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January 23, 2014
06:33 EDTCYTRCytRx begins Phase 2 clinical trial with aldoxorubicin for Kaposi's sarcoma
CytRx has initiated a Phase 2 clinical trial to determine preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposiís sarcoma. The primary objective of preliminary efficacy will be determined through evaluation of the size, number and nodularity of skin lesions, and the company will evaluate the level of aldoxorubicin uptake into lesions. CytRx plans to discuss a pathway for the registration of aldoxorubicin for KS with the FDA if the data are positive. The company expects to announce data from this Phase 2 clinical trial in Q2 2015.
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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