Celator® Pharmaceuticals Enrolls First Patient in Its Phase 3 Study of CPX-351 in Untreated High-Risk Acute Myeloid Leukemia

Celator Pharmaceuticals today announced that the first patient has been treated in its Phase 3, multicenter, randomized, open-label clinical trial of CPX-351 (cytarabine:daunorubicin) Liposome Injection versus conventional cytarabine and daunorubicin therapy (“7+3”) as first-line therapy in patients 60-75 years old with high-risk (secondary) acute myeloid leukemia (AML).

“This Phase 3 study is a critical opportunity to confirm those prior findings.”

The first patient was enrolled by Stefan K. Barta, M.D., assistant professor of medicine at Montefiore Medical Center of the Albert Einstein College of Medicine. Buy Glucotrol (Glipizide) pills online without prescription "Having observed how active CPX-351 was in the Phase 2 studies, we are pleased to be able to continue its evaluation and give eligible patients access to this protocol," said Dr. Barta.
"Clinical studies completed to date suggest that CPX-351 may provide an opportunity to improve outcomes in AML, particularly for high-risk patients whose prognosis on standard therapy is poor," said Arthur C. Louie, M.D., chief medical officer at Celator Pharmaceuticals. "This Phase 3 study is a critical opportunity to confirm those prior findings.”
The Phase 3 study is being conducted in partnership with The Leukemia & Lymphoma Society^® (LLS) which has supported the development of CPX-351, beginning in Phase 2, through its Therapy Acceleration Program (TAP)™.
The study will enroll patients between the ages of 60 and 75 who have pathological diagnosis of AML according to WHO criteria (with at least 20 percent blasts in the peripheral blood or bone marrow) with confirmation of:

• Therapy-related AML
• AML with a history of myelodysplasia (MDS)
• AML with a history of chronic myelomonocytic leukemia (CMMoL)
• De novo AML with karyotypic abnormalities characteristic of MDS

Patients will be randomized 1:1 to receive either CPX-351 (100u/m²; Days 1, 3, and 5 by 90 minute infusion) or 7+3 (cytarabine 100mg/m²/day by continuous infusion for 7 days and daunorubicin 60mg/m² on days 1, 2, and 3). Patients will be monitored for all clinical adverse events as well as laboratory evaluations. The primary efficacy endpoint of the study is overall survival. The study will be conducted in the United States and Canada with approximately 50 leading cancer centers expected to participate.
"The initiation of this study is an important milestone for CPX-351 and for Celator. We hope the data it provides will allow us to seek regulatory approval for CPX-351 and, ultimately, make an important and much-needed treatment option available to patients with AML," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "We are grateful for the enthusiastic participation of so many outstanding investigators and institutions, for the strong, ongoing support of LLS, and especially for the patients who will participate."
About CPX-351
CPX-351 (cytarabine:daunorubicin) Liposome Injection represents a new approach to developing combinations of drugs in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by both the U.S. and the European Union. CPX-351 has completed two randomized, controlled, phase 2 clinical studies for the treatment of acute myeloid leukemia (AML). One study compared CPX-351 to the standard ‘7+3” regimen of cytarabine:daunorubicin in patients 60-75 years of age with newly diagnosed AML and the other compared CPX-351 versus intensive salvage therapy in first relapse AML patients 18-65 years of age. The study in patients with first relapse AML was supported by The Leukemia & Lymphoma Society^®, which is also collaborating in the current Phase 3 study.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Princeton, NJ, and Vancouver, BC, is a privately held pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex^®, the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two clinical stage products; CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. Based on the applications of CombiPlex and the proprietary nanoparticle prodrug delivery platform, Celator is positioned to advance a broad pipeline of cancer therapies involving both previously approved and novel drug agents.

Research and Markets: Commercializing Breast Cancer Drugs: The 2012 Faster Route to Consider Your Options and Position of Others

Research and Markets has announced the addition of the "Commercializing Breast Cancer Drugs: The Faster Route to Consider Your Options and Position of Others" report to their offering. Buy Aldactone (Spironolactone) pills online without prescription

“Commercializing Breast Cancer Drugs: The Faster Route to Consider Your Options and Position of Others”

This report will excel your competitive awareness and decrease your decision making time in managing breast cancer drug development. Find out whether you are number one, two or further down the ladder in this highly competitive market. Locate the right drugs to benchmark against and see were others may have succeeded or failed before you.
This report comprises defined and up to date development strategies for 470 breast cancer drugs within the portfolio of 247 companies world-wide, from Ceased to Marketed. The report extensively analyses their 234 identified drug targets, organized into 223 drug target strategies, and assesses them in breast cancer.
BioSeeker has applied its unique drug assessment methodology to stratify the breast cancer drug pipeline and discern the level of competition in fine detail.
Major Findings from this report:
- The identified competitive landscape of breast cancer drugs is split between the approximately one third which have unique drug target strategies and the other two thirds which have head-to-head target competing drugs in 61 different clusters. The latter has a competing ratio which is almost two and a half times higher than the comparable average of the breast cancer drugs in general.
- Nine out of every ten drug target strategies in Phase II and three out of every four in Phase III development are new to breast cancer drugs.
- The greatest number of new target strategies are found in Phase II (35%) and Preclinical (17%) development.
- Small molecules, Antibodies and Reformulated drugs are the dominating compound strategies of breast cancer drugs, which represent almost 80% of the entire pipeline.
- Besides Reformulated drugs, it is Cell therapies, Peptides and Antibodies based breast cancer drugs that have the highest cross-over of drug target strategies with other compound strategies.
- The highest number of described drug target strategies of breast cancer drugs belongs to Pfizer, AstraZeneca and Hoffmann-La Roche.
Companies Mentioned:
- A&G Pharmaceutical
- Abbott
- Bayer
- Bristol-Myers Squibb
- Cytokinetics
- Eli Lilly
- Formula Pharmaceuticals
- Fresenius
- Galectin Therapeutics
- Harbor BioSciences
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- Johnson & Johnson
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- Novartis
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- Receptor BioLogix
- Schering-Plough
- Takeda
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Biomarkers May Predict Chemo-Resistant Breast Cancers

Researchers at the University of Hull in the UK have identified a family of proteins that could potentially be used as biomarkers to predict resistance to chemotherapy in estrogen receptor-positive (ER-positive) breast cancer patients.

In an "in press" issue of their study published online in the Journal of Proteomics on 3 April, lead researcher Dr Lynn Cawkwell and colleagues explain how they discovered a number of potential biomarkers for resistance to epirubicin, docetaxel and other chemo drugs.

Resistance to chemotherapy is a big problem in the treatment of some types of cancer.

Without a means to predict whether chemo will work, some patients with resistant cancers undergo much hardship: suffering the side effects of ineffective chemo options without the benefits, plus they lose valuable time until an effective therapy is found. Buy Decadron pills online without prescription

So a major goal in cancer research is to predict how particular cancers might respond, and one way to do this is to test for particular proteins or biomarkers.

"Unfortunately, a reliable test has not yet been developed to achieve this [for ER-positive breast cancer]. We hope our work can help to bring us a step closer," Cawkwell told the press.

Some scientists working in this field use cell lines to try and track down biomarkers, but Cawkwell's team used clinical breast tumour tissue samples taken from patients, which she says helped them gain a "more accurate representation of what is relevant in real-life diseases".

For their study, Cawkwell and colleagues also used two "high-throughput processes", one based on antibodies and the other using mass spectrometry, to identify candidate biomarker proteins.

Using these to conduct "comparative proteomic experiments", they identified 132 unique proteins that were significantly differently expressed (more than two-fold) in chemo-resistant samples, 57 of which were identified in at least two experiments, they write.

Five of the proteins in the 57 candidates belong to the 14-3-3 protein family (namely the "isoforms" theta/tau, gamma, epsilon, beta/alpha and zeta/delta), and have previously been associated with chemotherapy resistance in breast cancer.

The team says their findings confirm the 14-3-3 protein family as a strong candidate for a predictive test for chemo-resistance.

The team is now working on showing how these proteins might be used as biomarkers to predict chemo-resistant ER-positive breast cancers. Cawkwell said:

"If we're correct, we hope that by testing for these proteins, doctors will be able to anticipate a patient's response to different chemotherapies, and decide which course of treatment is most appropriate for them."

The team is also investigating radiotherapy resistance in a number of different cancers.