CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced 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). 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.
“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.”
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. (Original Source)
Shares of Cytrx closed yesterday at $3.13, up $0.01 or 0.32%. CYTR has a 1-year high of $5.42 and a 1-year low of $1.98. The stock’s 50-day moving average is $2.96 and its 200-day moving average is $3.12.
On the ratings front, Oppenheimer analyst Christopher Marai reiterated a Buy rating on CYTR, with a price target of $10, in a report issued on November 5. The current price target implies an upside of 219.5% from current levels. According to TipRanks.com, Marai has a total average return of 26.2%, a 63.0% success rate, and is ranked #21 out of 3644 analysts.
CytRx Corp is a biopharmaceutical research and development company specializing in oncology. Its oncology pipeline includes three clinical-stage drug candidates in various stages of development: Aldoxorubicin, Tamibarotene, and Bafetinib.