CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that the Data Safety Monitoring Committee overseeing the Company’s global Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) has recommended conducting the clinical trial through completion. Enrollment of at least 140 evaluable patients is expected in the first quarter of 2013.
“The Committee’s recommendation indicates that no significant safety issues have been seen with tamibarotene in the international Phase 2b clinical trial as we near enrollment completion with tamibarotene’s use in combination with potent chemotherapy agents in patients with advanced NSCLC,” said CytRx CEO Steven A. Kriegsman. “We are one step closer to completing this important clinical trial and further assessing tamibarotene in a potential multibillion dollar market, which is a major priority for our Company and our shareholders.”
Subjects with stage IIIb or IV NSCLS who have not received prior non-adjuvant chemotherapy are being enrolled in the blinded, randomized clinical trial at sites in the U.S., Bulgaria, India, Mexico, Russia and Ukraine. Trial patients are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival and quality-of-life in this population, among other measures. The Data Safety Monitoring Committee is an independent group of oncologists and biostatisticians who monitor the safety and efficacy of the Phase 2b trial.
“Tamibarotene is an orally available, rationally designed, synthetic retinoid compound that is 10-times more potent than all-trans retinoic acid (ATRA) and was designed to avoid several side effects of ATRA,” said Daniel Levitt, MD, Ph.D., CytRx’s Executive Vice President and Chief Medical Officer. “This event is significant due to favorable results from a single-center clinical trial in patients with advanced NSCLC that compared treatment with ATRA added to a regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus cisplatin alone. Patients who received the regimen with ATRA showed improved response rates of 55.8% versus 25.4%, increased progression-free survival of 8.9 months versus 6.0 months, and a 14-month median extension of life.”
CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC, and retains an option to expand its licenses for the use of tamibarotene in other fields in oncology.
About Non-Small-Cell Lung Cancer
This year more than 228,000 new cases of lung cancer will occur in the U.S. and more than 1.5 million worldwide. Deaths due to lung cancer account for the majority of cancer-related deaths (approximately 160,000 in the U.S. and approximately 1.4 million worldwide) and the five-year survival ranges between 8-15%. NSCLC accounts for 85-90% of all lung cancers, and claims more lives than breast, prostate and ovarian cancer combined.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes two programs in clinical development for cancer indications: aldoxorubicin (formerly known as INNO-206) and tamibarotene. With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, and has initiated a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors, a Phase 2 trial for patients with advanced pancreatic ductal adenocarcinomas and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors. The Company has held a positive meeting with the FDA to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and has submitted a special protocol assessment related to this trial. Tamibarotene is being tested in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer. The Company completed its evaluation of a third drug candidate, bafetinib, in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the outcome, timing and results of CytRx's planned Phase 2b clinical trial for tamibarotene as a treatment for NSCLC, uncertainties regarding regulatory approvals for current and future clinical testing of tamibarotene and the scope of the clinical testing that may eventually be required by regulatory authorities for tamibarotene, the significant time and expense that will be incurred in developing any of the potential commercial applications for tamibarotene, including for NSCLC, the risk that any future human testing of tamibarotene for NSCLC might not produce results similar to those seen with ATRA, risks related to CytRx's ability to manufacture its drug candidates, including tamibarotene, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of tamibarotene, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.