CytRx Corporation CYTR, a
biopharmaceutical research and development company specializing in oncology,
today announced that the Company has received written notice from the United
States Food and Drug Administration (FDA) that its clinical trials for
aldoxorubicin have been placed on partial clinical hold. The news supplements
and is consistent with the prior verbal communications from the FDA.
As previously announced, all currently enrolled patients can continue
receiving aldoxorubicin treatment, or comparator drugs, as per study
protocols, but no new patients can be enrolled until the clinical hold is
lifted. At the FDA's request, the Company will amend all aldoxorubicin study
protocols to include an appropriate inclusion/exclusion criteria, an
additional patient screening assessment and an evaluation of serum
electrolytes prior to aldoxorubicin administration. CytRx is working
diligently in collaboration with the FDA to seek the release of the clinical
hold and resume enrollment in its clinical studies.
CytRx currently believes that the partial hold issue will be expeditiously
resolved and that enrollment rates and timelines for its ongoing trials will
remain materially unchanged, subject to FDA timing. The Company currently
expects to announce preliminary results from the ongoing Phase 2 clinical
trial of aldoxorubicin in Kaposi's Sarcoma in the first half of 2015 and
preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin
in glioblastoma multiforme in the first half of 2015. CytRx remains committed
to completing enrollment of its ongoing pivotal global Phase 3 trial in
second-line soft tissue sarcoma by the end of 2015.
About Aldoxorubicin
The widely used chemotherapeutic agent doxorubicin is delivered systemically
and is highly toxic, which limits its dose to a level below its maximum
therapeutic benefit. Doxorubicin also is associated with many side effects,
especially the potential for damage to heart muscle at cumulative doses
greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel
single-molecule linker that binds directly and specifically to circulating
albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors
concentrate albumin, thus increasing the delivery of the linker molecule with
the attached doxorubicin to tumor sites. In the acidic environment of the
tumor, but not the neutral environment of healthy tissues, doxorubicin is
released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be
administered while reducing its toxic side effects. In studies thus far there
has been no evidence of clinically significant effects of aldoxorubicin on
heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.
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