Navigation Links
Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351
Date:9/4/2008

CPX-351 awarded orphan designation for the treatment of Acute Myeloid

Leukemia

PRINCETON, N.J., Sept. 4 /PRNewswire/ -- Celator Pharmaceuticals today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for the treatment of Acute Myeloid Leukemia (AML).

Celator is currently preparing to conduct two randomized Phase 2 studies with CPX-351. The first Phase 2 study, in newly diagnosed, elderly patients with AML, is expected to start enrolling patients before the end of 2008. The second study, in AML patients who have relapsed following initial treatment, is projected to start enrolling patients in the first quarter of 2009.

Interim Phase 1 data with CPX-351, where complete remissions were obtained in patients with advanced leukemia, were reported in December 2007. The company submitted additional CPX-351 preclinical and clinical data to this year's American Society of Hematology (ASH) meeting in December and will report Phase 1 results at that time.

CPX-351 is a liposomal formulation of cytarabine and daunorubicin delivered in a 5:1 molar ratio shown to be strongly synergistic in preclinical studies. CPX-351 was developed using Celator's proprietary CombiPlex(R) technology platform.

Orphan drug status is granted to treatments for diseases that affect fewer than 200,000 people in the United States and provides the benefits of market exclusivity for seven years, tax credits, and a waiver of FDA user fees.

"The decision by FDA to grant CPX-351 orphan drug designation reinforces the importance of developing novel products for the treatment of rare diseases and represents another milestone for the company," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "We are committed to developing products that will benefit patients and look forward to initiating enrollment in our CPX-351 Phase 2 program."

About Acute Myeloid Leukemia (AML)

The National Cancer Institute defines AML as a quickly progressing disease in which too many immature white blood cells (not lymphocytes) are found in the blood and bone marrow. In 2008, the American Cancer Society's Cancer Facts and Figures estimates that there will be 13,290 new cases of AML and 8,820 deaths caused by AML.

About Celator

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(R), the company's drug ratio technology platform, represents a revolutionary new approach to the development of combination therapies based on identifying a fixed, synergistic ratio of the drugs pre-clinically, incorporating that ratio in a drug delivery vehicle and maintaining the ratio in patients. The company pipeline includes: CPX-1 (a liposomal formulation of irinotecan:floxuridine), currently in a Phase 2 trial in patients with colorectal cancer; CPX-351 (a liposomal formulation of cytarabine:daunorubicin), currently in a Phase 1 trial in patients with advanced leukemia; CPX 571 (a liposomal formulation of irinotecan:cisplatin), a preclinical stage compound; and multiple research programs. Based on the applications of CombiPlex, Celator is positioned to advance a broad pipeline of combination therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at http://www.celatorpharma.com.


'/>"/>
SOURCE Celator Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Celator Pharmaceuticals Raises Series C Financing in Excess of $22.5 Million
2. Celator(R) Pharmaceuticals Announces Positive Phase 2 Results for CPX-1 in Treatment of Colorectal Cancer
3. Celator(R) Pharmaceuticals Successfully Uses Nanoparticles to Administer Hydrophobic Drug Combinations
4. Celator(R) Pharmaceuticals Reports CPX-351 Shows Anti-Cancer Activity in Leukemia Patients
5. Idenix Pharmaceuticals Announces Completion of Proof-of-Concept Study for IDX899 in Treatment-Naive HIV-Infected Patients
6. Aegerion Pharmaceuticals, Inc. adds Peter Garrambone to Board of Directors, Secures Additional Capital for Clinical Trials
7. Diffusion Pharmaceuticals Announces Initiation of a Phase I/II Clinical Trial in Patients with Peripheral Arterial Disease (PAD)
8. Panacea Pharmaceuticals Announces Issuance of a U.S. Patent Covering Anti-HAAH Antibodies
9. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
10. Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000
11. Addrenex Pharmaceuticals New Hires Further Company Goal to Identify New Drugs for Adrenergic Regulation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- Any dentist who has made an implant supported denture ... of them do not even offer this as a viable ... costs involved. And those who ARE able to offer that ... cost that the majority of today,s patients would not be ... , founder of Dental Evolutions Inc. and inventor of Implanova ...
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... Ill. and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment ... Astellas Farma Brasil as the company,s second affiliate in Latin America . ... ... General Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. ... his M.D from the David Geffen School of Medicine at UCLA. He trained in ... to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World ... with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the ...
Breaking Medicine News(10 mins):