Trading volumes and the price of a share of CytRx Corporation (CYTR) have exploded in Wednesday trading after the biotech said that its drug candidate improved survival rates without disease progression in patients with soft tissue sarcomas, compared to chemotherapy alone.
Soft tissue sarcoma is a cancer found in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue anywhere in the body. The American Cancer Society estimates that more than 11,400 new cases will be diagnosed in the U.S. this year and about 4,400 people will die from the disease.
In an ongoing 123-patient Phase 2b trial, patients with first-line metastatic, locally advanced or unresectable soft tissue sarcomas were treated with either CytRx’s aldoxorubicin or doxorubicin, a chemotherapeutic approved to treat several types of cancer, including leukemia, Hodgkin’s lymphoma, soft tissue sarcoma, multiple myeloma and more. Aldoxorubicin combines doxorubicin with a linker-molecule to bind with albumin in the blood to deliver higher amounts of doxorubicin to tumors without the toxicity that can limit the amount of doxorubicin that can be administered. In short, protein hungry tumors concentrate albumin, which in the case of aldoxorubicin is loaded with doxorubicin, a powerful tumor destroyer that is often delivered shy of its maximum therapeutic benefit because of the risk of adverse events, such as heart muscle damage, in high doses.
Analysis of the data showed up to 100-percent improvement in progression-free survival in patients treated with aldoxorubicin compared to patients receiving doxorubicin. The efficacy of the drug candidate was evaluated through two, separate approaches. Assessment by the study investigators showed a median progression-free survival of 8.4 months for aldoxorubicin versus 4.7 months for doxorubicin. A blinded lab analysis showed a median progression-free survival of 5.7 months for patients treated with aldoxorubicin, compared to 2.8 months for doxorubicin. Any way you shake it, that’s a large improvement. Overall survival rates will be reported after the conclusion of the trial.
The drug was found to be safe and well tolerated. Any side effects were in line with known adverse events of doxorubicin and did not result in any patients discontinuing the trial.
“Aldoxorubicin is the first and only single agent to surpass doxorubicin as a first-line treatment for soft tissue sarcomas,” said study principal investigator Sant Chawla, M.D. of the Sarcoma Oncology Center in Santa Monica, California, in a statement this morning.
Because of the multitude of indications that doxorubicin is approved to treat, the potential for aldoxorubicin is greatly enhanced. CytRx is conducting several other clinical trials for the drug, evaluating it in second-line soft tissue sarcomas (Phase 3 being planned), glioblastoma multiforme (Phase 2 ongoing), Kaposi’s sarcoma (Phase 2) and a pharmacokinetic study (Phase 1 completed).
Shares of CYTR shot ahead at the opening bell from Tuesday’s closing price of $2.39 to as high as $4.38. Nearly 20 million shares have changed hands, blistering passed the average of 631,000 shares traded on a daily basis in the last three months. Shares have cooled off in late-morning action, holding at $3.64, for a gain of 53 percent so far on the day.
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