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:2/10/2016)... February 10, 2016 --> ... (Liquid & Gas), and Spectroscopy Market by Industry (Oil & ... Pulp & Paper, Metal & Mining, and Others), And ... the global market is expected to grow to USD ... 8.6% between 2015 and 2020. Browse 82 ...
(Date:2/10/2016)... , Feb. 10, 2016 CSI Specialty ... with the launch of the Specialty Pharmacy Podcast. A ... industry-first, aimed at providing real-world education, discussion and context ... --> --> The Specialty ... CEO of CSI Specialty Group Suzette DiMascio, CHE, CMCE, ...
(Date:2/10/2016)... SAN DIEGO , Feb. 10, 2016 ... leader in viral gene therapy manufacturing, and Renova™ Therapeutics, ... heart failure and other chronic diseases, have entered into ... process and produce cGMP-grade RT-100 (Ad5.hAC6) Drug Product for ... --> --> This relationship will ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... 10, 2016 , ... AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company ... and full year ended December 31, 2015 on Monday, February 29, 2016 after the ... investment community following the release at 4:30 PM ET. Investors interested in participating by ...
(Date:2/10/2016)... Boston, Massachusetts (PRWEB) , ... February 10, 2016 ... ... practice models to effectively measure change in their patients. Research shows that the ... traditional methods. To help therapists overcome this challenge and learn more about the ...
(Date:2/10/2016)... Palm Beach, Florida (PRWEB) , ... February 10, ... ... & Country Club) announced that it has been awarded the prestigious Distinguished Emerald ... the World award program conducted by BoardRoom magazine, one of the most respected ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... 1 UNF Drive, Jacksonville, FL 32224, February 26th: Amateur & Professional Divisions ... Division - Time: 7:00pm – 10:00pm | Ticket Prices $30, Social Media: ...
(Date:2/10/2016)... ... February 10, 2016 , ... The recreational use of ... in the state still face a lot of restrictions as to where they can ... for private, personal use” and that cannabis “may not be consumed openly or publicly.” ...
Breaking Medicine News(10 mins):