Navigation Links
Polaris Group Files New IND for ADI-PEG 20 in Leukemia
Date:12/2/2013

SAN DIEGO, Dec. 2, 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 acute myeloid leukemia. The FDA has reviewed this 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 already in a global Phase 3 study.

"This is another IND that expands the portfolio of indications for which ADI-PEG 20 is under development to hematologic malignancies," said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris Group. "Studies in leukemia and lymphoma will expand the studies currently underway with ADI-PEG 20, in addition to the solid tumors already under study. ADI-PEG 20 has a novel mechanism of action and well documented tolerability that we believe makes ADI-PEG 20 an ideal candidate both as monotherapy and 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 medicine technology :

1. Polaris Group Announces Treatment of First Patient in Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia
2. Polaris Group Lead Therapeutic Candidate ADI-PEG 20 Demonstrates Potential Anticancer Activity in Various Metastatic Sarcomas and Bladder Cancers That Are Deficient in Key Metabolic Protein, and Enhanced Effects with Combination Therapy in Melanoma
3. Millennium HealthCare Inc. Installs VasoScan Cardiovascular Assessment Test in Select Physician Groups during First Week of Launch
4. The Huntzinger Management Group, Inc. (HMG) Reporting Significant Growth and Business Expansion in 2013
5. Jean Coutu Group chooses Microsoft Dynamics for Retail to streamline operations
6. Life Care Solutions Group: The #Vaginal Mesh Debacle Is More Complicated Then The Hip Settlement
7. Implantable Medical Device Group formed to Reduce Risk and Simplify Management of Active Implant Projects
8. Simcere Pharmaceutical Group Announces Extraordinary General Meeting of Shareholders
9. HyGreen, Inc. Signs Distribution Agreement with Unison Group
10. Simcere Pharmaceutical Group Reports Preliminary Unaudited Third Quarter 2013 Results
11. Triangle Insights Group Opens RTP Office
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... 2016  ValGenesis, Inc., the market leader ... today announced that a prominent world provider ... chronic kidney failure has selected ValGenesis Validation ... validation process. The global medical device manufacturer ... manage their validation processes electronically. Upon completion ...
(Date:4/27/2016)... April 27, 2016  Hologic, Inc. (Nasdaq: ... results for the fiscal second quarter ended March ... of $0.24 increased 41.2%, and non-GAAP diluted EPS ... increased 5.8% on a reported basis, and 6.3% ... "We posted another good quarter, highlighted by 14.6% ...
(Date:4/27/2016)... , April 27, 2016 ... Including 42% Growth in Recurring Consumable Sales  ... Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor ... announced its sales for the first quarter ended March ... and the execution of its commercial strategy. ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... 2016 , ... The American Society for Aesthetic Plastic Surgery ... AnzuMedical™ Knowledge Sharing and Collaboration Platform™ , today announced a joint initiative ... to launch in July 2016 and will be a combined effort between ASAPS, ...
(Date:4/28/2016)... ... 28, 2016 , ... A first-time look at workers’ compensation claims in Kentucky ... Workers Compensation Research Institute (WCRI) announced, and that costs per claim were stable ... 16th Edition , found that indemnity costs per claim and benefit delivery expenses per ...
(Date:4/28/2016)... ... 2016 , ... Metabolic Nutrition today announced the upcoming launch of ... Games Get Fit and Sports Expo in Orlando, Florida. Attended by pro ... April 29-30, was selected as the perfect event to introduce the highly anticipated GlycoLoad. ...
(Date:4/28/2016)... ... 28, 2016 , ... Denise McCormick Baich had written poetry dating back to her childhood, but ... like a tsunami and took on a more spiritual tone. The desire to put the ... more with it than just file it away. Friends would ask her how she wrote ...
(Date:4/28/2016)... Hollywood, CA (PRWEB) , ... April 28, 2016 , ... ... emergency dental care as soon as possible is essential when it comes to dental ... may make the difference between saving and losing a tooth. Toothaches, knocked-out teeth, chipped ...
Breaking Medicine News(10 mins):