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Celator® Pharmaceuticals and the Leukemia & Lymphoma Society® Announce Positive Data from Phase 2b Study of CPX-351 at the American Society of Hematology Annual Meeting

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SAN DIEGO & WHITE PLAINS, N.Y.--(BUSINESS WIRE)--

Celator Pharmaceuticals, a privately held company developing advanced therapies to treat cancer, and The Leukemia & Lymphoma Society (LLS) today announced positive clinical data in first relapse patients with acute myeloid leukemia (AML) treated with CPX-351 (Cytarabine:Daunorubicin) Liposome Injection. The findings of a randomized Phase 2b clinical study showed a statistically significant benefit in overall survival favoring CPX-351 in patients who had an unfavorable risk profile as assessed by the European Prognostic Index (EPI). In addition, positive trends were seen in overall patient survival, as well as complete remission rates, in patients treated with CPX-351 compared to salvage regimens. The clinical findings were presented this morning from the podium at the 53rd American Society of Hematology (ASH) Annual Meeting being held in San Diego, California (ASH Abstract #254).

The randomized, open-label Phase 2b study treated 125 patients between the ages of 18 and 65 with first relapse AML at 35 sites in the United States, Canada, France and Poland. Patients were stratified using the European Prognostic Index (EPI) and following a 2:1 randomization, 81 patients received CPX-351 and 44 in the control arm received a salvage regimen of the investigators' choice. The study was supported through a partnership between Celator and LLS.

According to data presented by Jorge E. Cortes, M.D., study principal investigator and Chair, CML and AML Sections, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, median overall survival (OS) was 8.5 months in CPX-351-treated patients versus 6.3 months in control patients. In addition, a 33% relative improvement in 1-year survival was observed in patients treated with CPX-351 (36% versus 27%). Complete remission rates (CR + CRi) were 51% in patients receiving CPX-351 vs. 41% in the control arm. A statistically significant difference was seen in OS in patients with unfavorable EPI scores (n=56 vs. 29 respectively): 6.6 months when treated with CPX-351 compared to 4.2 months in the control group (Hazard ratio = 0.55, p=0.02).

Treatment with CPX-351 was associated with well-characterized and manageable adverse events that were generally comparable to salvage therapy. As expected, longer myelosuppression led to increased febrile neutropenia and infections.

“The findings presented at ASH demonstrate that CPX-351, through the targeted delivery of a consistent and synergistic ratio of cytarabine and daunorubicin, results in improved clinical outcomes compared to standard salvage therapy,” stated Dr Cortes. “Enhancing the clinical benefit of the two most active drugs we have against AML gives us the potential to take an important step forward in AML therapy.”

Summary of Clinical Findings


        CPX-351 (n= 81)       Salvage (n= 44)
Remission Rate (CR+CRi) 51% 41%
90-Day Mortality 19% 30%
Median Event-Free Survival 4.0 months 1.4 months
Median Overall Survival 8.5 months 6.3 months
 

Scott Jackson, chief executive officer of Celator Pharmaceuticals, commented, “This is the first public disclosure of our clinical results in first relapse AML, and we are pleased to see that these positive data further build on promising findings reported at last year's ASH meeting, which showed improvements in survival and remission rates for CPX-351 in patients who were newly diagnosed with AML. We believe the preponderance of positive Phase 2 data in both newly diagnosed and first relapse AML patients increases the likelihood of success in pivotal testing and will help us further accelerate the program toward registration.”

“We are very pleased to have partnered with Celator to support this study,” said Louis J. DeGennaro, Ph.D., Chief Mission Officer of LLS. “By paving the way for Phase 3 registration trials, these results fulfill the goal of our Therapy Acceleration Program (TAP) to advance investigational therapies with high prospects for providing near-term benefit to patients with blood cancers.”

Additional CPX-351 presentations at the American Society of Hematology Annual Meeting:

Significance of Prior HSCT on the Outcome of Salvage Therapy with CPX-351 or Conventional Chemotherapy Among First Relapse AML Patients

Abstract # 2619, Session Name: 615. Acute Myeloid Leukemia - Therapy, excluding Transplantation: Poster II
Presentation Time/Location: Sunday, December 11, 2011, 6:00 PM - 8:00 PM, Hall GH
 

A Novel Sequential Treatment Utilizing CPX-351 As Salvage Chemotherapy Followed by a Reduced Intensity Conditioning Allogeneic Stem-Cell Transplantation for Patients with Refractory Leukemia

Abstract # 3030, Session: 721. Clinical Allogeneic Transplantation - Conditioning Regimens, Engraftment and Acute Transplant Toxicities: Acute Transplant Toxicities: Poster II
Presentation Time/Location: Sunday, December 11, 2011, 6:00 PM - 8:00 PM, Hall GH
 

About CPX-351

CPX-351 (Cytarabine:Daunorubicin) Liposome Injection represents a new approach to developing combinations of drugs in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by the U.S. Food & Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML) and was issued a positive opinion on the application for orphan drug designation for the treatment for acute myeloid leukemia by the European Medicines Agency's Committee for Orphan Medicinal Products.

CPX-351 is currently in phase 2 clinical development for the treatment of AML. Celator has completed a successful randomized, phase 2b study comparing CPX-351 to the standard "7+3" regimen of cytarabine:daunorubicin in patients 60-75 years of age with newly diagnosed AML and also has completed a successful randomized, phase 2b study of CPX-351 versus intensive salvage therapy in patients 18-65 years of age with AML in first relapse.

About Celator Pharmaceuticals, Inc.

Celator Pharmaceuticals, Inc., with locations in Princeton, NJ, and Vancouver, BC, is a privately held pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two Phase 2 products; CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage compound, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. Based on the applications of CombiPlex and the proprietary nanoparticle prodrug delivery platform, Celator is positioned to advance a broad pipeline of cancer therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.lls.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET. www.lls.org.

Investors:
Kathy Galante
Burns McClellan
212-213-0006
kgalante@burnsmc.com
or
Media:
Mike Beyer
Sam Brown, Inc.
773-463-4211
beyer@sambrown.com
or
LLS:
Andrea Greif
914-821-8958
andrea.greif@lls.org

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