Celator(R) Pharmaceuticals Announces Participation in Cardiff University Clinical Trial in Adults with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (AML19)January 11, 2016
EWING, N.J., Jan. 11, 2016 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) today announced that CPX-351 (also known as VYXEOS™) has been selected for participation in a Cardiff University-sponsored clinical trial in adult patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
"This study is designed to use a risk-based approach to treat younger patients with AML," said Professor Nigel Russell, Centre for Clinical Haematology, Nottingham University Hospital, the trial's chief investigator. "CPX-351 has demonstrated encouraging activity in high-risk patients. We are excited to study the product in those patients with the highest risk disease."
Some of the anticipated findings from the trial related to CPX-351:
1. Evaluating CPX-351 in younger patients ( < 60 years of age) in a front line setting
2. For poor risk patients, to compare CPX-351 versus FLAG-Ida
3. In patients who fail following FLAG-Ida (two courses) to evaluate a combination of CPX-351 and fludarabine
4. Evaluating the clinical activity of CPX-351 in patients following treatment with an immunoconjugate
5. Evaluating the relevance of detecting minimal residual disease using one of two methods (molecular and immunophenotypic)
6. Health resource utilization
Clinical trials with CPX-351 have shown improved efficacy and reduced early mortality in the majority of patients studied directly supporting evaluating CPX-351 in these patient populations.
"We are pleased that Professor Russell and the trial sponsors chose to study CPX-351 in these patient populations," said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. "As we await overall survival data from our CPX-351 Phase 3 trial in patients with high-risk AML, we believe there is significant potential for CPX-351 in other AML populations as well as other blood cancers such as high-risk MDS, and we believe it important to continue to evaluate these opportunities."
About the AML 19 clinical trial
The trial is open to all patients aged 18 to 60 years, and also to patients aged 60 years or over for whom intensive therapy is considered appropriate. In total, across all arms of the study, approximately 3,000 patients are expected to be recruited. The clinical trial has started enrolling patients.
Patients with known adverse cytogenetics will be randomized to receive either FLAG-Ida (fludarabine/cytarabine/G-CSF and idarubicin) or CPX-351 (cytarabine:daunorubicin) liposome injection as induction. Non-adverse cytogenetic patients will be randomized to compare two courses of FLAG-Ida with DA (daunorubicin/cytarabine) chemotherapy each in combination with one of two doses of the immunoconjugate Mylotarg® (gemtuzumab ozogamicin).
After one course of treatment, patients who are at high risk of relapse based on the AML Risk Score, or who are deemed refractory ( < 50% reduction in blast percentage, and resistant disease) will be eligible to enter a randomized study of FLAG-Ida compared to CPX-351, with the aim of allowing patients to proceed to allogeneic transplant.
Patients who are not in remission after two courses of FLAG-Ida or in relapse within 6 months after FLAG-Ida, are eligible to receive CPX-351 in combination with fludarabine, for induction and consolidation.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a clinical stage biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator's proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensure its exposure to the tumor. Celator's pipeline includes lead product, VYXEOS™ (formerly CPX-351), a liposomal formulation of cytarabine:daunorubicin being studied for the treatment of acute myeloid leukemia; CPX-1, a liposomal formulation of irinotecan:floxuridine being studied for the treatment of colorectal cancer; and a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation, being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. The company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies. The company is seeking research and development collaborations, applying its proprietary technologies, with other biotechnology/pharmaceutical companies.
For more information, please visit Celator's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the safety, potential efficacy and therapeutic potential of VYXEOS™ (formerly CPX-351), our expectations regarding our research and development programs and advancing our CombiPlex platform and the potential to establish research and development collaborations applying our proprietary technologies with other biotechnology/pharmaceutical companies. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our development programs, future results, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of clinical studies, whether clinical study results obtained to date will be predictive of future results, whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS™ and other matters that could affect the commercial potential of our drug candidates. Celator undertakes no obligation to update or revise any forward-looking statements. Celator undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Celator's Form 10-K for the year ended December 31, 2014, subsequent reports on Form 10-Q and 8-K, and other filings by the company with the U.S. Securities and Exchange Commission.
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