CytRx Corporation operates as a biopharmaceutical research and development company that specializes in oncology. Clinical Development Programs Aldoxorubicin The company is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its modified version of the chemotherapeutic agent, doxorubicin. Aldoxorubicin combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without the major dose-limiting toxicities seen with administration of doxorubicin alone. Aldoxorubicin is a conjugate of the chemotherapeutic agent doxorubicin that binds to circulating albumin in the bloodstream and is believed to concentrate the drug at the site of tumors. In the first quarter of 2014, the company initiated under an special protocol assessment granted by the U.S. Food and Drug Administration a pivotal, global Phase 3 trial of aldoxorubicin as a therapy for patients with soft tissue sarcoma (STS) whose tumors have progressed following treatment with chemotherapy. The company is 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. It has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for STS, 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. In addition to aldoxorubicin, the company is completing pre-clinical development for DK049, a novel anti-cancer drug conjugate that utilizes its Linker Activated Drug Release (LADR) technology. DK049 was created at its laboratory facility in Freiburg, Germany, and employs a proprietary linker that is both pH sensitive and requires a specific enzyme for the release of the cytotoxic payload. DK049 has demonstrated significant anti-tumor activity in multiple animal models implanted with human tumors, including non-small cell lung, ovarian and pancreatic cancers. The company anticipates filing an Investigational New Drug Application in the second half of 2016 prior to initiating a Phase 1 clinical trial. Research and Development Expenditures for research and development activities related to continuing operations were $43.4 million, for the year ended December 31, 2015. Intellectual Property As of December 31, 2015, the company held rights in 4 granted U.S. patents, 55 granted foreign patents, 3 pending U.S. applications, and 22 pending foreign patent applications covering aldoxorubicin and related technologies. The company’s intellectual property holdings relating to aldoxorubicin and related technologies include an exclusive license from KTB Tumorforschungs GmbH to U.S. and foreign patents and patent applications. Patents and applications that cover pharmaceutical compositions of aldoxorubicin, processes for their production, and their use in treatment methods, viral diseases, autoimmune diseases, and acute or chronic inflammatory diseases have unextended patent terms expiring between June 2020 and June 2034. Additionally, it has three pending U.S. provisional patent applications covering its LADR technology and DK049. License Agreements The company has an agreement with KTB for the license of patent rights held by KTB for the worldwide development and commercialization of aldoxorubicin. It also has a non-exclusive worldwide license to any additional technology that is claimed or disclosed in the licensed patents and patent applications for use in the field of oncology. History CytRx Corporation, a Delaware corporation, was founded in 1985. The company was incorporated in 1985.
cytrx corp (CYTR:NASDAQ CM)
11726 San Vicente Boulevard
Los Angeles, CA 90049
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