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 RegeneRx AMI Trial Placed on Clinical Hold | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

RegeneRx AMI Trial Placed on Clinical Hold

RegeneRx Biopharmaceuticals, Inc. has received a notice from the FDA indicating that, due to non-compliance with cGMP regulations by its contract manufacturer, the company’s Phase II trial of RGN-352 has been placed on clinical hold.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

RegeneRx Biopharmaceuticals, Inc. has received a notice from the FDA indicating that, due to non-compliance with cGMP regulations by its contract manufacturer, the company’s Phase II trial of RGN-352 has been placed on clinical hold. RGN-352 is an injectable formulation of Thymosin beta 4 in development for the treatment of acute myocardial infarction (AMI). The company was scheduled to begin enrolling patients in the trial in the coming weeks and it is unknown how long the clinical hold will be in place.

The clinical hold is limited to cGMP compliance issues at a specific contract manufacturing site and is not directed at the safety of RGN-352 or the Phase II development protocol. According to the company’s financial filings, it employs a single contract manufacturer for the drug product. As of March 31, 2010, the company was “in the early stages of qualifying backup manufacturers.”

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