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 shown to be safe and well-tolerated.

About Oral Mucositis

Oral mucositis is a side effect experienced by cancer patients undergoing chemotherapy or radiation therapy. There are approximately 140,000 head and neck cancer patients in the European Union; patients receiving radiation therapy are at risk of developing oral mucositis. In addition to killing tumor cells, radiation therapy also adversely affects surrounding tissues including the inner lining (mucosa) of the mouth. The resulting "oral mucositis;" is the number one patient-reported debilitating side effect of cancer therapy. The condition is debilitating, resulting in ulcers, severe pain, dryness of the mouth, and inability to swallow. Oral mucositis often leads to breaks in antineoplastic therapy. Currently, there are no satisfactory methods for the treatment of oral mucositis in patients with solid tumors in the European Union.

About ActivBiotics

ActivBiotics is currently in the process of selling its proprietary assets, including M40403, through an Assignment for the Benefit of Creditors. The bidding for the assets, which may be purchased separately or in combination, will be conducted on March 14, 2008. Any person interested in purchasing the assets or learning more about the bidding process should contact Mr. Joseph F. Finn, Jr., CPA.

Bidding packages, which contain technical information and the terms of sale, have been assembled and are ready to be distributed subject to a potential purchaser entering into a standard form confidentiality agreement.

Request for Further Information

Interested parties can obtain a bidder's package by contacting Joseph F. Finn, Jr., CPA (jffinnjr@earthlink.net, phone 781-237-8840), Finn, Warnke & Gayton, 167 Worcester Street, Suite 201, Wellesley Hills, MA 02481-3613. For technical information or questions regarding the products, please contact Christo Shalish, cshalish@activbiotics.com.


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

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:2/12/2016)... Holdings, Inc. (NASDAQ: IPHS ), a leading international producer ... will host a live conference call on Tuesday, February 23, ... and full year 2015 results. --> ... and full year results will be issued on Monday, February ... --> The conference call can be accessed ...
(Date:2/12/2016)... , Feb. 12, 2016   HeartWare International, ... conference call and webcast to discuss its financial results ... 2015, on Thursday, February 25, 2016 at 8:00 a.m. ... prior to the conference call and webcast.  On the ... financial results, highlights from the fourth quarter and business ...
(Date:2/12/2016)...  Memorial Hermann Health System has teamed up with ... bring a one-of-a-kind experience to pediatric patients at ... as 360-degree video and Google Cardboard, Howard was able ... giving the patients and their families an unexpected, and ... on video . Memorial Hermann IRONMAN ...
Breaking Medicine Technology:
(Date:2/12/2016)... Boca Raton, FL (PRWEB) , ... February 12, ... ... nation’s largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving ... patient services – hosted over 250 members of South Florida’s philanthropic community at ...
(Date:2/12/2016)... ... February 12, 2016 , ... As a former television executive, owner Tal ... and no time to decompress, Rabinowitz found herself drawn to a casual meditation class ... impact on her life, implementing a 20-minute-per-day meditation practice with her team. After her ...
(Date:2/12/2016)... ... February 12, 2016 , ... Itopia, ... announced the integration of Clarity Intelligence Platform (CIP) into Cielo®, a discovery, migration ... business intelligence (BI) to their small and medium business (SMB) clients. ...
(Date:2/12/2016)... ... 12, 2016 , ... The Jones Agency, a family owned insurance company with ... a cooperative charity drive with the Tarrant Area Food Bank in the hopes of ... families in need, the Tarrant County Food Bank offers hope and security to the ...
(Date:2/12/2016)... ... February 12, 2016 , ... Donor Network West, the organ procurement organization that ... partnership with San Ramon Regional Medical Center. Under the collaboration, the first of its ... to accommodate a more certain time frame for donor families for the recovery of ...
Breaking Medicine News(10 mins):