AROG's CP-868,596 Granted Orphan Drug Designation and Assigned the Generic Name Crenolanib

AROG Pharmaceuticals, LLC (“AROG”) is pleased to announce that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CP-868,596 for the treatment of glioma and assigned the generic name crenolanib.
By: Susan Do
 
Jan. 28, 2011 - PRLog -- Dallas, TX – January 28, 2011 – AROG Pharmaceuticals, LLC (“AROG”) is pleased to announce that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CP-868,596 for the treatment of glioma.  CP-868,596 is an orally bioavailable small molecule, highly potent, selective inhibitor of PDGFR kinase that targets malignant tumors.  AROG plans to initiate a Phase II trial with CP-868,596 for the treatment of adult gliomas and a Phase I/II trial with CP-868,596 for the treatment of pediatric gliomas in the first half of 2011.

“We are looking forward to aggressively developing CP-868,596 for the treatment of gliomas and other rare cancers,” said Vinay Jain, MD, Chief Executive Officer of AROG.  “The orphan drug designation is an important step forward to support the development of CP-868,596.”

According to the Orphan Drug Act of 1983, the orphan drug designation is granted to companies with products aimed at treating rare diseases or conditions that affects fewer than 200,000 Americans.  If the company’s product is granted the orphan drug status by the FDA, the company will be eligible to receive various financial incentives, including tax credits, access to grant funding for clinical trials, accelerated FDA review and marketing exclusively after drug approval for a period of as long as seven years.  

Crenolanib Designated as Generic Name for CP-868,596
AROG is also pleased to announce that the United States Adopted Name Council (USANC) and the World Health Organization’s INN program have adopted crenolanib as the generic name for CP-868,596. The USANC is tri-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA), and establishes drug nomenclature classifications based on pharmacological and/or chemical relationships.

About Crenolanib (CP-868,596)
Crenolanib is a potent and selective inhibitor of platelet derived growth factor receptors (PDGFR).  In April 2010, AROG signed an exclusive worldwide license with Pfizer for the development and commercialization of crenolanib. Phase I single agent and Phase Ib (combination with docetaxel and axitinib) clinical trials with crenolanib have been completed.

About AROG Pharmaceuticals, LLC
AROG is a private, oncology-focused drug development company based in Dallas, TX.  AROG’s mission is to develop novel anticancer drugs for the treatment of rare cancers with significant unmet medical need. To learn more about AROG, please visit www.arogpharma.com.
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Source:Susan Do
Email:***@arogpharma.com Email Verified
Zip:75251
Industry:Biotech
Location:Dallas - Texas - United States
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