Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA
Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine deiminase) from the US Food and Drug Administration.
The designation has been granted for the treatment of malignant pleural mesothelioma in the USA and the European Union, following a successful randomized Phase II trial in argininosuccinate synthetase-deficient MPM patients with ADI-PEG 20 as monotherapy.
Polaris is currently conducting a Phase I trial of ADI-PEG 20 in combination with pemetrexed and cisplatin, the approved first-line treatment for MPM, for the treatment of MPM and non-squamous non-small cell lung carcinoma. It is also investigating the therapy for other diseases, including breast cancer, melanomas, ovarian cancer, and hepatocellular carcinoma. A Phase III trial is currently underway for ADI-PEG 20 as a monotherapy to treat hepatocellular carcinoma.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze