LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced that complete data from the Company’s Phase 1b/2 clinical trial with its proprietary doxorubicin tumor-targeting conjugate INNO-206 in patients with advanced solid tumors (primarily soft tissue sarcomas) will be featured in a poster presentation at the 2012 annual meeting of the American Society of Clinical Oncology (ASCO) being held at McCormick Place in Chicago. The poster will be presented by the trial’s principal investigator Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif., on Sunday, June 3, 2012, between 8:00 a.m. and 12:00 noon Central time.
“The data being presented at ASCO are from 25 patients with advanced solid tumors, primarily soft tissue sarcomas, who have failed other therapies and have completed up to 8 treatment cycles with INNO-206. These patients are receiving INNO-206 at a dose shown to deliver doxorubicin safely and tolerably at approximately three and one-half times the standard doxorubicin dose administered to sarcoma patients," stated Dr. Chawla. “In an interim look late last year at data from six trial patients who had completed four treatment cycles with INNO-206 at this dose level, two showed tumor shrinkage of more than 30 percent and four had stable disease. Complete data from the study will be presented in the poster.”
“Dr. Chawla is a world-renowned expert in the treatment of soft tissue sarcomas, having studied virtually every important drug being tested in this indication. We are grateful he has agreed to present the poster at ASCO and to join us for our investor call to discuss the data from his perspective as a preeminent sarcoma expert and as lead investigator for the trial,” said CytRx President and CEO Steven A. Kriegsman. “Based on the results of this trial we are planning to implement a Phase 3 study within the next year.”
Patients with advanced soft tissue sarcoma who can no longer be treated with surgery and have relapsed or were refractory to prior chemotherapies have a poor prognosis. Progression-free survival for this group is approximately 3 months, and median overall survival is approximately 9-10 months with less than 15% of these patients living past three years. CytRx holds worldwide rights to INNO-206, which has been granted orphan drug designation by the FDA for the treatment of patients with soft tissue sarcomas.
Dr. Chawla also is acting as principal investigator in a multicenter, international Phase 2b trial with INNO-206 as a first-line treatment for patients with advanced soft tissue sarcoma. This trial is designed to compare therapeutic treatment with INNO-206 head-to-head with doxorubicin with the goal of proving the superiority of INNO-206. Enrollment in the trial is expected to be completed in late 2012 or early 2013.
CytRx also recently initiated a Phase 2 clinical trial evaluating the preliminary efficacy and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have progressed after receiving two prior therapies. Daniel Von Hoff, M.D., Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute (TGEN), is serving as the clinical trial's principal investigator. Some data from this trial could be reported as early as the end of 2012.
ASCO Press Release and Conference Call
CytRx will issue a press release Sunday, June 3 in conjunction with the poster presentation at ASCO announcing complete clinical data from the Phase 1b/2 trial.
The Company will then host an investor conference call on Monday, June 4 at 9:00 a.m. Central time (10:00 a.m. Eastern time) featuring Dr. Chawla and CytRx management to discuss the clinical trial data and next steps for the INNO-206 program in soft tissue sarcoma. To access the conference call, dial (888) 463-4383 (U.S. and Canada) or (706) 679-5355 (international callers). A webcast also will be available on the investor relations section of the CytRx website. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial 855-859-2056 (U.S. and Canada) or 404-537-3406 (international callers) and enter the conference ID number: 77958605.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its ongoing Phase 1b/2 clinical trial primarily in the same indication, and recently initiated a Phase 2 trial for patients with advanced pancreatic ductual adenocarcinomas. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of 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 the Company, visit www.cytrx.com.
Forward-Looking Statements
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 clinical trials with INNO-206, including the Phase 1b/2 clinical trial for INNO-206 in patients with advanced solid tumors and the Phase 2b clinical trial for INNO-206 as a treatment for soft tissue sarcomas, uncertainties regarding regulatory approvals for current and future clinical testing, including CytRx’s planned Phase 3 clinical trial for INNO-206, and the scope of the clinical testing that may eventually be required by regulatory authorities, the risk that INNO-206 might not show greater efficacy than doxorubicin notwithstanding the administration of higher doses than the standard of care, the risk that additional longer-term dosing of INNO-206 might cause adverse events not seen to date in CytRx's Phase 1b/2 trial, uncertainties regarding whether INNO-206 effectively targets doxorubicin to tumors, the significant time and expense that will be incurred in developing any of the potential commercial applications for INNO-206, including for soft tissue sarcomas, risks related to CytRx's ability to manufacture its drug candidates, including INNO-206, 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 INNO-206, 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.