Nanotechnology Now

Our NanoNews Digest Sponsors





Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > Celator(R) Pharmaceuticals Announces Positive Data From Phase 2 Study of CPX-351 in Acute Myeloid Leukemia

Abstract:
Celator Pharmaceuticals, Inc. today announced positive results from its Phase 2 study of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus conventional cytarabine and daunorubicin (the "7+3" regimen) in patients, 60-75 years of age, with untreated acute myeloid leukemia (AML).

Celator(R) Pharmaceuticals Announces Positive Data From Phase 2 Study of CPX-351 in Acute Myeloid Leukemia

Princeton, NJ | Posted on May 3rd, 2010

The primary endpoint of the study, the rate of patients achieving a complete remission with CPX-351 compared to "7+3," achieved statistical significance. In addition, there was a reduction in the 30-day and 60-day mortality with CPX-351 versus the "7+3" regimen.

The multicenter, randomized, open-label trial enrolled a total of 126 patients between November 2008 and October 2009. Patient follow-up is ongoing. Results from this study will be submitted to a major medical conference in 2010.

"The control arm, cytarabine plus daunorubicin, has been the standard of care for treating patients with AML for more than 30 years," said Arthur Louie, MD, chief medical officer at Celator Pharmaceuticals, Inc. "To demonstrate an improvement in complete remission rate coupled with an improvement in early death rate is very encouraging. We expect to have additional information on the secondary endpoints later this year."

The primary endpoint of the study was a comparison of complete remission rates - which includes complete remissions (CR) and complete remissions with an incomplete recovery, to a specified level, of neutrophils and/or platelets (CRi). Both CR and CRi result in patients becoming leukemia-free. The secondary endpoints of the study include duration of complete remission, event-free survival, 12-month survival, and the rate of patients going on to receive stem cell transplantation. The full safety analysis will include 30-, 60-, and 90-day mortality rates.

"We are very excited that CPX-351 may offer patients a new, more effective treatment option," said Scott Jackson, chief executive officer at Celator Pharmaceuticals, Inc. "These data suggest that our approach with CPX-351 significantly improves clinical benefit compared to conventional administration of cytarabine and daunorubicin. We will meet with the FDA later this year to discuss our results and plans for a Phase 3 study of CPX-351 in AML."

####

About Celator Pharmaceuticals
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 phase 2 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 compound, 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. For more information, please visit the company's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.

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 the U.S. Food & Drug Administration (FDA) for the treatment of AML. Celator is currently conducting a second randomized phase 2 study of CPX-351 versus intensive salvage therapy in patients up to 65 years of age with AML in first relapse. Enrollment is expected to be completed in 2010. This study is supported by The Leukemia & Lymphoma Society.

For more information, please click here

Contacts:
Celator Pharmaceuticals, Inc.
303B College Road East
Princeton, NJ 08540
USA
Telephone: (609) 243-0123
Fax: (609) 243-0202

Copyright © Celator Pharmaceuticals

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Draw out of the predicted interatomic force August 30th, 2015

Iranian Scientists Use Artemisia Annua Plant to Produce Breast Cancer Drugs August 29th, 2015

Small but heading for the big time: Nanobiotix half year results for the six months ended 30 June 2015, in line with expectations: Major clinical achievements and corporate developments August 28th, 2015

A new technique to make drugs more soluble August 28th, 2015

Possible Futures

Sediment dwelling creatures at risk from nanoparticles in common household products August 13th, 2015

Harris & Harris Group Reports Financial Statements as of June 30, 2015, and Announces a Stock Repurchase Program August 10th, 2015

Molecular trick alters rules of attraction for non-magnetic metals August 5th, 2015

Global Carbon Nanotubes Industry 2015: Acute Market Reports August 4th, 2015

Nanomedicine

Iranian Scientists Use Artemisia Annua Plant to Produce Breast Cancer Drugs August 29th, 2015

Small but heading for the big time: Nanobiotix half year results for the six months ended 30 June 2015, in line with expectations: Major clinical achievements and corporate developments August 28th, 2015

A new technique to make drugs more soluble August 28th, 2015

These microscopic fish are 3-D-printed to do more than swim: Researchers demonstrate a novel method to build microscopic robots with complex shapes and functionalities August 26th, 2015

Announcements

Draw out of the predicted interatomic force August 30th, 2015

Iranian Scientists Use Artemisia Annua Plant to Produce Breast Cancer Drugs August 29th, 2015

Small but heading for the big time: Nanobiotix half year results for the six months ended 30 June 2015, in line with expectations: Major clinical achievements and corporate developments August 28th, 2015

A new technique to make drugs more soluble August 28th, 2015

Nanobiotechnology

Small but heading for the big time: Nanobiotix half year results for the six months ended 30 June 2015, in line with expectations: Major clinical achievements and corporate developments August 28th, 2015

Nanotechnology that will impact the Security & Defense sectors to be discussed at NanoSD2015 conference August 25th, 2015

Louisiana Tech University researchers discover synthesis of a new nanomaterial: Interdisciplinary team creates biocomposite for first time using physiological conditions August 24th, 2015

How UEA research could help build computers from DNA August 19th, 2015

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







Car Brands
Buy website traffic