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.
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.
####
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 Member
Monarch Solutions, LLC
Mobile: (703) 728.6837
www.Monarchsls.com
Copyright © Keystone Nano, Inc.
If you have a comment, please Contact us.Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.
Related Links |
Keystone has a 90 second animation that describes its technology at:
Related News Press |
News and information
Researchers develop artificial building blocks of life March 8th, 2024
Videos/Movies
New X-ray imaging technique to study the transient phases of quantum materials December 29th, 2022
Solvent study solves solar cell durability puzzle: Rice-led project could make perovskite cells ready for prime time September 23rd, 2022
Scientists prepare for the world’s smallest race: Nanocar Race II March 18th, 2022
Visualizing the invisible: New fluorescent DNA label reveals nanoscopic cancer features March 4th, 2022
Govt.-Legislation/Regulation/Funding/Policy
What heat can tell us about battery chemistry: using the Peltier effect to study lithium-ion cells March 8th, 2024
Researchers’ approach may protect quantum computers from attacks March 8th, 2024
Optically trapped quantum droplets of light can bind together to form macroscopic complexes March 8th, 2024
Possible Futures
Nanoscale CL thermometry with lanthanide-doped heavy-metal oxide in TEM March 8th, 2024
Nanomedicine
High-tech 'paint' could spare patients repeated surgeries March 8th, 2024
Researchers develop artificial building blocks of life March 8th, 2024
Announcements
What heat can tell us about battery chemistry: using the Peltier effect to study lithium-ion cells March 8th, 2024
Nanoscale CL thermometry with lanthanide-doped heavy-metal oxide in TEM March 8th, 2024
Nanobiotechnology
High-tech 'paint' could spare patients repeated surgeries March 8th, 2024
Researchers develop artificial building blocks of life March 8th, 2024
The latest news from around the world, FREE | ||
Premium Products | ||
Only the news you want to read!
Learn More |
||
Full-service, expert consulting
Learn More |
||