LOS ANGELES, Sept. 22, 2014 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that study designs and progress from two of the Company's key clinical trials of aldoxorubicin, a pivotal global Phase 3 clinical trial in relapsed/refractory soft tissue sarcomas (STS) and a global Phase 2b clinical trial in small cell lung cancer, will be presented at the European Society for Medical Oncology (ESMO) 2014 Congress being held September 26-30, in Madrid, Spain. Titled, "Multicenter Phase 3 Study of Efficacy and Safety of Aldoxorubicin Versus Investigator's choice for Relapsed/Refractory Soft Tissue Sarcomas" (Poster # 1461TiP) and "Phase 2 Study of Aldoxorubicin Versus Topetecan for Relapsed/Refractory Small Cell Lung Cancer" (Poster #1478TiP), the posters will available beginning at 12:45 pm CEST on Monday, September 29, 2014, in the conference's Poster Area, and will be made available on the Company's website at www.cytrx.com.
Sant Chawla, M.D., Director of the Sarcoma Oncology Center and principal investigator of the global Phase 3 pivotal STS study, commented, "Soft tissue sarcomas remain a serious unmet medical need, with poor prognoses and few effective treatment options. In earlier studies of STS, patients treated with aldoxorubicin as a single agent demonstrated good tolerability and highly statistically significant improvements over doxorubicin in multiple efficacy outcomes, including PFS. There is a tangible and growing enthusiasm within the treatment community for aldoxorubicin and this important, pivotal Phase 3 study, as we work towards understanding this drug candidate's potential to become a treatment of choice worldwide for STS."
"These ESMO presentations underscore the momentum among investigators behind our aldoxorubicin program, which is rapidly expanding into multiple tumor types," said CytRx CEO Steven A. Kriegsman. "By design, aldoxorubicin delivers anthracycline therapy to the tumor, avoiding many systemic effects such as cardiotoxicity, yet maintaining the broad activity of this therapeutic class with great potential to treat multiple cancers, including STS, glioblastoma, small cell lung, breast, and ovarian cancers, as well as multiple myeloma and acute myelocytic leukemia. We are highly encouraged by the response to and extremely rapid enrollment in our pivotal, global Phase 3 trial in relapsed/refractory soft tissue sarcomas, and look forward to the imminent start of our global Phase 2b trial in small cell lung cancer."
The Phase 3 study, which is being conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration, is a global, randomized, open-label prospective, multicenter study designed to enroll approximately 400 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to, or have progressed following treatment with, one or more systemic regimens of non-adjuvant chemotherapies. Trial patients are randomized 1:1 to be treated with aldoxorubicin or the investigator's choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide, dacarbazine, pazopanib (Votrient®), or gemcitabine plus docetaxel. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival, response rates and safety. Enrollment is on target to be completed by year-end 2015, with PFS data announced in mid-2016. Subject to FDA approval, the Company projects market launch in 2017.
The open-label Phase 2b clinical trial is expected to enroll approximately 132 patients (1:1 randomization) with extensive-stage SCLC who have relapsed or were refractory to prior chemotherapy. Patients will receive either aldoxorubicin or topotecan. The primary endpoint is progression-free survival (PFS) and the secondary endpoints are overall survival (OS), objective response rate (ORR), investigator-reported quality of life (ECOG PS) and treatment-related toxicities. PFS data are expected by mid-2016. The study, which is expected to begin enrolling patients imminently, will involve approximately 40 clinical trial sites in the U.S., Spain, Italy and Hungary.
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 the European Society for Medical Oncology
The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care. Since its founding in 1975 as a non-profit organization, the ESMO's mission has been to advance cancer care and cure.
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 has initiated a Phase 2 clinical trial in HIV-related Kaposi's sarcoma and a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma. 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 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