November 30, 2016
By Alex Keown, BioSpace.com Breaking News Staff
LOS ANGELES – After updating data results from a Phase III trial evaluating aldoxorubicin in patients with relapsed or refractory soft tissue sarcomas, California-based CytRx (CYTR) plans to seek regulatory approval sometime next year for a drug once thought dead.
On Tuesday, CytRx said updated data testing aldoxorubicin against investigator’s choice of treatment demonstrated a statistically significant improvement in progression-free survival (PFS) between in 246 patients with leiomyosarcoma and liposarcoma. The trial included a total of 433 patients. Leiomyosarcoma and liposarcoma are the two most common types of STS and accounted for 57 percent of the patients enrolled in the trial, CytRx said in a statement.
Daniel Levitt, chief medical officer of CytRx, said the updated data indicates patients treated with aldoxorubicin exhibited “significantly longer PFS than patients treated with both FDA-approved and commonly used therapies in the second-line setting.”
“These results are important because they demonstrate that treatment with aldoxorubicin can extend the time to progression in a clinically meaningful way. The trial design used was more stringent than any prior clinical trial in STS as it compared aldoxorubicin to real world alternatives… Unlike other clinical trials for relapsed or refractory STS which used either dacarbazine or placebo as the control, this study was biased in favor of choosing the best therapy for the patients, a truly unique study design,” Sant Chawla, director of the Sarcoma Oncology Center in Santa Monica and principal investigator for the Phase III trial, said in a statement.
The most recent data stands in contrast to data the company released in July that showed aldoxorubicin failed to meet its endpoints. The trial had been placed on a partial clinical hold in 2014 and the company said data analysis released in July “did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase III study after the hold was resolved and enrollment resumed.”
“This resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation. CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints,” the company said in July.
As CytRx prepares to file its New Drug Application, The Street’s Adam Feuerstein speculated that the company will drag its feet as the U.S. Food and Drug Administration “isn’t likely to ignore the 187 sarcoma patients CytRx deleted just to claim victory from a failed study.” Feuerstein was highly critical of the company, saying the drawn out filing would be sparked primarily by Chairman and Chief Executive Officer Steve Kriegsman’s desire to pad his bank account. The longer the delay in filing and awaiting a decision, which Feuerstein said is likely to be a rejection, the more money Kriegsman stands to earn —all while shareholders stand to lose out. In 2015, Kriegsman earned total compensation of about $2.6 million, Feuerstein said.
Shares of CytRx stock are down more than 8 percent this morning. The stock has not recovered from the sharp decline it took in July following the initial failure of aldoxorubicin. In all, the stock is down about 79 percent for 2016 and down 76 percent over the past five years, Feuerstein said. BioSpace reached out to David Haen, CytRx’s vice president of business development and investor relations for comment regarding Feuerstein’s article. We will update when we hear back.