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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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May 21, 2015
09:04 EDTCYTRCytRx's aldoxorubicin shows positive Phase 2 results for brain cancer
CytRx announced positive updated results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme, a deadly form of brain cancer. The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. 18 study subjects have received between 1 and 14 cycles of aldoxorubicin, with 4 subjects continuing to receive aldoxorubicin treatment. 2 subjects diagnosed with tumor progression following aldoxorubicin treatment demonstrated no microscopic evidence of tumor tissue after resection. Fourteen of 18 subjects discontinued aldoxorubicin treatment, although there is a significant possibility that some of the patients experienced pseudo-progression. Following discontinuation of aldoxorubicin treatment, 10 of 14 subjects received treatment with bevacizumab for 1 to 14 cycles. Deaths have occurred in only 4 of 18 subjects to date, with survival duration so far of up to 10 plus months. Aldoxorubicin was well tolerated at both dose levels with all adverse events consistent with known doxorubicin toxicities, but not cardiotoxity.
May 12, 2015
09:36 EDTCYTRCytRx management to meet with Oppenheimer
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