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March 31, 2014
07:02 EDTCYTRCytRx receives orphan medicinal product designation from EU for aldoxorubicin
CytRx Corporation announced that aldoxorubicin has received orphan medicinal product designation from the European Commission for the treatment of advanced soft tissue sarcomas. The designation is to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases. Aldoxorubicin is the companyís lead product candidate which combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of greater amounts of doxorubicin without several of the major dose-limiting toxicities seen with administration of doxorubicin alone. Aldoxorubicin has been granted orphan drug designation by the Office of Orphan Product Development of the U.S. Food and Drug Administration for the treatment of patients with soft tissue sarcomas and pancreatic cancer. Orphan Medicinal Product Designation provides up to 10 years of market exclusivity if the product candidate is approved for marketing in the European Union and the orphan designation is maintained. Aldoxorubicin is currently being evaluated in a global pivotal Phase 3 trial under a special protocol assessment as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also recently initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma, and a Phase 2 clinical trial in HIV-related Kaposiís sarcoma.
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September 9, 2014
06:06 EDTCYTRCytRx begins enrollment for Phase 1b clinical trial of aldoxorubicin
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