Health & Fitness
Health and Fitness
Health and Fitness
Wed, September 28, 2011
Tue, September 27, 2011
Mon, September 26, 2011
CytRx to Substantially Increase Patient Enrollment in INNO-206 Phase 1b/2 Clinical Trial Principally in Patients with Soft Tiss
LOS ANGELES--([ BUSINESS WIRE ])--CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it is tripling the number of patients in its Phase 1b/2 clinical trial who will be treated with its tumor-targeting doxorubicin conjugate INNO-206 at the dose planned for its Phase 2b trial for the treatment of advanced soft tissue sarcomas. Six patients have already been treated at that dose, out of a total of 13 enrolled in the trial, and the Company now plans to add an additional 12 patients. The open-label safety and dose escalation Phase 1b clinical trial has now been designated a Phase 1b/2 trial, and is being conducted primarily in patients with advanced soft tissue sarcomas who have failed standard therapies.
"INNO-206a™s ability to safely and tolerably deliver doxorubicin at these levels is highly encouraging"
Patients in the Phase 1b/2 trial are receiving INNO-206 at 350mg/m2 every three weeks in six cycles. This dose delivers doxorubicin at levels 3-times higher than the dose of doxorubicin planned for the Companya™s Phase 2b trial control arm. To date, all patients in the Phase 1b/2 trial administered INNO-206 at this dose level have shown impressive tolerability and nearly all are continuing in the trial.
The trial is being conducted at the Sarcoma Oncology Center in Santa Monica, Calif., under the direction of Sant P. Chawla, M.D., F.R.A.C.P, a world-renowned expert in soft tissue sarcoma treatment who has studied virtually every important drug being tested in this indication. aINNO-206a™s ability to safely and tolerably deliver doxorubicin at these levels is highly encouraging," stated Dr. Chawla. "We are increasing patient enrollment in the Phase 1b/2 clinical trial based on the impressive preliminary results that I have observed and are optimistic about moving quickly into international Phase 2b clinical testing for the treatment of patients with advanced soft tissue sarcomas later this year."
CytRx President and CEO Steven A. Kriegsman said, aFor those suffering from soft tissue sarcomas, the only drug approved as a treatment by the U.S. Food and Drug Administration is doxorubicin. However, doxorubicina™s use is limited by its toxicity. We are pleased that, to date, patients enrolled in the Phase 1b/2 trial are able to tolerate doxorubicin administered via INNO-206 at doses that are substantially higher than doxorubicin alone. These initial safety and tolerability results increase our confidence in INNO-206a™s ability to safely deliver more drug directly to the tumor, which could increase efficacy.a
About INNO-206
INNO-206 is a novel conjugate of doxorubicin that binds covalently to albumin, the most abundant protein in blood plasma, and is circulated throughout the body. Doxorubicin is a standard chemotherapeutic treatment for a variety of cancers and is used either alone or in combination with other chemotherapy agents. INNO-206 is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues. This conjugate formulation has the potential to safely deliver greater amounts of doxorubicin directly to the tumor compared with standard doxorubicin treatment, which could lead to improved efficacy.
CytRx holds the exclusive worldwide rights to INNO-206 -- a platform technology designed to reduce adverse events by controlling drug release and preferentially targeting tumors. In addition to doxorubicin, several other chemotherapy agents have been attached to the linker used for INNO-206, including paclitaxel, cisplatin and methotrexate, and may be incorporated into future clinical development by the Company.
About Advanced Soft Tissue Sarcomas
Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis and limited options. Progression-free survival for patients with advanced soft tissue sarcomas is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years. Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival and are quite toxic.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. 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 plans to initiate a Phase 2b clinical trial as a treatment for soft tissue sarcomas in 2011, following its Phase 1b/2 dose escalation safety trial. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer, and is conducting a pharmacokinetic clinical trial in brain cancer. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit [ http://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 Phase 1b/2 clinical trial for INNO-206 in patients with advanced solid tumors or planned Phase 2b clinical trial for INNO-206 as a treatment for soft tissue sarcomas, 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, uncertainties regarding regulatory approvals for current and future clinical testing of INNO-206 and the scope of the clinical testing that may eventually be required by regulatory authorities for INNO-206, 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.
