CytRx Receives Written FDA Communication Regarding Partial Clinical Hold for Aldoxorubicin Clinical Trials

CytRx Corporation (NASDAQ: CYTR), abiopharmaceutical research and development company specializing in oncology,today announced that the Company has received written notice from the UnitedStates Food and Drug Administration (FDA) that its clinical trials foraldoxorubicin have been placed on partial clinical hold. The news supplementsand is consistent with the prior verbal communications from the FDA.As previously announced, all currently enrolled patients can continuereceiving aldoxorubicin treatment, or comparator drugs, as per studyprotocols, but no new patients can be enrolled until the clinical hold islifted. At the FDA's request, the Company will amend all aldoxorubicin studyprotocols to include an appropriate inclusion/exclusion criteria, anadditional patient screening assessment and an evaluation of serumelectrolytes prior to aldoxorubicin administration. CytRx is workingdiligently in collaboration with the FDA to seek the release of the clinicalhold and resume enrollment in its clinical studies.CytRx currently believes that the partial hold issue will be expeditiouslyresolved and that enrollment rates and timelines for its ongoing trials willremain materially unchanged, subject to FDA timing. The Company currentlyexpects to announce preliminary results from the ongoing Phase 2 clinicaltrial of aldoxorubicin in Kaposi's Sarcoma in the first half of 2015 andpreliminary results from the ongoing Phase 2 clinical trial of aldoxorubicinin glioblastoma multiforme in the first half of 2015. CytRx remains committedto completing enrollment of its ongoing pivotal global Phase 3 trial insecond-line soft tissue sarcoma by the end of 2015.About AldoxorubicinThe widely used chemotherapeutic agent doxorubicin is delivered systemicallyand is highly toxic, which limits its dose to a level below its maximumtherapeutic benefit. Doxorubicin also is associated with many side effects,especially the potential for damage to heart muscle at cumulative dosesgreater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novelsingle-molecule linker that binds directly and specifically to circulatingalbumin, the most plentiful protein in the bloodstream. Protein-hungry tumorsconcentrate albumin, thus increasing the delivery of the linker molecule withthe attached doxorubicin to tumor sites. In the acidic environment of thetumor, but not the neutral environment of healthy tissues, doxorubicin isreleased. This allows for greater doses (3 ½ to 4 times) of doxorubicin to beadministered while reducing its toxic side effects. In studies thus far therehas been no evidence of clinically significant effects of aldoxorubicin onheart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.