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 Polaris Begins AML Trial | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

Polaris Begins AML Trial

FDA approves IND for ADI-PEG 20

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Polaris Group has filed an IND application with the FDA to begin Phase I trials to test ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of acute myeloid leukemia (AML). The FDA has reviewed the application, waived the 30-day review period and allowed treatment to begin.

Polaris Group has previously filed other INDs under which it is conducting clinical trials on ADI-PEG 20 for the treatment of multiple other indications, including metastatic melanoma, prostate cancer, and hepatocellular carcinoma. The latter indication is in a global Phase III study.

The company contends that ADI-PEG 20 has a novel mechanism of action and well documented tolerability that makes it a good candidate both as monotherapy and to combine with other agents, including cytotoxics.

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