Celator® Pharmaceuticals Presents Positive Results from R&D Programs

- CombiPlex® combinations incorporating molecularly targeted agents show significant efficacy improvements over conventional targeted agent administration regimens -

Nov 10, 2015, 07:00 ET from Celator Pharmaceuticals, Inc.

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

SOURCE Celator Pharmaceuticals, Inc.



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