Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 SCT's AML Treatment Gets Orphan Status | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

SCT’s AML Treatment Gets Orphan Status

Phase I trial nearly complete

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Stem Cell Therapeutics Corp. has received Orphan Drug designation from the FDA for the use of tigecycline in the treatment of acute myeloid leukemia (AML).

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.

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.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics