EWING, N.J., Aug. 11, 2015 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today reported business highlights and financial results for the second quarter ended June 30, 2015.
"We capped off a very busy second quarter by reporting positive induction response rate data in the Phase 3 study of VYXEOS (CPX-351) in patients with high-risk (e.g. secondary) acute myeloid leukemia (AML)," said Scott Jackson, chief executive officer of the Company. "We believe response is an important surrogate for overall survival and clinical benefit in this patient population. We intend to build on that momentum as we advance our broader clinical development program, report data on CombiPlex® technology platform studies, and increase pre-commercial activities." Mr. Jackson continued, "Data on overall survival are expected in the first quarter of 2016, with an NDA submission planned for the third quarter of 2016. If approved, VYXEOS will be well-positioned to become the foundation of care for high-risk AML patients."
Second Quarter 2015 and Recent Highlights:
- The Company reported positive induction response rate results from the Phase 3 study of CPX-351 in patients with high-risk (e.g. secondary) AML.
- The FDA granted approval of the brand name VYXEOS for CPX-351.
- Enrollment was completed in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 on cardiac repolarization in adult patients with acute hematologic malignancies, including AML, acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS).
- As part of the Company's existing $5 million Phase 3 partnership with the Leukemia & Lymphoma Society®, Celator achieved a milestone payment of $900,000 based on positive induction response rate data from the Phase 3 study, thereby bringing the total amount received to date to $4.9 million.
- At the Company's Analyst and Investor Day, management presented an overview of the company's growth strategy which included VYXEOS and our proprietary technology platform, CombiPlex. Key thought leaders, Gail Roboz, M.D. and Bruno C. Medeiros, M.D., discussed AML and VYXEOS. In addition, Anthony Tolcher, M.D., presented on the challenges and opportunities of combining molecularly targeted agents which may be addressed by CombiPlex. The presentations are on the Company's website at: http://www.celatorpharma.com/#!events-and-presentations/c1iw5
- The Company announced that enrollment had commenced in an investigator-initiated Phase 2 clinical study, at MD Anderson Cancer Center, evaluating CPX-351 as a treatment for patients with newly diagnosed AML at high risk for induction treatment mortality.
- Based on encouraging safety and efficacy results, a patient cohort was expanded in an investigator-initiated study, being conducted at both the Fred Hutchinson Cancer Research Center and Stanford University, evaluating CPX-351 in patients with either untreated MDS or AML at high-risk of treatment-related mortality.
- Data were presented describing the effects of combining CPX-351 with traditional chemotherapy and novel molecularly targeted agents intended for use in treating AML and other blood cancers at the American Association for Cancer Research (AACR) Annual Meeting.
Financial Highlights:
- Cash Position: Cash and cash equivalents as of June 30, 2015 were $28.5 million, compared to $32.4 million as of December 31, 2014. The decrease of $3.9 million was primarily due to $9.0 million of net cash used in operating activities, partially offset by $5.0 million in proceeds from the final draw down of the Hercules Technology Growth Capital loan. Cash and cash equivalents as of March 31, 2015 were $32.9 million. Management believes that the cash and cash equivalents at June 30, 2015 will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2016.
- R&D Expenses: Research and development expenses were $3.5 million and $6.2 million for the three and six months ended June 30, 2015, as compared to $2.9 million and $5.9 million for the same periods in 2014.
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