Celator Pharmaceuticals Inc (NASDAQ:CPXX) announced that a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of VYXEOS™ (CPX-351) on cardiac depolarization/repolarization has concluded and VYXEOS did not prolong the QT/QTc interval.
This study, in adult patients with acute hematologic malignancies, was conducted to support the U.S. Food and Drug Administration (FDA) requirements of a New Drug Application (NDA), which Celator hopes to file for VYXEOS after completing the ongoing Phase 3 clinical study in patients with high risk (secondary) acute myeloid leukemia (AML).
The QT interval represents the amount of time the heart’s electrical system takes to depolarize and repolarize during each heartbeat. Prolongation of the QT interval may increase the risk of cardiac arrhythmias and is a biomarker for Torsade de Pointes, a sometimes fatal form of ventricular tachycardia. An intensive QT study is a specialized clinical trial conducted in a relevant patient population designed to assess whether an investigational medication has the potential to prolong the QT interval.
This open-label, single arm, Phase 2 study measured the effects of VYXEOS on cardiac repolarization during the first induction cycle and correlated electrophysiologic changes, as measured by the QT/QTc interval, with a detailed pharmacokinetic assessment of cytarabine and daunorubicin and their metabolites using exposure response modeling methodology. The study completed enrollment in June 2015. Each patient received a first induction of VYXEOS on days 1, 3 and 5 and, if necessary, a second induction for patients with reduced leukemia burden not yet achieving a disease-free state. Responding patients were eligible for up to four consolidation courses.
Patients with newly diagnosed de novo and newly diagnosed secondary AML, relapsed/refractory AML, and relapsed/refractory acute lymphoblastic leukemia (ALL) were enrolled. Responses were seen in patients with de novo AML, newly diagnosed secondary AML, relapsed AML, and refractory ALL. Adverse events were consistent with those previously reported.
Data from this study has been accepted for poster presentation at the 57th American Society of Hematology (ASH) Annual Meeting. The abstract, titled “CPX-351 ((Cytarabine:Daunorubicin) Liposome Injection, (VYXEOS)) Does Not Prolong QTcF Intervals, Requires No Dose Adjustment for Impaired Renal Function and Induces High Rates of Complete Remission in Acute Myeloid Leukemia,” will be presented on Sunday, December 6, 2015 from 6:00 p.m. to 8:00 p.m. EST.
“We continue to work expeditiously to bring VYXEOS before the FDA as a potential new treatment option for patients with acute hematologic malignancies,” said Scott Jackson, Chief Executive Officer of Celator. “Clinical pharmacology studies are required by the FDA for new drugs in development, so we are pleased to announce this top-line result and expect to report additional information from this study at the ASH Annual Meeting.” (Original Source)
Shares of Celator Pharmaceuticals closed yesterday at $1.72. 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 $2.03 and its 200-day moving average is $2.19.
On the ratings front, Celator 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 represents a potential upside of 946.5% from where the stock is currently trading. 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 -6.1% and -11.4% respectively. Pantginis has a success rate of 33.7% and is ranked #3752 out of 3795 analysts, while Yip has a success rate of 22.2% and is ranked #3587.