(Reuters) - Celator Pharmaceuticals Inc on Monday said its Vyxeos treatment helped older high-risk patients with a deadly form of leukemia live longer than those who received the standard of care regimen in a late stage clinical trial, sending its stock price soaring.
Celator shares jumped to $9 in extended trading from a Nasdaq close at $1.68. The stock has settled back to $7.60.
In the Phase III study of 309 patients with secondary, or high risk, acute myeloid leukemia, those who received Vyxeos, also known as CPX-351, on average lived for 9.6 months after the start of the trial. That compared with 6 months for those who got the standard combination treatment of cytarabine and daunorubicin.
Two years after the start of the trial, 31.1 percent in the Vyxeos group were still alive versus 12.3 for the standard treatment group.
Given the survival advantage, higher response rate and lack of increase in serious toxicity seen with CPX-351 in this trial, “we’ll likely have a new standard of care for treating older patients with secondary AML,” Dr. Jeffrey Lancet, the study’s lead investigator, said in a statement.
Based on the results, the company said it would submit its applications seeking U.S. approval later this year and European approval in the first quarter of 2017.
“These findings confirm that Vyxeos provides the first opportunity we’ve had in decades to extend survival for patients with high-risk AML,” Dr. Gail Roboz, Director of the Leukemia Program at the Weill Medical College of Cornell University in New York said in a statement.
The rate of serious side effects was similar for both groups, the company reported.
Vyxeos contains the same two drugs as the standard of care regimen, but uses a novel formulation and delivery system designed to maintain the desired ratio of the two medicines in circulation until they reach the tumor cell.
AML is a rapidly progressing blood cancer that tends to hit older people. There will be an estimated 20,000 new AML cases and more than 10,400 deaths in the United States this year, according to the American Cancer Society. In patients over 60 years of age, the five-year survival rate is less than 10 percent.
Reporting by Bill Berkrot; Editing by Bernard Orr
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