LOS ANGELES -- (BUSINESS WIRE) -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, presented updated progression-free survival (PFS) and overall survival (OS) results from its completed Phase 1b/2 clinical trial of aldoxorubicin in patients with advanced soft tissue sarcoma (STS). The data were presented as part of CytRx’s Research and Development Day which took place Friday, May 2, 2014 at the Harvard Club in New York City.
Data from the Phase 1b/2 trial demonstrated that aldoxorubicin administered at its maximum tolerated dose (350mg/m2) showed a substantial increase in median PFS in patients with advanced soft tissue sarcoma (n=13). Partial responses were observed in 5 of 13 patients (38%) and stable disease was observed in 6 of 13 patients (46%). Median PFS of 6.4 months was initially reported at ASCO and ESMO; in the final reported data, observed median PFS had nearly doubled to 11 months, and median OS was 17 months. Notably, following 8 cycles of aldoxorubicin, two patients experienced no progression of disease for 23 and 15 months, respectively, despite no further treatment. Aldoxorubicin was generally well tolerated with no observed cardiotoxicities and no drug-related deaths.
“The data from this now completed study are certainly a promising advance and show that aldoxorubicin was clinically active and generally well tolerated in patients who are particularly difficult to treat given the advanced stage of their disease,” said Sant P. Chawla, M.D., F.R.A.C.P., principal investigator of the trial and renowned sarcoma expert. “There remains a high unmet need for patients with soft tissue sarcoma, especially since many relapse or stop responding to currently available treatments. I am also particularly encouraged by the long progression-free periods experienced by two patients in this study.”
“We are excited to see that the final data showed substantial improvement in median PFS over the previously-reported data, as well as impressive median overall survival. Importantly, the data from the Phase 1b/2 trial came after the administration of only 8 cycles of aldoxorubicin – for future clinical development, we are permitted to dose until progression, which could substantially extend the lives of sarcoma patients. We are actively enrolling patients in our pivotal global Phase 3 clinical trial in second-line STS and we look forward to keeping you updated on our progress,” said Steven A. Kriegsman, CytRx President and Chief Executive Officer. “We would like to thank Dr. Chawla for his tireless work with aldoxorubicin as a novel treatment candidate for sarcoma.”
Aldoxorubicin is currently being studied in a pivotal global Phase 3 clinical trial evaluating the efficacy and safety of aldoxorubicin as a second-line treatment for patients with STS under a Special Protocol Assessment with the FDA. CytRx is also conducting two Phase 2 clinical trials evaluating aldoxorubicin in patients with late-stage glioblastoma (GBM) and HIV-related Kaposi’s sarcoma.
The Phase 1b/2 clinical trial was conducted at the Sarcoma Oncology Center in Santa Monica, California.
The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m2.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx recently initiated, under a special protocol assessment, a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. The Company also recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx 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 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 relating to the outcome, timing and results of CytRx’s clinical trials, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in past human or animal testing, risks related to CytRx’s ability to manufacture its drug candidates 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 the Phase 3 clinical development of aldoxorubicin, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, 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.