of patients in the clinical trial, there have not been a sufficient number of survival events to enable the Company to report data on overall survival, a secondary endpoint of the study.
Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center and principal investigator of the trial, will present results from CytRx's 123-subject multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS). In this trial, subjects with advanced soft tissue sarcomas were randomized 2:1 to receive either 350 mg/m2 of aldoxorubicin (83 subjects) or 75 mg/m2 of doxorubicin (40 subjects) every 3 weeks for up to 6 cycles. As planned, the study will continue to track survival events and final results may be reported by the end of 2014 if the expected number of events occurs.
"Although it is too early to make any definitive assessment of the Phase 2b survival data, our early assessment is encouraging," said Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center, and principal investigator of the trial. "As previously reported, aldoxorubicin has already demonstrated statistically significant improvements in progression-free survival, as well as promising improvements in tumor shrinkage and overall response rates."
"Even though the clinical trial was not powered to show statistically significant differences in overall survival due to the relatively small number of patients, we are hopeful that a positive trend favoring the aldoxorubicin arm of the trial will be observed," said Steven A. Kriegsman, CytRx President and Chief Executive Officer. "Overall survival is event driven. Only a portion of the required events have occurred – meaning patients are living longer than expected, which is the ultimate goal of our oncology program. We will report overall survival when the expected number of survival events occurs.
The full Phase 2b PFS, PFS at 6 months, and Objective Response Rate (ORR) data, as presented at ASCO 2014, can be found here.
In addition to the moderated paper presentation given by Dr. Chawla, CytRx was also selected for a poster presentation discussing the cardiac safety of aldoxorubicin and a publication-only paper discussing the pharmacokinetics of aldoxorubicin for the treatment of STS. These data support the ongoing and planned clinical trials that CytRx is conducting in patients across various cancer types, including STS, glioblastoma multiforme (GBM), Kaposi's sarcoma, and small cell lung cancer.
A summary of the data presented by CytRx at the conference is below:
Moderated Paper Presentations/Discussions
Title: "Update on Phase 2B Trial of Aldoxorubicin Versus Doxorubicin as First-Line Treatment for Patients with Advanced Soft Tissue Sarcomas"
Presenter: Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center and Principal Investigator
Date and time: Friday, October 17, 2014, 1:00 – 2:00 PM (local time)
Session: Medical Oncology
Location: Potsdam I & II
Title: "Evaluation of the Cardiac Safety of Aldoxorubicin, A Novel Albumin-Binding Doxorubicin Prodrug"
Presenter: Daniel Levitt, M.D., Ph.D., Executive Vice President and Chief Medical Officer, CytRx Corporation
Date and time: Thursday, October 16, 2014, 5:30 – 6:30 PM (local time)
Session: Poster Session I
Location: Potsdam II & IV
Title: "Pharmacokinetics of Aldoxorubicin, A Novel Albumin-Binding Doxorubicin Prodrug for the Treatment of Soft Tissue Sarcoma"
Presenter: Scott Weiland, Senior Vice President, Drug Development, CytRx Corporation
About the Phase 2b Study Design in First-Line Soft Tissue Sarcoma
In this 123-subject, 31-center Phase 2b trial, subjects with advanced soft tissue sarcomas were randomized 2:1 to receive either 350 mg/m2 of aldoxorubicin (83 subjects) or 75 mg/m2 of doxorubicin (40 subjects) every 3 weeks for up to 6 cycles. Subjects were then followed every 6 weeks with CT scans to monitor tumor size. Two approaches were used to evaluate the efficacy of aldoxorubicin compared to doxorubicin in patients with soft tissue sarcomas: assessment by the study investigators, as well as assessment by a blinded central laboratory review. The primary endpoint was PFS and secondary endpoints included PFS at 6 months for each group, ORR (complete and partial) and OS.
About Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.
The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has initiated under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx is currently evaluating aldoxorubicin in a global Phase 2b clinical trial in small cell lung cancer, a Phase 2 clinical trial in HIV-related Kaposi's sarcoma, a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer), a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, based on novel linker technologies that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. For more information about CytRx Corporation, visit www.cytrx.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx's clinical trials, the timing or FDA approval of projected commercial sales of aldoxorubicin, the risk that overall survival data seen in the ongoing Phase 2b clinical trial in STS might not follow the trends discussed in this press release, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in past human or animal testing, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
David J. Haen
Vice President, Business Development and Investor Relations
SOURCE CytRx Corporation