| Date | 19th, Sep 2019 |
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Home > Press > Keystone Nano Announces FDA Approval of Investigational New Drug Application for Ceraxa for the Treatment of Acute Myeloid Leukemia
Abstract: Keystone Nano, Inc., a biopharmaceutical company focused on improving cancer treatments through the application of novel treatments and nanotechnology, announced today that the U.S. Food and Drug Administration has approved the company�s Investigational New Drug (IND) Application to assess Ceraxa in the treatment of Acute Myeloid Leukemia (AML). This new approval leverages the company�s ongoing successful Ceraxa clinical trial by allowing the exploration of Ceraxa for cancer patients with AML.
State College, PA | Posted on September 18th, 2019
The company�s AML initial drug testing will be conducted at the University of Virginia and Memorial Sloan Kettering. The clinical trial will enable the Keystone Nano to test safety and efficacy of Ceraxa to establish a safe dose level and begin gathering information about the its benefits as a cancer therapy.
�This approval allows us to test our therapy for patients with AML�, noted Jeff Davidson, Keystone Nano�s CEO. �We are excited by the Phase I solid tumor study results to date and the lack of adverse events in clinical testing and evidence of patient benefit, and we look forward to continuing to evaluate Ceraxa for human use. This is a significant step forward in the development of Ceraxa for the treatment of AML.�.
Ceraxa is a bioactive lipid that has shown efficacy in AML as well as in breast cancer, liver cancer, and pancreatic cancer. Evidence collected in a large number of research tests and now in the clinic has clearly demonstrated that Ceraxa kills cancer cells while leaving normal cells alone, providing treatment without undue toxicity.
The Phase I portion of the AML trial will recruit patients with to establish dosing and safety. AML kills approximately 11,000 people in the United States. There are currently limited effective therapies for this disease and the five-year survival rate is approximately 27%. Keystone Nano was recently awarded orphan drug status for the treatment of AML with ceramides in the United States.
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About Keystone Nano, Inc.Based in State College, PA, Keystone Nano is working at the interface between nanotechnology and the life sciences. In addition to developing Ceraxa, the company is working on additional products using NanoJackets, calcium phosphate nanoparticles that may be targeted to specific cell types, for a variety of medical applications including RNA delivery and immuno-therapy. The Company�s product pipeline is protected by a patent portfolio comprised of 11 patent families that has resulted in 14 issued patents and 8 pending applications to date. More detail can be found at Keystone�s web site, including links to numerous published papers that describe Keystone�s technology and the results to date.
For more information, please click here
Contacts:Jeff Sirianni
Managing MemberMonarch Solutions, LLCMobile: (703) 728.6837www.Monarchsls.com
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