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
'/>"/>

SOURCE Polyphenon Pharma
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

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:12/14/2009)... Inc. is pleased to announce that the United ... number 7,599,057 titled "Method and Apparatus for Detection ... company. The patent covers the core technology which ... of this patent supports the underlying strategy as ... commercialization," said Dave Dingott, CEO and President of ...
(Date:12/14/2009)... Cardium Therapeutics (NYSE Amex: CXM ... of GAM501 (Ad5PDGF-B/Collagen) in the Treatment of Diabetic ... and Industry Conference held December 10-13, 2009 in ... is attended by top industry leaders and renowned ... Dr. Barbara K. Sosnowski, Cardium,s Vice President ...
(Date:12/14/2009)... BERKELEY HEIGHTS, N.J., Dec. 14 ... a worldwide provider of secure Health Information ... that Home Care of the Carolinas ("HCC"), ... Inc. ("AMI"), a durable medical equipment supplier, ... to streamline and standardize processes for the ...
Breaking Medicine Technology:Cardium Presents at Tenth Annual Wound Healing: Science and Industry Conference on Matrix Wound Healing Clinical Development 2Cardium Presents at Tenth Annual Wound Healing: Science and Industry Conference on Matrix Wound Healing Clinical Development 3Cardium Presents at Tenth Annual Wound Healing: Science and Industry Conference on Matrix Wound Healing Clinical Development 4Home Care of the Carolinas and Alliance Medical, Inc. Select Authentidate's Inscrybe Healthcare to Improve Care Order Processing 2Home Care of the Carolinas and Alliance Medical, Inc. Select Authentidate's Inscrybe Healthcare to Improve Care Order Processing 3Home Care of the Carolinas and Alliance Medical, Inc. Select Authentidate's Inscrybe Healthcare to Improve Care Order Processing 4Study Links Yo Yo Dieting to Addiction 61264 1Study Links Yo Yo Dieting to Addiction 61264 2Study Links Yo Yo Dieting to Addiction 61264 3Neurological Surgery P C of Long Island NY Adds New Specialists and Opens New Flagship Facility in Lake Success NY 61262 1Neurological Surgery P C of Long Island NY Adds New Specialists and Opens New Flagship Facility in Lake Success NY 61262 2Neurological Surgery P C of Long Island NY Adds New Specialists and Opens New Flagship Facility in Lake Success NY 61262 3Healthcare Organizations Face Tough Marketing Challenges GY 26amp 3BK Asks Are You Relevant 3F 61259 1Healthcare Organizations Face Tough Marketing Challenges GY 26amp 3BK Asks Are You Relevant 3F 61259 2Healthcare Organizations Face Tough Marketing Challenges GY 26amp 3BK Asks Are You Relevant 3F 61259 3
(Date:12/14/2009)... Pasierb, President ,, NEW YORK, Dec. 14 ... the Future study (MTF) -- the largest survey on ... 12th graders -- underscores that teens, intentional abuse of ... a cause for concern, with an alarming number of ... relatives. ,, Teen Abuse of Medication ...
(Date:12/14/2009)... SANTA ANA, Calif., Dec. 14 Grubb & Ellis ... directors has authorized a daily distribution to stockholders of record ... the period commencing on Jan. 1, 2010 and ending on ... on 365 days in the calendar year and will be ... a purchase price of $10.00 per share. These distributions ...
(Date:12/14/2009)... 14 On December 9, 2009, the United ... government,s position that private insurance companies are "plans" and ... Although other federal courts have held that contracts issued ... under Title 18 Section 1347, US vs. Frost ... has been held to be a "plan," because, as ...
(Date:12/14/2009)... had been treated, hadn,t spread, study finds , , MONDAY, ... the risk of death in male colon cancer survivors, ... 1986, included 668 men who,d been treated for stage ... had not spread (nonmetastatic cancer). Every two years, the ... new cancer and disease diagnoses, as well as their ...
(Date:12/14/2009)... is small and shouldn,t worry most users, researcher says ... who take antidepressants may have a small but statistically ... women not on the medications, a new study finds. ... significance," stressed Dr. Jordan W. Smoller, an associate professor ... of a report in the Dec. 14 issue of ...
Breaking Medicine News(10 mins):Health News:Partnership for a Drug-Free America(R) Responds to 2009 Monitoring the Future Study Results 2Health News:Partnership for a Drug-Free America(R) Responds to 2009 Monitoring the Future Study Results 3Health News:Grubb & Ellis Healthcare REIT II Declares Initial Distribution 2Health News:Grubb & Ellis Healthcare REIT II Declares Initial Distribution 3Health News:Insurance Now Subject to Federal Jurisdiction 2Health News:Physical Activity May Prolong Survival After Colon Cancer 2Health News:Antidepressants May Raise Women's Stroke Risk 2Health News:Antidepressants May Raise Women's Stroke Risk 3
... "Executive of the Year." , ... Birmingham, AL (PRWEB) ... International, and its CEO Jeffrey Tolbert took home two awards in ... Business Journal., , ,AirMed International was announced as the winner in ...
... follows nearly two-year ... delay in releasing data, WASHINGTON, Aug. ... Control and Prevention (CDC) increase,the estimate of new HIV infections in ... does not necessarily indicate an,ongoing increase in the annual estimated infection ...
... of lopinavir/ritonavir, study says , , FRIDAY, ... tazanavir/ritonavir (A/R) is as effective as twice-daily treatment ... starting antiretroviral treatment for the first time, a ... the researchers recommended once-daily A/R as a first-line ...
... study regarding Cognitive Behavioral Therapy as a treatment for Body Dysmorphic Disorder. ... into a crisis. BDD is similar to other disorders that respond ... thoughts on the study. , ... New York, NY (PRWEB) August 2, ...
... KNSY ) today announced that it will release ... ended June 30, 2008 at 7:00 A.M.,Eastern Time on ... CEO, will be hosting a teleconference,discussing the earnings results ... To participate in the teleconference call, dial 612-332-0345. ...
... the most aggressive types of brain tumor, have an ... a group of proteins known as receptor tyrosine kinases ... these RTK inhibitors have met with limited clinical success ... such treatment and most subsequently relapse after only a ...
Other Medicine News:Health News:Air Ambulance Company AirMed International Wins Multiple "Best in Business" Awards from Birmingham Business Journal 2Health News:New HIV Infection Figures from CDC Underscore Need for National AIDS Strategy for the U.S. 2Health News:Once-Daily Combo Works for New HIV Patients 2Health News:Has Hollywood's Diet Obsession Forced the US Government to Take Action? 2Health News:Has Hollywood's Diet Obsession Forced the US Government to Take Action? 3Health News:Kensey Nash Corporation Announces its Fourth Quarter and Fiscal Year End 2008 Earnings Release Date and Teleconference 2
... lumen tubes for ... ,Each SHER-I-BRONCH ... packaged with pre-loaded ... suction catheters and ...
Used for endobronchial blockade of the left or right lung for procedures which require one-lung ventilation. Supplied sterile in peel-open packages. Intended for one-time use....
... allows quick and safe access ... of acute respiratory distress with ... consists of a pre-assembled emergency ... syringe attached to a padded ...
Used for emergency airway access when endotracheal intubation cannot be performed. Supplied sterile in peel-open packages. Intended for one-time use....
Medicine Products: