Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Stem Cell Therapeutics Receives U.S. Orphan Drug Designation

Published: Friday, November 01, 2013
Last Updated: Friday, November 01, 2013
Bookmark and Share
Company receives drug designation for the use of tigecycline to treat AML.

Stem Cell Therapeutics Corp. has announced that it has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the use of tigecycline in the treatment of acute myeloid leukemia (AML).

Orphan Drug designation is granted to therapeutics treating rare diseases affecting less than 200,000 people in the U.S. The designation entitles the sponsor to seven years of market exclusivity as well as opportunities for additional funding and expert protocol assistance.

“Orphan Drug status significantly enhances the commercial potential of tigecycline in AML, a disease which is notoriously difficult to treat", said the company’s Vice President, Drug Development, Dr. Penka Petrova.

Petrova continued, “Through its unique mechanism of action and synergy with existing AML therapies, tigecycline has the potential to positively impact the standard of care in this disease”.

The company’s program is based on Dr. Aaron Schimmer’s published findings that tigecycline, an FDA-approved antibiotic, selectively targets leukemia cells and leukemic stem cells by inhibiting mitochondrial protein synthesis and thus shutting down the cells’ energy supply.

A Phase I Canadian and U.S. multicenter dose-escalation clinical trial in patients with relapsed or refractory AML is nearing completion.

“The Orphan Drug designation covers tigecycline as an active ingredient and is independent of the drug formulation,” added Dr. Bob Uger, the company’s Chief Scientific Officer. “We are investigating improved formulations of tigecycline, which we believe will be critical for the commercialization of this technology”.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,400+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Toxin from Salmonid Fish has Potential to Treat Cancer
Researchers from the University of Freiburg decode molecular mechanism of fish pathogen.
New Diabetes Drug has Unexpected Side Effect
A type of drug used to treat diabetes may reduce the risk of developing Parkinson’s disease, according to new research.
Researchers Develop Vaccine that Protects Primates Against Ebola
A collaborative team from The University of Texas Medical Branch at Galveston and the National Institutes of Health have developed an inhalable vaccine that protects primates against Ebola.
Cannabis May Be Used to Treat Fractures
TAU researcher finds non-psychotropic compound in marijuana can help heal bone fissures.
A Novel Drug to FIght Malaria
An international team of scientists has announced that a new compound to fight malaria is ready for human trials.
New Cell Structure Finding Might Lead to Novel Cancer Therapies
University of Warwick scientists in the U.K. say they have discovered a cell structure which could help researchers understand why some cancers develop.
Creating More Potent Vaccines
Yale researchers uncovered a new role for a type of immune cell, known as regulatory T cells, in promoting long-term immunity.
Potential Therapeutic for Blinding Eye Disease
NIH research points to microglia as potential therapeutic target in retinitis pigmentosa.
Potential New Class of Cancer Drugs
Scientists have found a way to stop cancer cell growth by targeting the Warburg Effect, a trait of cancer cell metabolism that scientists have been eager to exploit.
Global Search for Next Antibiotic
University of Queensland researchers have launched a global search to discover antibiotics capable of combating superbug bacteria that are resistant to current antibiotics.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!