EWING, N.J., Nov. 10, 2015 /PRNewswire/ -- Celator
Pharmaceuticals, Inc. (Nasdaq: CPXX) announced the presentation of
positive results from its CombiPlex® technology platform applied to
drug combinations incorporating molecularly targeted agents (MTAs)
at the AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics.
CombiPlex is Celator's proprietary technology that uses
nano-scale drug carriers to ensure the optimal ratio of anticancer
drugs are simultaneously delivered and selectively exposed to tumor
cells for prolonged periods of time while reducing drug exposure
and toxicity to normal tissues. The technology addresses
difficulties often experienced with conventional MTA combination
regimens, where significant toxicities and/or incomplete target
inhibition can lead to sub-optimal patient outcomes.
Pre-clinical data presented at the conference demonstrated the
broad applicability of Celator's hydrophobic prodrug nanoparticle
(HPN) delivery technology to MTAs from diverse classes, including
inhibitors of MEK, Akt, HSP90, B-Raf and FGFR. In all cases,
Celator's proprietary HPN delivery eliminated the early drug
distribution phase observed for conventional formulations of these
agents, which historically has been associated with significant
exposure and toxicity to normal tissues. In fact, HPN
co-formulated combinations of docetaxel plus the HSP90 inhibitor
AUY922, and the MEK:Akt inhibitor combination of selumetinib plus
ipatasertib, could be administered at much higher drug exposure
with maintained improvements in safety while also resulting in
increased efficacy.
The largest improvements were observed in tumor models known to
be more resistant to conventional dosing forms of the two
combinations. Optimal efficacy was achieved at drug ratios of
1:2 and 2:1, respectively. In the case of docetaxel:AUY922,
the conventional formulation provided negligible tumor growth delay
at the maximum tolerated dose (MTD) in the OVCAR-8 human ovarian
xenograft model with tumors reaching 1 gram in size in
approximately 25 days. In contrast, dosing with Celator's
proprietary HPN formulation at MTD, tumors grew to only half that
size after 50 days demonstrating potent tumor growth
inhibition.
"As an oncologist who has personally experienced the challenges
with combining conventional formulations of molecularly targeted
agents in a clinical setting, I am very encouraged by the results
Celator has generated using its CombiPlex technology," said Dr.
Tony Tolcher, director of clinical
research at South Texas Accelerated Research Therapeutics. "This
approach could provide an important breakthrough in our ability to
optimize the therapeutic index and patient outcomes for many
molecularly targeted agent combinations."
Once HPN formulation conditions were optimized for these initial
combinations, the approach was readily extended to the B-Raf
inhibitor GDC0879 and the FGFR inhibitor LY2874455 and both were
successfully co-formulated with the MEK inhibitor selumetinib
resulting in coordinated drug exposure in the plasma. In
addition, the drug components could be "mixed and matched," and
this versatility was then taken one step further by generating a
3-drug combination, co-formulating selumetinib, AUY922 and
docetaxel into a single HPN that exhibited a plasma half-life in
the range of 10 hours in mice with no early distribution phase.
"The CombiPlex technology platform continues to deliver on its
promise to optimize the efficacy of a wide range of anticancer drug
combinations," said Dr. Lawrence
Mayer, president and chief scientific officer at Celator.
"The successful application of this technology to molecularly
targeted agents across a wide range of drug classes makes a
compelling data package that we believe will be instrumental in
attracting R&D collaborations with pharmaceutical
companies."
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.
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 safety, potential efficacy
and therapeutic potential of our CombiPlex technology platform and
HPN delivery technology and formulations, other drug
combinations, the therapeutic potential of our research and
development programs and the potential to establish research and
development collaborations, applying our proprietary technologies
to those of other 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 pre-clinical studies, whether clinical
study results for drug combinations obtained to date will be
predictive of future results, and other matters that could affect
the development and therapeutic potential of our drug candidates,
including the ability to enter into research and development
collaborations with other pharmaceutical
companies. 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.
CONTACTS:
Media:
Mike Beyer
Sam Brown, Inc.
312-961-2502
beyer@sambrown.com
Investors:
Adam Krop
The Trout Group
646-378-2963
akrop@troutgroup.com
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SOURCE Celator Pharmaceuticals, Inc.