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:12/5/2016)... Health and Gateway Health proudly announce a dynamic collaboration that ... plan members with specific high risk needs. In ... group of consumers, Wellbridge combines technology and population expertise with ... members, daily behaviors and lifestyle. ... , , ...
(Date:12/5/2016)...  New research by the CVS Health (NYSE: ... U.S. Department of Health and Human Services, Office ... (ASPR), published online today in JAMA Internal ... patients with chronic conditions to refill medications prior ... affirms that public-private partnerships can facilitate timely pharmacy ...
(Date:12/5/2016)... 5, 2016  BD (Becton, Dickinson and Company) (NYSE: ... company, will demonstrate an enhanced technology platform designed with ... the company,s leading Pyxis™ and Alaris™ systems, at this ... Midyear Meeting being held in Las ... national data show that approximately 68 percent of medication ...
Breaking Medicine Technology:
(Date:12/4/2016)... ... 03, 2016 , ... Penrose Senior Care Auditors® was announced ... evening at the 26th Annual SMU Cox Dallas 100™ Awards Ceremony and Banquet ... for Entrepreneurship. Dallas 100™, co-founded by the Caruth Institute, honors the ingenuity, commitment ...
(Date:12/4/2016)... , ... December 04, 2016 , ... ... major cosmetic surgery can now take advantage of a cosmetic procedure known as ... rejuvenation treatment that reduces the appearance of age spots, fine lines, uneven ...
(Date:12/4/2016)... PITTSBURGH, PA (PRWEB) , ... December 04, 2016 , ... ... not enough. One must brush properly to achieve optimal results. This important necessity inspired ... saw a need for a way to ensure that people break or avoid bad ...
(Date:12/2/2016)... ... ... Lori G. Cohen and Sara K. Thompson , shareholders in ... Conference Institute’s 21st Drug & Medical Device Litigation Conference , taking place in New ... Cohen, who chairs the firm’s Pharmaceutical, Medical Device & Health Care Litigation Practice and ...
(Date:12/2/2016)... DIEGO, Calif. (PRWEB) , ... December 02, 2016 , ... ... Event at the Hard Rock Hotel San Diego honoring the 2016 MPN Heroes—eight individuals ... myeloproliferative neoplasms (MPNs) by going above and beyond the standard of care, demonstrating leadership ...
Breaking Medicine News(10 mins):