CytRx to Hold Conference Call Today at 10:00 a.m. Eastern Time to Discuss Favorable Results from INNO-206 Clinical Trial in Soft Tissue Sarcoma
77% of evaluable advanced soft tissue sarcoma patients administered INNO-206 at the maximum tolerated dose showed clinical benefit of more than four months following treatment
Company plans to meet with the FDA to discuss a potential Phase 3 pivotal trial with INNO-206 as a third-line therapy in soft tissue sarcoma patients
LOS ANGELES--(BUSINESS WIRE)--Jun 4, 2012 - CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, will hold a conference call to discuss favorable clinical results from the Phase 1b/2 clinical trial with INNO-206 in patients with advanced soft tissue sarcoma and next steps for the INNO-206 program in this indication.
In a press release issued Sunday, June 3, 2012, CytRx reported that clinical benefit defined as partial response and stable disease of at least four months following treatment with up to eight cycles of INNO-206 at the maximum tolerated dose was shown in 10 of 13 (76.9%) of evaluable patients with relapsed or refractory soft tissue sarcoma.
In addition, best response for the 13 evaluable soft tissue sarcoma trial subjects included the following:
- Five (38.5%) achieved partial response, as defined as tumor shrinkage of more than 30%
- Seven (53.8%) showed prolonged stable disease (defined as tumor shrinkage <30% from baseline or tumor growth < 20% from the nadir)
- Eight (61.5%) had tumor shrinkage
- Five of eight patients (62.5%) who demonstrated either partial responses or prolonged stable disease after treatment with INNO-206 had been previously treated with doxorubicin and had failed to respond
There were no observed cardiac toxicities and no drug-related patient deaths. The most common adverse event, neutropenia, resolved prior to the start of the subsequent treatment cycle, and is also observed with doxorubicin treatment.
Median estimated progression-free survival for advanced soft tissue sarcoma patients in the trial was 6.4 months with a range of 1.0 to more than 10.7 months. This compares favorably with the historical median progression-free survival for this patient population of approximately 3 months.
The presentation at ASCO was made 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. Dr. Chawla is a world-renowned expert in soft tissue sarcoma treatment who has evaluated most chemotherapies being tested in this indication. The poster, entitled “Phase 1b/2 Study of INNO-206 (EMCH-doxorubicin) in Patients with Soft Tissue Sarcoma,” was authored by Dr. Chawla, Victoria S. Chua, Andrew Hendifar, M.D., Doris Quon and Sandeep Nagre of the Sarcoma Oncology Center; Kristen N. Ganjoo, M.D. of Stanford University; Kamalesh Sankhala, M.D. of the University of Texas Health Science Center; and Scott Wieland, Ph.D. and Daniel Levitt, M.D., Ph.D. of CytRx.
“The Phase 1b/2 clinical results are exciting and highly supportive of the continued evaluation of INNO-206 as a first-line therapy in patients with advanced soft tissue sarcomas in CytRx's ongoing international Phase 2b clinical trial,” stated Dr. Chawla. “These data are even more impressive given the advanced stage of disease of the trial patients and the fact that these patients had already either not responded to or relapsed after being treated with, on average, two prior therapies. Additionally the lack of cardiac toxicity thus far is significant, as this reduces the potential for cardiac safety issues that are associated with standard doxorubicin and limits its clinical efficacy. I was impressed by the progression-free survival of approximately 6.4 months, which is longer than the 4.4 month PFS seen with pazopanib treatment in a very similar patient population. Pazopanib, commercially known as Votrient, was recently approved by the FDA as a second-line treatment for soft tissue sarcomas.”
|Start time:||10:00 a.m. Eastern time (7:00 a.m. Pacific time)|
|Dial-in Number:||(888) 463-4383 (U.S. and Canada) or (706) 679-5355 (international callers)|
|Speakers:||Sant P. Chawla,
M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in
Santa Monica, Calif., and the trial's lead investigator
Kriegsman, President and Chief Executive Officer of CytRx
|Daniel Levitt, MD,
Ph.D., Chief Medical Officer of CytRx
A webcast and slide presentation 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 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 Phase 2 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.
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 2b clinical trial for INNO-206 as a treatment for soft tissue sarcomas and the Phase 2 clinical trial in patients with pancreatic cancer, the risk that any future human testing of INNO-206 might not produce results similar to those seen in the Company's Phase 1b/2 clinical trial for INNO-206 in patients with advanced solid tumors, 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.
Contact: Investor Relations
Legend Securities, Inc.
Posted: June 2012