CPX-351 demonstrates a 43.2% relative improvement in induction response rate
Data on overall survival, the primary endpoint, are expected in the first quarter of 2016. However, induction response rate is a key secondary endpoint in the study and has been an important surrogate of overall survival and clinical benefit in this patient population. These data validate the induction response rates observed in the Phase 2 study, which was associated with a marked improvement in overall survival.
"The results are encouraging because this is the third randomized study in
which CPX-351 outperformed the control arm of cytarabine plus an
anthracycline in overall response rate," said Jeffrey Lancet, M.D., Senior
Member and Chief of the Leukemia/Myelodysplasia Program at
The randomized, controlled, Phase 3 study evaluated 309 patients, aged 60-75
years, from 39 clinical centers in the U.S. and
"We are very pleased with the induction response rate results. This is one
of the largest trials conducted in this specific patient population, and
based on the improvement seen with CPX-351, we are optimistic about the
opportunity for CPX-351 to improve overall survival in this patient
population," said
Data on the primary endpoint of the study, overall survival, are expected in the first quarter of 2016.
Additional information regarding the study is available at http://clinicaltrials.gov/show/NCT01696084.
Conference Call Information:
Celator will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss the induction response results from its Phase 3 study. To participate in the conference call, please dial 877-303-6316 (domestic) or 650-521-5176 (international) and refer to conference ID 73362390. The live webcast of the call can be accessed in the Investors section of Celator's website at www.celatorpharma.com. An archived webcast will be available on Celator's website beginning approximately two hours after the event.
About CPX-351
CPX-351 (cytarabine:daunorubicin) Liposome for 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
About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that there will be 20,830 new cases of AML and 10,460 deaths from AML in the U.S. in 2015. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About
For more information, please visit Celator's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
Forward-Looking Statements:
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 potential safety, tolerability, efficacy
and therapeutic and commercial potential of CPX-351, our expectations
regarding our development plans for CPX-351 and our other drug candidates,
the availability of data from clinical studies, and whether final results of
clinical studies will be supportive of regulatory approvals required to
market licensed products. Forward-looking statements in this release involve
substantial risks and uncertainties that could cause our clinical
development programs, future results, performance 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, availability of
data from ongoing clinical studies, whether clinical study results for
CPX-351 obtained to date will be predictive of future results, expectations
for regulatory approvals, and other matters that could affect the
availability or commercial potential of our drug candidates. 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
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