Navigation Links
Polaris Group Files New IND for ADI-PEG 20 in Breast Cancer
Date:10/22/2013

SAN DIEGO, Oct. 22, 2013 /PRNewswire/ -- Polaris Group announced today that it has filed an Investigational New Drug Application (IND) application with the United States Food and Drug Administration (FDA) to begin Phase 1 clinical trials to test ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of breast cancer. Polaris Group has previously filed another IND under which it is conducting clinical trials on ADI-PEG 20 for the treatment of multiple other indications, including hepatocellular carcinoma. The latter indication is already in a global Phase 3 study.

"We are pleased to file another IND with the FDA and expand the portfolio of indications for which ADI-PEG 20 is under development. We look forward to initiating a clinical study of ADI-PEG 20 in breast cancer, and also to initiating other studies of ADI-PEG 20," said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris Group. "The proposed breast cancer study will combine ADI-PEG 20 with doxorubicin, a first-line therapy in breast cancer. ADI-PEG 20 combination studies are currently underway with docetaxel in prostate cancer and non-small cell lung carcinoma, and with cisplatin in melanoma. We believe its novel mechanism of action and well documented tolerability makes ADI-PEG 20 an ideal candidate to combine with other agents, including cytotoxics."

About ADI-PEG 20

ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers, especially those carrying a major metabolic defect that renders such cancer cells, unlike normal cells, unable to internally synthesize arginine. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, it is believed these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to systemically deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency.

About Polaris Group

Polaris Group is a privately held biopharmaceutical company that specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. The company's lead therapeutic, ADI-PEG 20, is currently being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris Group is also investigating ADI-PEG 20 as a treatment for other cancers. In addition to the ADI-PEG 20 program, Polaris Group is researching and developing other biotherapeutic agents and is advancing a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.

For additional information please visit www.polarispharma.com


'/>"/>
SOURCE Polaris Group
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. ePharmaSolutions To Acquire Global Patient Recruitment Firm Polaris BioPharma
2. WIRB-Copernicus Group Leaders Speak at Global Clinical Research Summit in South Korea
3. Global Stem Cells Group, Inc. Announces Worldwide Alliance with EmCyte Corp. to Promote In-office Regenerative Medicine Solutions
4. FarHawk Marketing Services Represents IonBench™ and MS Noise™ at the Greater Boston Mass Spectrometry Discussion Group Corporate Night October 3rd
5. Reimbursement Marketing Agency Element Marketing Group Inc. Opens New Office in Irvine, California
6. Dennis R. Hill, MD to Speak at the American Cancer Society Man-to-Man Support Group to Discuss HDR Brachytherapy for Prostate Cancer Treatment
7. Bangkok Hospital Group Selects ClinicalKey to Enhance Medical Practice and Improve Patient Care
8. The Arrow Group of Animal Hospitals in Central Arizona Partners with Vet-Stem, Inc. to Bring Stem Cell Therapy to Their Patients
9. Dennis R. Hill, MD to Speak at the American Cancer Society Man-to-Man Support Group to Discuss HDR Brachytherapy for Prostate Cancer Treatment
10. RGF Environmental Group Acquires AFL Industries
11. Medflow EHR Achieves ONC-ACB Certification by Drummond Group
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... ... ... Scientists at the University of Athens say they have evidence that the variety ... that could lead to one good one. Surviving Mesothelioma has just posted an article ... team evaluated 98 mesothelioma patients who got a second kind of drug ...
(Date:5/25/2016)... ... May 25, 2016 , ... ... and Drug Administration (FDA) has granted the company’s orphan drug designation request covering ... orphan drug designation granted by the FDA. , Spinocerebellar ataxia is a ...
(Date:5/24/2016)... ... May 24, 2016 , ... Last week, Callan Capital, ... executives and entrepreneurs, held The Future of San Diego Life Science event at the ... life science community attended the event with speakers Dr. Rich Heyman, former CEO of ...
(Date:5/23/2016)... ... 23, 2016 , ... PrecisionAg® Media has released its latest ... The paper outlines the key trends that are creating both opportunities and challenges ... lot of highs and lows as the precision agriculture market has grown and ...
Breaking Biology Technology:
(Date:3/22/2016)... India , March 22, 2016 /PRNewswire/ ... market research report "Electronic Sensors Market for Consumer ... Proximity, & Others), Application (Communication & IT, ... Geography - Global Forecast to 2022", published ... industry is expected to reach USD 26.76 ...
(Date:3/21/2016)... March 22, 2016 Unique ... passcodes for superior security   ... provider of secure digital communications services, today announced it ... and offer enterprise customers, particularly those in the Financial ... and voice authentication within a mobile app, alongside, and ...
(Date:3/17/2016)... 2016 ABI Research, the leader in ... biometrics market will reach more than $30 billion ... 2015. Consumer electronics, particularly smartphones, continue to boost ... to reach two billion shipments by 2021 at ... , Research Analyst at ABI Research. "Surveillance is ...
Breaking Biology News(10 mins):