CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, 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 (SCLC), 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.
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 programme, 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 US 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 US, 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.
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.