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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.
News For CYTR From The Last 14 Days
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January 22, 2015
09:34 EDTCYTRCytRx to host conference call
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09:09 EDTCYTRCytRx's Aldoxorubicin shows positive Phase 2b results for soft tissue sarcoma
CytRx reported positive overall survival results, the secondary endpoint, from its completed multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas. The OS results in 123 patients demonstrated that aldoxorubicin-treated patients demonstrated a 27% reduction in the risk of death compared to patients treated with doxorubicin, the current standard-of-care in this indication.In addition, aldoxorubicin-treated patients demonstrated a 41% likelihood of surviving more than 2 years, a 2-fold increase, compared to a 20% probability for doxorubicin-treated patients. Median overall survival was 16.0 months for aldoxorubicin-treated patients versus 14.4 months for doxorubicin treated patients. For treatment-naive patients, representing 90% of the patients in the clinical trial, median overall survival was 16.0 months for aldoxorubicin-treated patients versus 14.0 months for doxorubicin treated patients. The positive trend could be significantly improved, now that the FDA has permitted CytRx to dose aldoxorubicin in all trials until tumor progression.
January 20, 2015
09:11 EDTCYTROn The Fly: Pre-market Movers
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06:06 EDTCYTRFDA removes partial clinical hold for CytRx's aldoxorubicin clinical trials
CytRx announced that the FDA has removed the partial clinical hold on the Company's aldoxorubicin clinical trials. Enrollment and dosing of new patients is now permitted after study sites' Institutional Review Boards approve the revised trial protocols. CytRx currently believes that enrollment rates and timelines for its trials will remain materially unchanged. The Company expects to complete enrollment in its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015 and unblind the clinical data by mid-2016. Subject to FDA approval, CytRx's market launch of aldoxorubicin for second line soft tissue sarcoma is projected to commence in 2017.

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