Celator Pharmaceuticals Inc (NASDAQ:CPXX) announced that the independent Data and Safety Monitoring Board (DSMB) for the Company’s Phase 3 clinical study of CPX-351 (cytarabine:daunorubicin) Liposome for Injection (now referred to as VYXEOS™) has completed the final pre-planned safety review of all patients and has again recommended the study continue as planned without any modifications.
The Phase 3 study compares VYXEOS versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (e.g. secondary) acute myeloid leukemia (AML). The primary endpoint for the study is overall survival, which the company expects to report in the first quarter of 2016.
“Our confidence in the safety profile of VYXEOS is further strengthened with each positive DSMB recommendation,” said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. “The conduct of the Phase 3 study has gone remarkably well, having achieved each milestone on time or ahead of schedule. This final confirmation of safety for the Phase 3 study is a major step in the development of VYXEOS for patients with poor prognosis AML.”
The Phase 3 study is being conducted in partnership with The Leukemia & Lymphoma Society® (LLS) through its Therapy Acceleration Program (TAP), which has supported the clinical development of VYXEOS beginning in Phase 2.
Additional Information about the Phase 3 Study
The study (Protocol NCT01696084) enrolled 309 patients between the ages of 60 and 75 who have pathological diagnosis of high-risk AML according to WHO criteria with confirmation of:
- Therapy-related AML,
- AML with a history of myelodysplasia (MDS),
- AML with a history of chronic myelomonocytic leukemia (CMMoL), or
- De novo AML with karyotypic abnormalities characteristic of MDS.
Patients were randomized 1:1 to receive either VYXEOS (100u/m2; days 1, 3, and 5 by 90 minute infusion) or 7+3 (cytarabine 100mg/m2/day by continuous infusion for 7 days and daunorubicin 60mg/m2 on days 1, 2, and 3). Patients are monitored for all clinical adverse events as well as laboratory evaluations. The study is being conducted in the United States and Canada. (Original Source)
Shares of Celator Pharmaceuticals closed last Friday at $1.77. CPXX has a 1-year high of $3.53 and a 1-year low of $1.58. The stock’s 50-day moving average is $2.05 and its 200-day moving average is $2.20.
On the ratings front, Celator Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on September 24, Roth Capital analyst Joseph Pantginis maintained a Buy rating on CPXX, with a price target of $18, which implies an upside of 916.9% from current levels. Separately, on August 12, FBR’s Thomas Yip maintained a Buy rating on the stock and has a price target of $6.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Thomas Yip have a total average return of -4.9% and -10.0% respectively. Pantginis has a success rate of 33.7% and is ranked #3727 out of 3788 analysts, while Yip has a success rate of 25.9% and is ranked #3541.
Celator Pharmaceuticals Inc is a pharmaceutical company.