Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button

Home > Press > Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer

Abstract:
Keystone Nano, Inc., a biopharmaceutical company focused on improving cancer treatments through the application of nanotechnology, announced today that the U.S. Food and Drug Administration has approved the company's Investigational New Drug (IND) Application to assess Ceramide NanoLiposome in the treatment of solid tumors. The therapy will be tested in a Phase I clinical trial at three sites: the University of Maryland, the University of Virginia and the Medical University of South Carolina. The clinical trial will enable the Company to establish a safe dose level, and begin gathering information about the efficacy of the product as a cancer therapy.

Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer

State College, PA | Posted on January 10th, 2017

"This approval represents the conclusion of one phase of developing Ceramide, a truly novel anti-cancer agent, and the beginning of the very important human testing phase," noted Jeff Davidson, Keystone Nano's CEO. "We are excited by the efficacy and lack of toxicity Ceramide NanoLiposome has shown in preclinical testing, and we look forward to continuing to evaluate Ceramide NanoLiposome for human use. This is a significant step forward in the development of Ceramide NanoLiposome for the treatment of cancer."

Ceramide is a bioactive lipid that has shown efficacy in multiple models of liver cancer, as well as in breast cancer, leukemia and pancreatic cancer. Evidence collected in a large number of research tests (in vitro and in vivo) has clearly demonstrated that Ceramide NanoLiposome kills cancer cells while leaving normal cells alone, providing treatment without undue toxicity.

"The anti-cancer activity of Ceramide has long been known in the laboratory," said Dr. Mylisa Parette, Keystone Nano's Vice President of Research, "Until now, however, no-one has had an effective method for delivery of Ceramide, which is insoluble and has an extremely short half-life in the body. The proprietary formulation we are evaluating uses ceramide integrated into the membrane of a nanoliposome to overcome these barriers and allow us to exploit the novel properties of Ceramide as an anti-cancer therapy."

The Phase I portion of the trial will recruit patients with solid tumors to establish dosing and safety. The Phase II component of the trial is expected to focus on Liver Cancer, which kills approximately 27,000 people in the United States and 700,000 worldwide each year. There is currently no effective therapy for this disease. Keystone Nano was recently awarded orphan drug status for the treatment of liver cancer with ceramides in the United States. Keystone Nano previously announced that it was awarded a $2 million Phase II Small Business Innovation Research grant from the National Cancer Institute of the National Institutes of Health, which is funding part of this trial.

####

About Keystone Nano
Based in State College, PA, Keystone Nano is working at the interface between nanotechnology and the life sciences. In addition to developing Ceramide NanoLiposome, 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. In addition, Keystone has a 90 second animation that describes its technology at: https://www.youtube.com/watch?v=2rjcx4G0Vl0

For more information, please click here

Contacts:
Jeff Sirianni
Director of Marketing

Copyright © Keystone Nano

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.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Leti to Demo Wristband with Embedded Sensors to Diagnose Sleep Apnea: APNEAband, Which Will Be Demonstrated at CES 2018, Also Monitors Mountain Sickness, Dehydration, Dialysis Treatment Response and Epileptic Seizures December 12th, 2017

Leti Develops World’s First Micro-Coolers for CERN Particle Detectors: Leti Design, Fabrication and Packaging Expertise Extends to Very Large Scientific Instruments December 11th, 2017

Untangling DNA: Researchers filter the entropy out of nanopore measurements December 8th, 2017

Device makes power conversion more efficient: New design could dramatically cut energy waste in electric vehicles, data centers, and the power grid December 8th, 2017

Cancer

Researchers advance technique to detect ovarian cancer: Rice, MD Anderson use fluorescent carbon nanotube probes to achieve first in vivo success November 30th, 2017

Drug-delivering nanoparticles seek and destroy elusive cancer stem cells November 28th, 2017

Graphene oxide making any material suitable to create biosensors: Scientists from Tomsk Polytechnic University have developed a new tool for biomedical research focused on single-cell investigation November 27th, 2017

Tiny robots step closer to treating hard-to-reach parts of the body November 25th, 2017

Govt.-Legislation/Regulation/Funding/Policy

Wheat gets boost from purified nanotubes: Rice University toxicity study shows plant growth enhanced by -- but only by -- purified nanotubes December 6th, 2017

Arrowhead Presents New Clinical Data Demonstrating a Sustained Host Response in Hepatitis B Patients Following RNAi Therapy — Up to 5.0 log10 reduction in HBsAg observed; data presented at HEP DART 2017 — December 6th, 2017

Chinese market opens up for Carbodeon nanodiamonds: Carbodeon granted Chinese Patent for Nanodiamond-containing Thermoplastic Thermal Compounds December 4th, 2017

Researchers advance technique to detect ovarian cancer: Rice, MD Anderson use fluorescent carbon nanotube probes to achieve first in vivo success November 30th, 2017

Nanomedicine

Leti to Demo Wristband with Embedded Sensors to Diagnose Sleep Apnea: APNEAband, Which Will Be Demonstrated at CES 2018, Also Monitors Mountain Sickness, Dehydration, Dialysis Treatment Response and Epileptic Seizures December 12th, 2017

Untangling DNA: Researchers filter the entropy out of nanopore measurements December 8th, 2017

Arrowhead Presents New Clinical Data Demonstrating a Sustained Host Response in Hepatitis B Patients Following RNAi Therapy — Up to 5.0 log10 reduction in HBsAg observed; data presented at HEP DART 2017 — December 6th, 2017

Copper will replace toxic palladium and expensive platinum in the synthesis of medications: The effectiveness of copper nanoparticles as a catalyst has been proven December 5th, 2017

Announcements

Leti to Demo Wristband with Embedded Sensors to Diagnose Sleep Apnea: APNEAband, Which Will Be Demonstrated at CES 2018, Also Monitors Mountain Sickness, Dehydration, Dialysis Treatment Response and Epileptic Seizures December 12th, 2017

Leti Develops World’s First Micro-Coolers for CERN Particle Detectors: Leti Design, Fabrication and Packaging Expertise Extends to Very Large Scientific Instruments December 11th, 2017

Untangling DNA: Researchers filter the entropy out of nanopore measurements December 8th, 2017

Device makes power conversion more efficient: New design could dramatically cut energy waste in electric vehicles, data centers, and the power grid December 8th, 2017

Nanobiotechnology

Arrowhead Presents New Clinical Data Demonstrating a Sustained Host Response in Hepatitis B Patients Following RNAi Therapy — Up to 5.0 log10 reduction in HBsAg observed; data presented at HEP DART 2017 — December 6th, 2017

Going swimmingly: Biotemplates breakthrough paves way for cheaper nanobots: By using bacterial flagella as a template for silica, researchers have demonstrated an easier way to make propulsion systems for nanoscale swimming robots November 30th, 2017

Drug-delivering nanoparticles seek and destroy elusive cancer stem cells November 28th, 2017

Graphene oxide making any material suitable to create biosensors: Scientists from Tomsk Polytechnic University have developed a new tool for biomedical research focused on single-cell investigation November 27th, 2017

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project