CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it has reached the target number of progression events in its pivotal, global phase 3 clinical trial with aldoxorubicin as a treatment for patients with second-line soft tissue sarcomas. In accordance with the statistical analysis plan which is incorporated in the Special Protocol Assessment (SPA) granted by the FDA, 191 events were required to trigger the analysis of the primary endpoint of progression-free survival (PFS). The events were reviewed and verified by an independent, blinded radiology organization contracted by CytRx to analyze all of the scans for the Phase 3 pivotal clinical trial.
“Reaching the number of events is an important milestone for the aldoxorubicin Phase 3 trial,” said Daniel Levitt, M.D., Ph.D., CytRx’s EVP and Chief Medical Officer. “Now we, along with our contract research organization, are in the process of collecting, verifying and analyzing all of the trial data from the 79 sites around the globe. While this is a large undertaking, we expect to have top-line results at the end of this quarter. We are continuing to actively treat and follow patients who have not progressed and are analyzing data to determine the overall survival and safety.”
“Aldoxorubicin represents an important new drug for treating patients with advanced soft tissue sarcomas,” commented Sant Chawla, M.D., F.R.A.C.P., Principal Investigator and the Director of the Sarcoma Oncology Center inSanta Monica, California. “The Phase 3 trial design is unique in that it is the first trial in soft tissue sarcoma to compare a single agent to five of the most commonly used treatment options. Like many in the sarcoma community, I eagerly look forward to the top-line results with aldoxorubicin.”
CytRx plans to discuss with the FDA initiating a rolling New Drug Application by the end of 2016, subject to the outcome of the Phase 3 pivotal trial. Pursuant to FDA approval, CytRx expects to launch aldoxorubicin in the United States as a treatment for patients with second-line soft tissue sarcoma in the second half of 2017.
Phase 3 Trial Design
The multicenter, randomized, open-label pivotal Phase 3 clinical trial enrolled 433 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 were 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 last Friday at $2.74, up $0.06 or 2.24%. CYTR has a 1-year high of $5.42 and a 1-year low of $1.55. The stock’s 50-day moving average is $2.57 and its 200-day moving average is $2.58.
On the ratings front, Cytrx has been the subject of a number of recent research reports. In a report issued on March 14, Jefferies Co. analyst Chris Howerton maintained a Hold rating on CYTR, with a price target of $2.50, which represents a potential downside of 8.8% from where the stock is currently trading. Separately, on March 11, FBR’s Christopher James maintained a Buy rating on the stock and has a price target of $8.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chris Howerton and Christopher James have a total average return of 3.5% and -11.5% respectively. Howerton has a success rate of 41.7% and is ranked #1617 out of 3775 analysts, while James has a success rate of 35.5% and is ranked #3613.
CytRx Corp. operates as a biopharmaceutical research and development company specializing in oncology. The company on the clinical development of aldoxorubicin oncology pipeline for the treatment of cancer. CytRx was founded on February 28, 1985 and is headquartered in Los Angeles, CA.