Navigation Links
ActivBiotics Receives Orphan Drug Designation from the European Medicines Agency for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis Indication
Date:2/5/2008

WELLESLEY HILLS, Mass., Feb. 5 /PRNewswire/ -- Joseph F. Finn, Jr., CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced today that The Committee for Orphan Drug Products of the European Medicines Agency (EMEA) has granted Orphan Drug Designation for M40403 for the prevention of oral mucositis (OM) in head and neck cancer patients receiving radiotherapy.

The development of oral mucositis during radiation therapy of head and neck cancers is the major reason for poor compliance with and early discontinuation of radiation therapy by patients being treated for their condition.

European Union Orphan Drug Designation was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the European Union. Orphan Drug Designation provides an important economic incentive for the development of new products in the cancer field. EU Orphan Designation provides for 10 years of market exclusivity, reduction in EU regulatory fees, and additional regulatory support for R&D initiatives.

ActivBiotics has also applied for Orphan Drug Designation with the U.S. Food and Drug Administration.

About M40403

This investigational small molecule mimics the action of a natural component of the cells, an enzyme called superoxide dismutase. Superoxide dismutase is thought to have a double effect, first through the reduction of inflammation, and secondarily through the decreased rate of programmed cell death (apoptosis). As mucositis involves inflammation, the positive effect of the M40403 over this process is expected to have a beneficial effect in the condition. M40403 has shown efficacy in an animal model where oral mucositis was induced by acute irradiation. The compound has been evaluated in approximately 700 subjects in several Phase I and II clinical trials, and was
'/>"/>

SOURCE ActivBiotics
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. ActivBiotics to Present Results of Pivotal Study in the Treatment of Peripheral Arterial Disease at AHA Meeting
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
7. CryoCor Receives FDA Approval for Right Atrial Flutter
8. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
9. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
10. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
11. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2013)... INDIANAPOLIS , 19. Juni 2013 ... bekannt, dass mit der Entwicklung von ... bahnbrechender Schritt in der Beschichtung mit ... die Vorteile von biokompatiblem Parylene mit ... effektive Beseitigung schädlicher Mikroorganismen auf beschichteten ...
(Date:6/19/2013)... , June 19, 2013  It may seem like ... cure for breast cancer. But these were two of the ... 95 th Annual Meeting & Expo that just convened ... are saying this focus by some of the top internal ... culture,s obsession with new research that can not only save ...
(Date:6/18/2013)... , June 19, 2013 ... Parkinson,s disease (PD) patients as add-on to levodopa ... improvement in motor symptoms in fluctuating PD patients ... Newron Pharmaceuticals S.p.A. ("Newron"), a research and ... therapies, and its partner Zambon S.p.A., a pharmaceutical ...
Breaking Medicine Technology:Specialty Coating Systems gibt die Einführung einer neuen antimikrobiellen Parylene-Technologie bekannt 2"Miracle" Breast Cancer Drug and "Youth Hormone" Pill Steal Show at Prestigious Endocrine Society Conference 2"Miracle" Breast Cancer Drug and "Youth Hormone" Pill Steal Show at Prestigious Endocrine Society Conference 3"Miracle" Breast Cancer Drug and "Youth Hormone" Pill Steal Show at Prestigious Endocrine Society Conference 4Safinamide Phase III Study Results Presented at 2013 MDS Meeting 2Safinamide Phase III Study Results Presented at 2013 MDS Meeting 3Safinamide Phase III Study Results Presented at 2013 MDS Meeting 4Safinamide Phase III Study Results Presented at 2013 MDS Meeting 5Safinamide Phase III Study Results Presented at 2013 MDS Meeting 6
... , - Research Collaboration ... Jubilant Organosys Ltd, headquartered ... subsidiary,Jubilant Biosys Ltd, has signed a research,collaboration agreement ... into the international pharmaceutical company,s pre-clinical,pipeline. Under the ...
... EPSScentral LLC today announced its readiness to assist ... the face of WHO,s phase 5 classification of the ... 5 "... is a strong signal that a pandemic ... measures is short." (Logo: http://www.newscom.com/cgi-bin/prnh/20080701/DC26612LOGO ...
Cached Medicine Technology:Jubilant Enters Research Collaboration With AstraZeneca 2Jubilant Enters Research Collaboration With AstraZeneca 3Jubilant Enters Research Collaboration With AstraZeneca 4EPSScentral Responds to Pandemic Alert 2
(Date:6/19/2013)... Scott Tischler of Tischler Brothers Fitness unveils how to kick ... very first thing that should be done every morning is ... The body is dehydrated when it first wakes up and ... and will also kick start the metabolism first thing in ... the water to body temperature before it can be digested ...
(Date:6/19/2013)... According to Vanessa Grigoriadis, a contributing ... are creating new designer drugs featuring psychoactive effects by ... documents and patented formulas. She reported her findings to ... on June 4. , “Some of these drugs could ... on humans. Maybe some of them are tested on ...
(Date:6/19/2013)... (PRWEB) June 19, 2013 As Mirena ... LLP highlights a recent news story from an NBC ... effects of the hormone-based contraceptive device. The Rottenstein Law ... to file Mirena lawsuits and who are ... The U.S. Food and Drug Administration has logged more ...
(Date:6/19/2013)... Sudden cardiac arrest can strike anyone, even a child, at ... minutes after cardiac arrest, but the average emergency medical service ... is highly probable if an automated external defibrillator or ... to this dire reality, US Representative Lois Capps (CA-24) has ... which would provide support for AED and CPR training programs ...
(Date:6/19/2013)... (PRWEB) June 19, 2013 Transvaginal mesh lawsuits ... matter. A May 31 order addressed how to handle evidence ... preserve and test samples and device components removed from patients. ... informational website , complete with news about the device and ... are to obtain the samples from the medical facilities that ...
Breaking Medicine News(10 mins):Health News:Dangerous Designer Drugs Dodge Legal System 2Health News:Dangerous Designer Drugs Dodge Legal System 3Health News:Rottenstein Law Group LLP Comments on News Reports of Mirena IUD Side Effects 2Health News:AED.com Supports Automated External Defibrillator (AED) Legislation in Schools in US and UK 2Health News:Transvaginal Mesh Lawsuit News: NJ Mesh Consolidation Cases Moving Along, Rottenstein Law Group LLP Reports 2
... 11 MedImmune, the,global biologics unit of AstraZeneca, ... Holdings, Inc., announced today that they have entered,into ... commercialize,SBI Biotech,s anti-ILT7 protein for the potential treatment ... MedImmune has,global rights to any resulting product candidates ...
... back,to school, parents gain flexibility in what their ... Department of Agriculture (USDA),announced parents or legal guardians ... cow,s milk for children receiving National School Lunch ... growing diversity of,participants in the School Nutrition Programs ...
... Sept. 11 /Xinhua-PRNewswire-FirstCall/ -- Genesis,Pharmaceuticals Enterprises, Inc. (OTC ... pharmaceutical company in the People,s Republic,of China, today ... a,total value of approximately $12 million over the ... the 43rd Annual New Drugs Conference (the,"Conference") sponsored ...
... MIT study suggests , , THURSDAY, Sept. 11 (HealthDay News) -- ... your eyes. , A team of neuroscientists publishing ... they have tricked the brain into confusing one object the ... humans to learn to recognize objects. , People never really ...
... waiting room time more enjoyable and informative for patients, ... and helping doctors become more profitable in the process. ... is Ear, Nose & Throat Associates of South Florida ... month in Chicago at AOA-26 and OTO EXPO and ...
... NBTY, Inc. (NYSE:,NTY) (http://www.NBTY.com ), a leading global ... will web cast the,presentation by Harvey Kamil, President and ... Ideas Conference in New York on Wednesday,September 17, 2008., ... live on NBTY,s web site, (http://www.nbty.com ) on Wednesday, ...
Cached Medicine News:Health News:MedImmune Further Expands Autoimmune Disease Research Program Through Collaboration with SBI Biotech 2Health News:Parents Can Now Ask Schools to Serve Soymilk 2Health News:Genesis Pharmaceuticals Received New Purchase Orders Worth $12 Million 2Health News:Genesis Pharmaceuticals Received New Purchase Orders Worth $12 Million 3Health News:Time Teaches Brain to Recognize Objects 2Health News:Mediplay Makes Marketing More Profitable For Physicians 2Health News:Mediplay Makes Marketing More Profitable For Physicians 3Health News:NBTY to Web Cast Presentation at CL King Best Ideas Conference 2
Combination heat and moisture exchanger and bacterial/viral filters for Anesthesia and Respiratory applications....
Indications For Usage: ,Adult (recommended tidal volume >150ml), single patient use on anesthetized patients and respiratory care patients who require a breathing circuit. The product is intended to ...
HME w/bacterial viral filter w/CO2...
Indications For Usage: ,Infant (recommended tidal volume 20-70ml), single patient use on anesthetized patients and respiratory care patients who require a breathing circuit. The product is intended ...
Medicine Products: