During Tuesday’s trading session, CytRx Corp. (NASDAQ:CYTR) showed up on several scanners as one of the best-performing Nasdaq stocks. At one point in the session, shares of CytRx were up 12 percent before finishing the day up 4.3 percent on above-average trading volume (3.5 million shares). This represents another strong trading session for a company that has been among the Nasdaq’s best-performing equities over the past year. CytRx investors have enjoyed a whopping 335 percent return over the past 52 weeks. Based on Tuesday’s news, a much higher return is likely in store.
CytRx Corp. is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline is focused on the clinical development of aldoxorubicin, its improved version of the widely used chemotherapeutic agent doxorubicin. The company hopes that aldoxorubicin will eventually be capable of treating multiple indications, eliminating the need for doxorubicin.
On Tuesday morning, CytRx announced that it had received Food and Drug Administration approval to continue dosing patients with aldoxorubicin until disease progression in a Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas. Disease progression is defined as an increase in the size of measurable tumors by 20 percent or the development of a new tumor lesion. The company plans to begin the Phase 3 trial during the current quarter.
In the already completed Phase 2b trial, aldoxorubicin demonstrated highly statistically significant results. Both the investigator assessment and the central lab review concluded that patients treated with aldoxorubicin demonstrated an 80 to 100 percent improvement in progression free survival. The investigator-assessed median PFS was 8.4 months for aldoxorubicin patients, compared to just 4.7 months for doxorubicin patients. The central lab review median PFS was 5.7 months for aldoxorubicin patients compared to just 2.8 months for doxorubicin patients.
As investors can easily observe, the results demonstrated in the Phase 2b trial are overwhelmingly positive. Based on Tuesday’s news, the results could be even stronger. Since the FDA is now going to allow CytRx to extend dosing beyond six cycles, even greater progression-free survival efficacy results are likely to be observed in the Phase 3 trial.
In addition to the STS Phase 3 trial, investors should also be looking forward to additional data from CYTR’s Phase 2 trial in glioblastoma multiforme. The Phase 2 trial will evaluate aldoxorubicin for the treatment of unresectable GBM, a deadly form of brain cancer. The company anticipates releasing preliminary results in the second half of 2014. If successful, it is likely that shares would see a huge move higher given the difficulties that other companies have in trying to find a cure for GBM.
One of the primary reasons why aldoxorubicin may supplant doxorubicin is for safety and tolerability issues. While no cardiotoxicity has been seen thus far during the evaluation of aldoxorubicin, doxorubicin’s use is limited due to its potential to damage the heart. Because of its serious side effects and its red color, it’s easy to understand why doxorubicin has earned the nickname of “red death.” And it’s also easy to see why aldoxorubicin is a few steps away from becoming the new and improved standard of care in cancer treatment.