CytRx to Present Additional Data from its Phase 1b/2 Clinical Trial Combining Aldoxorubicin with Ifosfamide/Mesna at the CTOS 2015 Annual Meeting
Eight of Ten Treated Patients Have Demonstrated Tumor Shrinkage, with Three Partial Responses
LOS ANGELES, Oct. 28, 2015 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that a poster titled "A Phase 1b/2 Study of Aldoxorubicin plus Ifosfamide/Mesna in Untreated Sarcoma Patients" will be presented at the 20th Annual Connective Tissue Oncology Society (CTOS) Annual Meeting in Salt Lake City, Utah, November 4 - 7, 2015. The poster will discuss the trial design and current results of CytRx's on-going clinical trial in patients with metastatic soft and non-soft tissue sarcomas. In this study, 7 subjects received 170 mg/m2 aldoxorubicin, and 3 subjects received 250 mg/m2 aldoxorubicin (125 or 185 mg/m2 doxorubicin equivalents), administered intravenously every 4 weeks. All patients also received 1 gram/m2/day ifosfamide/mesna administered as a continuous 24 hour infusion for up to 14 days, every 4 weeks. As of September 30, 2015, 8 subjects demonstrated tumor shrinkage, with 3 subjects having documented partial responses. Six subjects are still receiving treatment. Grade 3 or 4 adverse events included neutropenia (90%), anemia (70%), nausea or vomiting (10%) and febrile neutropenia (10%). No subject exhibited cardiotoxicity by echocardiogram.
Dr. Sant Chawla M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center and principal investigator for this trial stated, "The use of doxorubicin with ifosfamide and mesna remains a treatment option for many sarcoma patients. Replacing doxorubicin with aldoxorubicin may lead to improved clinical outcomes for these first-line sarcoma patients, since we already know that aldoxorubicin demonstrated superiority to doxorubicin in the previously completed Phase 2b trial in first-line tissue sarcomas."
"The presentation of the Phase 1b/2 clinical trial data at CTOS demonstrates to the sarcoma community the potential use of aldoxorubicin as part of a multi-drug regimen to treat sarcomas," said Steven A. Kriegsman, CytRx's Chairman and Chief Executive Officer. "The on-going trial will generate important dosing, safety and efficacy data in treatment-naive patients. We remain excited about the prospects of aldoxorubicin in our pivotal global Phase 3 trial in sarcoma patients that have previously received chemotherapy, with top-line data expected in the second half of 2016."
Phase 1b/2 Trial Design
Aldoxorubicin is administered at escalating doses by intravenous infusion (IVI) on Day 1 every 28 days, and 1 gm/m2/day of ifosfamide and an equivalent dose of mesna is administered via continuous infusion with a portable at-home pump for up to 14 days every 28 days starting on Day 1 of each cycle, until disease progression, unacceptable toxicity or the patient withdraws consent. The primary objective of the trial is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in patients with metastatic, locally advanced, or unresectable STS as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight. The secondary objective of the trial is to evaluate the activity of aldoxorubicin in combination with ifosfamide/mesna in this population, assessed by overall response rate (ORR), progression-free survival (PFS) and PFS at 4 and 6 months. This Phase 1b/2 trial is being conducted at the Sarcoma Oncology Center in Santa Monica, California.
About Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2015 more than 11,900 new cases were diagnosed in the U.S. and approximately 4,900 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.
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 2,000 mg/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 is also seeking to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies. CytRx has initiated under a special protocol assessment a pivotal Phase 3 global clinical trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx is currently evaluating aldoxorubicin in a global Phase 2b clinical trial in small cell lung cancer, a Phase 2 clinical trial in HIV-related Kaposi's sarcoma, a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer), a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. 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 clinical trial 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. 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 testing of aldoxorubicin, the risk that any future clinical testing of aldoxorubicin might not produce results similar to those discussed in this press release, 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, 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.
David J. Haen
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