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January 8, 2014
08:40 EDTCYTRCytRx reports additional analyses supporting results from Phase 2 trial
CytRx reported positive results from additional statistical analyses that further support the previously announced highly positive top-line efficacy results from a 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. Additional analysis determined hazard ratios for the primary endpoint of progression-free survival by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. The hazard ratio for investigator-read scans is 0.37, reflecting a 63% reduction in the risk of disease progression; and the hazard ratio for central lab scans is 0.59, reflecting a 41% reduction in the risk of disease progression. Hazard ratios the likelihood that the study endpoint will be reached during a given period are an important measure of the reliability and uniformity of the absolute data for PFS, as presented below. Hazard ratios where the upper limit is less than 1 indicate that there is a significant difference between the two study groups. CytRx also reported that a Kaplan-Meier analysis of the trial results, which describes the time it takes for tumors to progress in individual patients, showed significant improvement in subjects treated with aldoxorubicin versus subjects treated with doxorubicin. CytRx expects to present full study results for this clinical trial at the American Society for Clinical Oncology Meeting in June, 2014 in Chicago, Illinois.
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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