Three leading oncology conferences select aldoxorubicin Phase 1b/2 clinical trial results for presentation
CytRx’s Aldoxorubicin Clinical Data Presented at the ESMO 2012 Congress
Investor Relations
(NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, announced that favorable data from its Phase 1b/2 clinical trial with its tumor-targeting doxorubicin conjugate aldoxorubicin (formerly INNO-206) in patients with advanced soft tissue sarcoma was presented today at the Sarcoma Poster-Discussion Session (Hall H) at the ESMO (European Society of Medical Oncology) 2012 Congress in Vienna, Austria. The presentation, entitled “INNO-206 (aldoxorubicin) Is An Active Drug For Relapsed Soft Tissue Sarcoma,” was given by renowned sarcoma expert Sant P. Chawla, M.D., Director of the Sarcoma Oncology Center in Santa Monica, CA.
The data from the aldoxorubicin Phase 1b/2 clinical trial showed clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) with aldoxorubicin at the maximum tolerated dose in 10 of 13 (77%) evaluable patients with relapsed or refractory soft tissue sarcoma. The data from this clinical trial were first presented at the American Society of Clinical Oncology (ASCO) Conference on June 3, 2012.
“These clinical trial results with aldoxorubicin were introduced at ASCO, presented today at ESMO, and will be featured at the Connective Tissue Oncology Society (CTOS) Conference in Prague, Czech Republic, in November. We believe that the avid reception for presentation of the aldoxorubicin clinical data by leading oncology conferences is a testament to their importance and we are pleased that these clinical results are capturing the attention of the oncology community,” stated Steven A. Kriegsman, CytRx President and CEO.
“Although the trial data are derived from a small patient group, the fact that clinical benefit was seen in 77% of these patients is noteworthy, particularly given the advanced stage of disease,” said the clinical trial’s principal investigator and renowned sarcoma expert Sant P. Chawla, M.D., F.R.A.C.P. “Further, of the eight evaluable patients who were previously treated with doxorubicin and had either not responded or relapsed, five showed clinical benefit with aldoxorubicin. Among these, three showed prolonged partial responses with greater than 30% tumor shrinkage.”
Aldoxorubicin combines a proprietary linker technology with doxorubicin, a widely used chemotherapeutic agent that is dose-limited due to toxicity. The linker technology delivers doxorubicin to tumor sites where the delivery molecule is cleaved and the doxorubicin is released. The ability to deliver substantially more of the agent directly to the tumor site has the potential to improve the drug’s effectiveness while avoiding many of the side effects associated with systemic delivery.
The Company plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial for aldoxorubicin as therapy for patients with advanced soft tissue sarcomas who have relapsed after or were refractory to chemotherapy.
The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care. Since its founding in 1975 as a non-profit organization, the ESMO’s mission has been to advance cancer care and cure.
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: (formerly known as INNO-206) and . 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, recently initiated both 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, and plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. Tamibarotene is being tested in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and is in a Phase 2 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of a third drug candidate, , 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 .
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 aldoxorubicin, 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 aldoxorubicin 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 aldoxorubicin, and the scope of the clinical testing that may eventually be required by regulatory authorities, the risk that aldoxorubicin 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 aldoxorubicin might cause adverse events not seen to date in CytRx's Phase 1b/2 trial, uncertainties regarding whether aldoxorubicin effectively targets doxorubicin to tumors, the significant time and expense that will be incurred in developing any of the potential commercial applications for aldoxorubicin, including for soft tissue sarcomas, risks related to CytRx's ability to manufacture its drug candidates, including aldoxorubicin, 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 aldoxorubicin, 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.