CytRx Reaches Patient Enrollment Target in Global Phase 2b Clinical Trial with Tamibarotene as First
CytRx Reaches Patient Enrollment Target in Global Phase 2b Clinical Trial with Tamibarotene as First-Line Treatment for Non-Small-Cell Lung Cancer
Top-Line trial results expected in the second half of 2013
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NAS: CYTR) , a biopharmaceutical research and development company specializing in oncology, announced that enrollment of 140 evaluable patients has been completed in the Company's global Phase 2b clinical trial with its oral retinoid compound tamibarotene in combination with chemotherapeutic agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC).
"Tamibarotene could represent a multi-billion dollar market opportunity as a breakthrough in the treatment of NSCLC," said CytRx CEO Steven A. Kriegsman. "We are delighted to have reached this major milestone in the clinical trial and expect to report top-line results from this trial in the second half of this year."
More deadly than colon, breast and prostate cancers combined, lung cancer has a five-year survival rate of between 8-15%. Each year more than 220,000 new cases of this cancer are reported in the U.S. and more than 1.5 million cases reported worldwide. NSCLC accounts for approximately 85% of all lung cancers, and by 2015, the market for this cancer is projected to reach $13.3 billion.
Patients with stage IIIB or IV squamous or adenocarcinoma NSCLC who had not received prior non-adjuvant chemotherapy have been enrolled in the double-blind Phase 2b trial in clinical sites in the U.S., Bulgaria, India, Mexico, Russia and Ukraine. Patients are randomized for treatment in up to six cycles with paclitaxel plus carboplatin, with half receiving tamibarotene and half receiving placebo. The primary endpoint of the clinical trial is progression-free survival, and secondary endpoints include response rate, overall survival and RAR beta expression, a potential biomarker for responders.
"We made the decision to pursue this indication due primarily to results from a single-center Phase 2 clinical trial in which all trans-retinoic acid (ATRA) added to a regimen of paclitaxel plus cisplatin produced far superior results in late-stage NSCLC patients than a regimen of paclitaxel plus cisplatin alone," said Daniel Levitt, MD, Ph.D., CytRx's Executive Vice President and Chief Medical Officer. "In fact, response rates for patients receiving ATRA in this trial increased two-fold, progression-free survival increased by three months and median overall survival increased 14 months. Those results were published in the July 2010 issue of the peer-reviewed Journal of Clinical Oncology."
Tamibarotene was developed to be superior to ATRA, an approved retinoid, by binding to its molecular target more selectively. In preclinical models, tamibarotene has proven to be 10 times more potent than ATRA with milder side effects. CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC. Tamibarotene is currently marketed in Japan for a rare form of leukemia.
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 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 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.
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