New Applications Announced for Proprietary CombiPlex Platform Geared Towards Molecularly Targeted Therapies•
CPX-351 to be Explored in Additional Patient Populations, Including New Acute Myeloid Leukemia (AML) Subsets and Other Hematologic Malignancies
"We are very excited to announce that we are broadening the application of the CombiPlex platform and expect to advance the technology to include molecularly targeted therapies in 2015," said
At our Analyst Day program, members of the Celator management team and invited speakers will provide reviews of the company's technology platform and development programs, with an in-depth focus on CPX-351. CPX-351 is a 5:1 synergistic ratio of cytarabine:daunorubicin, co-encapsulated in a nano-scale liposome, based on Celator's CombiPlex technology platform. The CombiPlex approach allows patients elevated exposure to synergistic drug ratios with selective delivery to tumor cells for a prolonged period of time. Celator is currently enrolling patients in a Phase 3 study comparing CPX-351 versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (secondary) AML.
CombiPlex Technology Platform
The Company announced plans to advance the CombiPlex platform and widen its application to include molecularly targeted therapies. Data from the new applications are expected by the third quarter of 2015. Areas of investigation include:
• Combinations targeting signaling pathways associated with major cancer indications: • Inhibitors of PI3K/AKT/mTOR pathway in combination with• Inhibitors of Ras/Raf/MEK/ERK pathway• Combinations of existing chemotherapeutics with molecularly targeted agents: • Active cytotoxics such as taxanes in combination with• Cellular response modulators that control apoptosis• Combinations of epigenetic modulators: • Histone deacetylase inhibitors in combination with• Hypomethylating agents
"We believe the new areas of investigation for CombiPlex will establish proof of principle to support potential research and development collaborations, as well as generate promising new product candidates for internal development," stated
• The Phase 3 study has surpassed 80% of its planned enrollment of 300 patients. Enrollment is expected to be completed in the fourth quarter of 2014.• Remission rate data, a secondary endpoint, is on track for the second quarter of 2015.• Overall survival data, the primary endpoint, is expected in the first quarter of 2016.• Parallel development in other AML patient populations and other hematologic malignancies is underway: • Ongoing Phase 2 study in high-risk myelodysplastic syndromes (MDS) and AML patients at increased risk of treatment-related mortality at
A live webcast will be available on the investor section of Celator's website at www.celatorpharma.com. An archived replay of the webcast will be available on the website for 30 days after the event.
For more information, please visit the company'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. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our pre-clinical and clinical research and development programs, future results, working capital requirements, 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 initiation and conduct of clinical studies and other research programs, enrollment in clinical studies, availability of data from ongoing clinical studies, the outcome of other research programs, the potential efficacy and therapeutic potential of our drug candidates, our prospects for long-term growth, our ability to raise capital, 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