PRINCETON, N.J., June 4 /PRNewswire/ -- Celator Pharmaceuticals announced positive safety and efficacy results from its Phase I study of CPX-1 (Irinotecan HCI:Floxuridine), Liposome Injection in patients with heavily pre-treated, advanced solid tumors. Results were presented yesterday in a poster presentation at the American Society of Clinical Oncology (ASCO) meeting in Chicago.
Among a total of 33 patients with different types of cancer who were treated in the dose-escalating study, 73% showed clinical benefit including either partial regression or stable disease. In ten patients delay of disease progression was greater than six months. Among a subset of 15 patients with colorectal cancer, median duration of progression-free survival was 5.3 months. Of these patients, 80% received CPX-1 as a third, fourth or fifth line treatment, and 66% had prior treatment with irinotecan.
"These results provide us with the essential dosing and safety data we need to advance CPX-1 through Phase 2 clinical trials and toward commercialization. Even more importantly, this study also produced very encouraging results related to clinical benefit, which is uncommon in a Phase 1 study," said Andrew Janoff, Ph.D., CEO of Celator.
CPX-1 is a combination therapy including irinotecan HCI and floxuridine, two approved and well known drug agents to treat cancer. The formulation of CPX-1 was developed based on ratiometric dosing using Celator's CombiPlex(TM) technology platform, a proprietary technology that identifies the optimal ratio of drugs to use in combination therapies and then incorporates an advanced nanoparticle delivery system to maintain those optimal ratios when drugs are administered and metabolized in patients. Pending regulatory approval, CPX-1 would be the first commercially-available combination therapy based on Celator's ratiometric dosing drug development platform.
"What we found in this study is that our ratiometric dosing formulation of irinotecan and floxuridine achieved the targeted 1:1 molar ratio that provided synergistic benefits to all patients including those who had been treated previously with irinotecan. Based on these findings, Celator is moving forward with a Phase 2 study for CPX-1 that includes treatment of irinotecan- naïve patients as well as patients who are resistant or refractory to irinotecan," said Arthur Louie, M.D., Celator's chief medical officer.
The ongoing phase 2 study for CPX-1 involves patients with colorectal cancer who will be treated at sites in the U.S. and Canada. For information, visit: www.clinicaltrials.gov/ct/show/NCT00361842?order=1.
ABOUT CELATOR
Celator Pharmaceuticals, Inc., formerly Celator Technologies, Inc., is a privately held biopharmaceutical company working to develop new and more effective therapies to treat cancer. CombiPlex, the company's drug ratio technology platform, represents a revolutionary new approach to the development of combination therapies based on the optimal ratio of drug agents to target cancer cells effectively. The company pipeline includes: CPX-1, currently in Phase 2 trials as a treatment option for colorectal cancer; CPX-351, currently in Phase 1 trials as a treatment for leukemia (for information visit www.clinicaltrials.gov/ct/show/NCT00389428?order=2); CPX 571, now positioned to advance to Phase 1 trials and targeting small cell lung cancer; and multiple early stage pre-clinical development programs. Based on the applications of CombiPlex, Celator is positioned to advance a broad pipeline of combination therapies involving both previously approved and novel drug agents.
Celator PharmaceuticalsCONTACT: Paul Hendley of Celator Pharmaceuticals, +1-212-253-8881,phendley@berrypr.com
