Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
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 2,500+ 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.

Related Content

SCT Changes its Name to Trillium Therapeutics Inc.
Company has filed articles of amalgamation to merge with Trillium Therapeutics.
Tuesday, June 03, 2014
SCT to Provide Update on CD47 Program at the 2014 AACR Annual Meeting
Announcing a key difference between SIRPaFc and other CD47-blocking agents.
Friday, April 04, 2014
Stem Cell Therapeutics Strengthens its Board of Directors
Adds US industry veterans with broad financial and clinical expertise.
Tuesday, March 11, 2014
Stem Cell Therapeutics Announces Resignation of Director
Mr. David Allan has resigned from Company’s board of directors.
Thursday, January 30, 2014
Stem Cell Therapeutics Announces Appointment of Dr. Calvin R. Stiller as Chairman
Dr. Stiller has been a member of the Board since July 2011 and served as Lead Director and Chair of the Governance and Nominating Committee.
Thursday, January 30, 2014
Stem Cell Therapeutics Provides Corporate Update
Company provides six-month corporate update.
Monday, January 20, 2014
Stem Cell Therapeutics Completes $33 Million Private Placement
Financing proceeds used to advance the Company’s CD47 cancer stem cell program.
Friday, December 20, 2013
Stem Cell Therapeutics Appoints Dr. Robert Kirkman to its Board of Directors
Provides update on $33 million offering.
Wednesday, December 18, 2013
Stem Cell Therapeutics Acquires Complementary Antibody Program
The company has entered into an option agreement to exclusively license worldwide rights to a panel of fully human monoclonal antibodies targeting the SIRPa protein (CD172a).
Thursday, October 17, 2013
Stem Cell Therapeutics Advances CD47 Antagonist Program into Ind-Enabling Phase
Stem Cell Therapeutics Corp. announced that it has advanced its CD47 antagonist program into an Investigational New Drug (IND) enabling phase.
Monday, September 09, 2013
SCT Acquires an Exclusive Option to License Prostate Cancer Stem Cell Assets
Collaboration with internationally renowned prostate cancer research group.
Monday, August 12, 2013
Stem Cell Therapeutics Acquires an Exclusive Option to License Prostate Cancer Stem Cell Assets
Collaboration with internationally renowned prostate cancer research group.
Monday, August 12, 2013
SCT Licenses Exclusive Rights to Clinical Cancer Stem Cell Program
Corporate refocusing mission completed.
Friday, April 19, 2013
SCT Announces Joint-Venture Agreement with Reneu and Nexgen
Company to move the combined technologies into clinical trials with a target of clinical initiation in 2014.
Wednesday, February 20, 2013
SCT Announces Agreement with Trillium for Merger
Continuing Stem Cell Therapeutics' commitment to expansion.
Wednesday, February 06, 2013
Scientific News
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
Low-level Arsenic Exposure Before Birth Associated with Early Puberty in Female Mice
Study examine whether low-dose arsenic exposure could have similar health outcomes in humans.
Inciting an Immune Attack On Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Intensity of Desert Storms May Affect Ocean Phytoplankton
MIT study finds phytoplankton are extremely sensitive to changing levels of desert dust.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Scroll Up
Scroll Down
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!