WHITE PLAINS, N.Y., March 14, 2016 /PRNewswire-USNewswire/ — An investigational therapy supported by The Leukemia & Lymphoma Society (LLS) performed significantly much better compared to the standard therapy in a Phase 3 clinical trial for patients along with high-risk (secondary) acute myeloid leukemia (AML), its developer announced today. AML remains the deadliest of all of blood cancers, and there have actually been no Brand-new therapies for nearly 40 years.
LLS funded the Phase 3 clinical trial through its Therapy Acceleration Program® (TAP), which supports promising projects and clinical trials through collaborations along with biotechnology companies. LLS began partnering along with Celator Pharmaceuticals, Inc. in 2009 to create the therapy, CPX-351 (VYXEOS TM), an innovative formulation of two existing chemotherapy drugs used to manage AML, as quickly as it was still in Phase 2 clinical trials.
“The vision for our innovative Therapy Acceleration Regimen is becoming a truth along with this promising potential therapy for patients along with AML, as we are obtaining closer to addressing this urgent unmet demand for blood cancer patients,” said Louis J. DeGennaro, LLS’s president and CEO. “From the start, LLS recognized the potential of CPX-351, so we are fairly gratified along with the outcomes of this clinical trial, and we are hopeful that this positive news brings us a step closer to delivering much better outcomes for patients along with high-risk (secondary) AML.”
LLS initial launched TAP in 2007, recognizing that therapies were not obtaining to patients fast enough. Through TAP, LLS supports applied research and forges collaborations along with biotechnology companies to advice bridge the gap between discoveries in the laboratory and successful drug development. If CPX-351 receives FDA approval, it would certainly mark the initial time that LLS’s direct investment in a biotechnology firm has actually resulted in assisting to delivering a drug in to the healthiness care arena, a considerable achievement for LLS’s venture philanthropy initiative.
As the world’s largest voluntary agency dedicated to blood cancers, LLS is leading the offensive to modification the paradigm of treatment for patients along with AML, which remains among the many lethal blood cancers. Much more compared to 25 percent of LLS’s budget is dedicated to AML research, and along with the launch of its Beat AML initiative in 2013, LLS is fostering collaboration among researchers at multiple institutions, regulators, pharmaceutical and biotechnology companies, primary healthcare physicians and patients, to much better know the underlying induces of the illness and create Much more efficient therapies to manage patients along with AML.
More concerning the CPX-351 clinical trial
The patients in the Phase 3 trial for CPX-351 were 60 to 75 years of age, newly diagnosed along with AML, which they created as a secondary cancer, either as a result of treatment for or history of a myelodysplastic syndrome (MDS), or others rare forms of myeloid malignancies. Overall, the median age of an AML patient is 67. While those along with AML under the age of 60 have actually much better treatment outcomes, collectively, AML patients across all of risk categories face an especially grim prognosis, as 75-80% of patients die within 5 years. Those patients along with higher risk (secondary) AML have actually a even worse prognosis, thereby accentuating the demand for Brand-new therapy options. The standard of care for patients along with AML has actually not changed in nearly 40 years.
The clinical trial successfully met its primary endpoint, demonstrating a statistically considerable improvement in overall survival as compared to the conventional treatment routine known as 7+3, which entails two chemotherapy drugs, cytarabine and daunorubicin. CPX-351 is a liposomal formulation of cytarabine and daunorubicin, and is made to deliver a Much more perfect ratio of the drugs along with much less toxicity.
The median overall survival for patients treated along with CPX-351 in the multi-site study was 9.56 months compared to 5.95 months for patients receiving 7+3 (HR=0.69, p=0.005). This represents a 31 percent reduction in the risk of death for patients treated along with CPX-351. At 12 months, 41.5% of the patients were alive on the CPX-351 arm compared to 27.6% on the 7+3 arm. At 24 months, 31.1% of the patients were alive on the CPX-351 arm compared to 12.3% on the 7+3 arm.
Thirty-four percent of patients treated along with CPX-351 went on to receive a stem cell transplant compared to 25 percent of patients treated along with 7+3.
Based on these results, Celator expects to file a Brand-new Drug Application (NDA) for CPX-351 along with the U.S. Meals and Drug Administration (FDA) by the end of the 3rd quarter 2016.
Celator will certainly host a conference call and live audio webcast on Tuesday, March 15, 2016 at 8:00am EDT to discuss the outcomes of the Phase 3 trial. To participate in the conference call, please dial 877-303-6316 (domestic) or 650-521-5176 (international) and refer to conference ID 71930208. The live webcast of the call can easily be accessed in the Investors section of Celator’s website at http://ift.tt/1jLhGHR. An archived webcast will certainly be offered on Celator’s website start roughly two hours after the event.
Celator will certainly present the data at the American Society of Clinical Oncology 2016 Annual Meeting in June.
See Celator’s news release for Much more details concerning the trial and the therapy.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world’s largest voluntary healthiness agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and boost the quality of life of patients and their families. LLS funds lifesaving blood cancer research about the world, provides free write-up and support services, and is the voice for all of blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in White Plains, NY, LLS has actually chapters throughout the United States and Canada. To find out more, visit www.LLS.org. Patients need to contact the write-up Resource Focus at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
Contact: Andrea Greif
Tel: (914) 821-8958
Cell: (914) 772-3027
andrea.greif@lls.org
SOURCE The Leukemia & Lymphoma Society
RELATED LINKS
http://www.LLS.org
