(NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the 12 months ended December 31, 2012, and provided 2013 milestones for its clinical development programs.
“This is an inflection year for CytRx as data are expected from four clinical trials with our highly promising oncology drug compounds that address significant markets,” said President and Chief Executive Officer Steven A. Kriegsman. “We also are actively making preparations for a randomized, comparative, international Phase 3 clinical trial with aldoxorubicin as a second-line treatment in patients with soft tissue sarcomas. Subject to agreement from the FDA, we expect to initiate the trial in the second half of this year. The FDA is currently reviewing our request to conduct this trial under a special protocol assessment (SPA), which we filed in January.”
By reaching agreement with the FDA on a trial protocol under an SPA, the FDA deems that a Phase 3 clinical trial is acceptable for support of regulatory approval, subject to trial results. Favorable results from a Phase 1b/2 clinical trial with aldoxorubicin showed clinical benefit (partial response or stable disease at four months following treatment) in 77% of evaluable patients with advanced soft tissue sarcomas who had failed other therapies. CytRx holds exclusive worldwide rights to aldoxorubicin, the tumor-targeting conjugate of the commonly used chemotherapeutic agent doxorubicin.
CytRx expects in 2013 to report results from clinical trials with aldoxorubicin as follows:
- Second Quarter – Phase 1b clinical trial results from 24 patients with advanced solid tumors to determine the maximum tolerated dose (MTD) of a combination of aldoxorubicin and doxorubicin. The clinical trial will continue with the combination aldoxorubicin and doxorubicin administered at the MTD to an expansion group of patients with chondrosarcomas or chordomas to determine safety and preliminary efficacy in these normally chemotherapy-insensitive malignancies. The purpose of this trial is to extend the Company’s patent portfolio and potentially increase market penetration with aldoxorubicin for the treatment of patients with solid tumors.
- First Half – Pharmacokinetic results from an open-label, single-center Phase 1b clinical trial in patient with metastatic solid tumors.
- Second Half – Progression-free survival results from an international Phase 2b clinical trial in 105 patients comparing aldoxorubicin with doxorubicin as a first-line treatment for soft tissue sarcoma. This trial is being conducted under the direction of world-renowned expert in soft tissue sarcoma treatment Santa P. Chawla, M.S., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif.
“Additionally, we expect to report topline data in the second half of 2013 from our international Phase 2b clinical trial with tamibarotene in 140 evaluable patients with advanced non-small cell lung cancer (NSCLC),” added Mr. Kriegsman. “Lung cancer is the leading cause of cancer deaths around the world and is more deadly than colon, breast and prostate cancers combined. We believe that tamibarotene could be a breakthrough treatment for NSCLC. This is a major opportunity for CytRx with the NSCLC therapy market projected to reach $13.3 billion by 2015.