Navigation Links
Polyphenon Pharma Receives Orphan Drug Designation for Its Botanical Drug, Polyphenon E, for the Treatment of CLL
Date:7/28/2008

NEW YORK, July 28 /PRNewswire/ -- Polyphenon Pharma, an emerging research-based pharmaceutical company, today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to its botanical drug, Polyphenon E(R), for the treatment of chronic lymphocytic leukemia (CLL). A Phase II study is currently underway at the Mayo Clinic in Rochester, Minnesota where researchers are studying the effects of an oral daily dose of Polyphenon E in CLL patients.

"The FDA Orphan Drug Designation for Polyphenon E represents a significant milestone in the development of this drug," said Stig Ogata, Polyphenon Pharma's Chief Operating Officer. "Orphan drug status provides incentives that can help accelerate the development process of Polyphenon E as an oral treatment for patients with CLL. This in turn could lead to other potential development opportunities for this drug in the area of oncology."

The FDA grants Orphan Drug Designation to encourage biotechnology and pharmaceutical companies to develop products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 people in the United States. This designation will entitle Polyphenon Pharma to seven years of marketing exclusivity for the drug upon FDA approval.

Polyphenon E contains highly characterized catechins that are extracted from green tea leaves through a proprietary process. The primary catechin in Polyphenon E, epigallocatechin gallate (EGCG), has been shown to affect many processes in the body related to abnormal cellular activity that can lead to cancer. Preclinical studies indicate that the catechins present in Polyphenon E may have multiple methods of action.

About CLL

Chronic Lymphocytic Leukemia (CLL) is a type of cancer of the blood and bone marrow that progresses more slowly than acute leukemia. It affects a group of white blood cells called lymphocytes, which typically fight infection. Each year, about 10,000 people in the United States are diagnosed with CLL.

About Polyphenon Pharma

Polyphenon Pharma is a privately held subsidiary of the Japanese company, Mitsui Norin Co., Ltd., which discovered and manufactures the botanical drug Polyphenon E. Headquartered in New York, NY, Polyphenon Pharma focuses on the clinical development of Polyphenon E across a broad spectrum of therapeutic areas in which it has potential activity, including infectious disease/virology, urology, neurology, and oncology. The Company's two-stage approach to pursuing the full potential of Polyphenon E is to use its own resources to advance drug candidates through Phase II clinical trials or proof-of-concept studies and then seek global pharmaceutical partners to complete late-stage development and commercialization in multiple countries. More information is available at http://www.polyphenon-pharma.com

This press release contains forward-looking statements that involve significant risks and uncertainties. The actual results, performance or achievements of the Company might differ materially from the results, performance or achievements of the Company expressed or implied by such forward-looking statements. Such forward-looking statements include, without limitation, those regarding the development plans of the Company and the expected results of our development. We can provide no assurance that such development will proceed as currently anticipated or that the expected results of such development will be realized. We are subject to various risks, including the uncertainties of clinical trials, drug development and regulatory review, the early stage of our product candidates, our reliance on collaborative partners, our need for additional capital to fund our operations, our history of losses, and other risks inherent to the biopharmaceutical industry.


'/>"/>
SOURCE Polyphenon Pharma
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmatech, Inc. Contracts for Five New Just-in-Time Clinical Trials
2. Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer
3. FluoroPharma Announces Positive Phase I Safety Results for BFPET(TM), Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission Tomography (PET)
4. InCode BioPharmaceutics, Inc. Announces Key Data Supporting New Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
5. CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study
6. Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application for Phase IIb Clinical Trial With MPI-676 in Endometriosis
7. BioNumerik Pharmaceuticals Observes Evidence of a Survival Increase in Lung Cancer Patients Participating in Tavocept(TM) Clinical Trial
8. Raptor Pharmaceuticals Enters Collaboration Agreement with UC San Diego in Liver Disease
9. MAP Pharmaceuticals Announces Publication of MAP0004 Study in Current Medical Research and Opinion
10. Rib-X Pharmaceuticals Initiates Phase 2 Trial for RX-3341 In Complicated Skin and Skin Structure Infections
11. Edison Pharma Hits Milestone as A0001 Enters Phase 1 Clinical Development
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/25/2017)... --  Montrium , an industry leader in powerful ... Trial Master Files & Inspection Readiness Conference ( ... Services has selected eTMF Connect to ... a leading European contract research organization (CRO), will ... enable greater collaboration with sponsors, improve compliance and ...
(Date:9/23/2017)... 22, 2017 Janssen Biotech, Inc. (Janssen) announced ... from the U.S. Food and Drug Administration (FDA) for ... for the treatment of moderately to severely active rheumatoid ... data are needed to further evaluate the safety of ... RA. "We ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and Nutrition ... the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD market ... can be easily incorporated into liquid products, while reducing costs to end users. , ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , ... mock evacuation of the facility as part of a disaster drill on October 3rd. ... EMS and Shelton City Emergency Manager, as well as the Connecticut Long Term ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob Lowe, ... in a new episode of "Success Files," which is an award-winning educational program ... investigates each subject in-depth with passion and integrity. , Sciatica occurs when the ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
Breaking Medicine News(10 mins):