On December 1, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it has reached its enrollment target of 400 patients for the company’s pivotal global Phase 3 clinical trial of aldoxorubicin in patients with previously treated soft tissue sarcoma (STS) (Press release, CytRx, DEC 1, 2015, View Source;p=RssLanding&cat=news&id=2119175 [SID:1234508371]). Enrollment was originally estimated to be completed in Q1 2016. The Phase 3 trial is a randomized, comparative trial being conducted under a Special Protocol Assessment from the FDA at 79 sites in the United States, Canada, Israel, Australia, Western & Eastern Europe and Chile.
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"It is a true testament to the dedicated work of our clinical team, the enthusiasm of our participating physicians, and the willingness of patients to participate in our study that enrollment in our global pivotal Phase 3 clinical trial was completed ahead of schedule," said Steven A. Kriegsman, Chairman and CEO of CytRx. "We now expect to report the primary endpoint of top-line progression-free survival (PFS) in the first half of 2016, and pre-commercial launch activities are underway."
"As a member of the sarcoma research community, I am very excited to see the overwhelmingly positive response from my colleagues to this pivotal trial," said Sant P. Chawla, M.D., F.R.A.C.P., Principal Investigator and Director of the Sarcoma Oncology Center. This trial is the first to compare a single agent, aldoxorubicin, to five of the most commonly used treatment options for STS patients that have received prior chemotherapy. The rapid timeframe in which this Phase 3 trial reached its targeted enrollment reflects the desire of practitioners for more efficacious therapies."
Trial Design
This is a multicenter, randomized, open-label Phase 3 clinical trial designed to enroll approximately 400 late-stage patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to, or who have progressed following treatment with one or more systemic regimens of nonadjuvant 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 PFS and will be calculated after 191 events occur. Secondary endpoints include overall survival, response rates and safety. In January 2014, CytRx announced that it received approval from the FDA to amend the Phase 3 protocol to continue dosing patients with aldoxorubicin until disease progression as defined by RECIST 1.1 criteria. The ability to dose until disease progression creates the potential for substantially improved Phase 3 efficacy results.
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.
About Aldoxorubicin
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.