Nanotechnology Now





Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > MonoSol Rx and Midatech Ltd Complete Transbuccal Insulin Delivery Study in Primate Diabetes Model

Abstract:
Proof-of-Concept for Oral Insulin Delivery Achieved in Key Species

Efforts Underway for Human Trials in 2011

MonoSol Rx and Midatech Ltd Complete Transbuccal Insulin Delivery Study in Primate Diabetes Model

Warren, NJ | Posted on January 4th, 2011

MonoSol Rx, the developer of PharmFilm® drug delivery technology, and Midatech Group Ltd, a global leader and centre of excellence for the design, development, synthesis and manufacture of nanomedicines, today announced positive results from a pre-clinical study of insulin PharmFilm, the first-ever oral insulin film formulation to transbuccally deliver an active therapeutic dose of insulin in a diet-induced diabetic primate model.

The two companies are developing insulin PharmFilm under a partnership that leverages MonoSol Rx's PharmFilm and Midatech's biocompatible nanoparticles to develop orally bioavailable formulations of peptides and drugs. This partnership includes a joint venture set up to focus on the development and commercialization of products combining the two companies' respective technologies in the diabetes field.

The transbuccal Pharmfilm delivery of insulin in this Rhesus monkey study represents the most advanced proof-of-concept to date for any investigative oral buccal insulin formulation, and confirms previously announced positive results in two porcine studies. Primates in the study were administered insulin PharmFilm transbuccally, or "inside the cheek," with data confirming delivery of an active therapeutic dose of insulin.

A spokesperson for MonoSol Rx said, "Diabetes is reaching near epidemic proportions globally. For the millions of patients worldwide who require insulin treatment, an easy-to-administer, orally dissolving insulin formulation that eliminates the need for injection could address the fear and stigma associated with daily insulin injections and may improve patient compliance. While several attempts have been made to orally deliver a therapeutic dose of insulin, insulin PharmFilm has overcome the higher development hurdle and delivered superior proof-of-concept results. Our transbuccal results in primate and porcine models demonstrate the therapeutic potential of our insulin PharmFilm formulation across different species, and we look forward to moving into man in 2011."

In addition to insulin PharmFilm, MonoSol Rx and Midatech are also evaluating additional peptides, including GLP-1, for oral buccal delivery. Based on positive results from the first GLP-1 porcine study, additional GLP-1 studies are being planned for 2011.

A spokesperson for Midatech Group stated, "The results of insulin PharmFilm in our primate study validate the film delivery of active insulin across the buccal mucosa for the first time. In addition, we have preclinical proof-of-concept that these results can be achieved in a controlled dose precisely tailored to suit individual needs. We anticipate results from our human clinical trials, slated to commence in the second quarter of 2011, to revolutionize treatment methods and insulin delivery for diabetics worldwide."

*PharmFilm is a registered trademark of MonoSol Rx.

####

About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence.

MonoSol Rx's commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.

About Midatech Ltd
Midatech Ltd, UK, is a world leader in the design, synthesis and manufacture of biocompatible nanoparticles. These nanoparticles can be used to create a wide variety of products with novel characteristics, functions and applications for a number of industry segments including life sciences, electronics and fine chemicals.

Founded in 2000, Midatech Ltd is a private company headquartered in Abingdon, Oxford, UK. In 2005, it registered its manufacturing facility – Midatech Biogune S.L. – in Bilbao, Spain, which became fully operational for cGMP standard design and manufacturing of API nanoparticles in March 2007. In 2008, Midatech Ltd further expanded with the opening of PharMida AG in Basel, Switzerland, which is responsible for clinical development of Midatech's products.

Midatech's biocompatible nanoparticles possess a number of unique properties that make them ideal for diagnostic and therapeutic applications. The nanoparticles are water dispersible and can be designed to diffuse freely in vivo, or to target specific cells. With a diameter of less than five nm, unbound nanoparticles are freely excreted by the kidneys, and thereby reduce the likelihood of non-specific in vivo accumulation. Their small size potentially enables drug delivery via different routes of administration, including parental, transdermal, mucosal, intradermal, transbuccal, sublingual or intranasal/inhalation. Furthermore, their high-degree of stability to enzymatic digestion makes them attractive for oral administration. The nanoparticles can be designed to evade detection by the host immune system by attaching multiple ligands to the nanoparticle surface, thereby allowing multivalent drug or multi-drug delivery on a single particle. Owing to the fact that the nanoparticles self-assemble in a single synthetic step, commercial manufacturing is simple, safe, scaleable and low cost.

Midatech Ltd has exclusive world-wide IP for the technology covering design, manufacture and application/use of nanoparticles in both diagnostic and therapeutic pharmaceutical areas as well as in other industries. It also has exclusive world-wide rights for technology relating to the synthesis and applications of self-assembling nanoparticles.

For further company information see www.midatechgroup.com

For more information, please click here

Contacts:
Midatech Group
Thomas Rademacher, Chief Executive Officer and Chairman,
Storme Moore-Thornicroft, Vice President, Corporate Management
Tel: +44 (0)1235 528022


Midatech Group (US)
Sterling C. Johnson
760-804-0114


MonoSol Rx
Keith Kendall, Executive Vice President
(732) 564-5000

College Hill Life Sciences (on behalf of Midatech Ltd)
Anastasios Koutsos, Nicole Yost
Tel: +44 (0)20 7866 7855


The Ruth Group (on behalf of MonoSol Rx)
Jason Rando (media)
Tel: +1 (646) 536-7025


Sara Pellegrino (investors)
Tel: +1 (646) 536-7002

Copyright © MonoSol Rx

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

Visible Light-Sensitive Photocatalysts Used for Purification of Contaminated Water in Iran June 30th, 2015

June 29th, 2015

Efforts to Use Smart Nanocarriers to Cure Leukemia Yield Promising Results June 29th, 2015

Making new materials with micro-explosions: ANU media release: Scientists have made exotic new materials by creating laser-induced micro-explosions in silicon, the common computer chip material June 29th, 2015

Possible Futures

Harris & Harris Group Portfolio Company D-Wave Systems Announces 1,000 Qubit Processor and is Discussed in the Economist June 23rd, 2015

Global Nanoclays Market Analysis, Size, Growth, Trends And Segment Forecasts, 2015 To 2022: Grand View Research, Inc June 15th, 2015

Healthcare Nanotechnology (Nanomedicine) Market Size To 2020 June 5th, 2015

Environmental Issues to Hamper Growth of Global Nanocomposites Market June 4th, 2015

Nanomedicine

Efforts to Use Smart Nanocarriers to Cure Leukemia Yield Promising Results June 29th, 2015

Chivalrous Knight Does Pro Bono June 27th, 2015

Green Chemistry Methods Used in Iran to Produce Zinc Oxide Nanoparticles June 27th, 2015

Targeted nanoparticles can overcome drug resistance in trypanosomes: A high-tech approach to combat sleeping sickness and potentially other neglected diseases June 26th, 2015

Announcements

Visible Light-Sensitive Photocatalysts Used for Purification of Contaminated Water in Iran June 30th, 2015

June 29th, 2015

Efforts to Use Smart Nanocarriers to Cure Leukemia Yield Promising Results June 29th, 2015

Making new materials with micro-explosions: ANU media release: Scientists have made exotic new materials by creating laser-induced micro-explosions in silicon, the common computer chip material June 29th, 2015

Nanobiotechnology

Nanometric sensor designed to detect herbicides can help diagnose multiple sclerosis June 23rd, 2015

Newly-Developed Biosensor in Iran Detects Cocaine Addiction June 23rd, 2015

Researchers first to show that Saharan silver ants can control electromagnetic waves over an extremely broad range of the electromagnetic spectrum—findings may lead to biologically inspired coatings for passive radiative cooling of objects June 19th, 2015

Cellulose from wood can be printed in 3-D June 17th, 2015

Research partnerships

June 29th, 2015

Graphene breakthrough as Bosch creates magnetic sensor 100 times more sensitive than silicon equivalent June 28th, 2015

The peaks and valleys of silicon: Team of USC Viterbi School of Engineering Researchers introduce new layered semiconducting materials as silicon alternative June 27th, 2015

Building a better semiconductor: Research led by Michigan State University could someday lead to the development of new and improved semiconductors June 27th, 2015

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