Midatech and MonoSol Rx Announce Positive Phase 1 Clinical Results for Their Novel Transbuccal Oral Insulin Film Product
OXFORD, England and WARREN, N.J., May 3, 2012 (GLOBE NEWSWIRE)
-- Midatech Ltd., a global leader in the design, synthesis and
manufacture of nanomedicines based on its passivated
gold-nanoparticle technology, and MonoSol Rx LLC, the developer of
PharmFilm(R) drug delivery technology, today announced positive
bioavailability and pharmacokinetic results from a first-in-human
Phase 1 clinical study of their Midaform(TM) Insulin PharmFilm
product in 27 healthy volunteers.
The companies have licensed to their joint venture company, MidaSol
Therapeutics LLC, a proprietary nanoformulated transbuccal insulin
film product, which delivers monomeric insulin through the use of a
rapidly dissolving mucoadhesive film that is placed onto the inside
of the cheek.
Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol's product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Buhler, Chief Medical Officer and member of the Board of Midatech Ltd.
A. Mark Schobel, Co-President and CEO of MonoSol Rx, said "These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics following administration of Midaform Insulin Pharmfilm. The rapid onset of action surpassed our expectations and we look forward to further clinical development of this exciting and new groundbreaking product. Based on the success of this in-man study, which unequivocally validates the utility of our diverse pre-clinical animal models, we look forward to accelerating the entire product development program."
Professor Thomas Rademacher, CEO and Chairman of Midatech,
remarked:
"The success of Midaform Insulin PharmFilm demonstrates its safety,
tolerability and potential use in treating diabetes, particularly
meal-dependent hyperglycemia. This study is a significant step
forward for the commercialization of this novel, non-injectable
insulin formulation. This trial shows the success of the MidaSol
Therapeutics LLC joint venture between Midatech and MonoSol, and
brings us closer to using nanomedicines in clinical practice."
About Diabetes
Diabetes is a disease associated with high levels of blood
glucose resulting from defects in insulin production, insulin
action, or both.
It is the seventh leading cause of death in the United States and
can cause serious health complications including heart disease,
blindness, kidney failure, and lower-extremity amputations.
According to the Centers for Disease Control, nearly 24 million
people in the United States are currently living with diabetes.
Globally, more than 230 million people are living with the disease
and this number is expected to rise to 350 million within 20
years.
About MidaSol Therapeutics LLC.
MidaSol Therapeutics LLC. is a joint venture formed by Midatech
Ltd. of Oxford, England and MonoSol Rx LLC of Warren, New Jersey.
The JV company is dedicated to the development of new products for
the treatment of diabetes, including existing therapeutics such as
insulin and GLP-1, as well as new molecules. The JV utilizes
proprietary technology of the parents in the fields of
nanoparticles sourced from Midatech (Midaform(TM) ) and film
technology from MonoSol Rx
(PharmFilm(R) ) . All partnering for development and
commercialization in the field of diabetes will be through MidaSol
Therapeutics LLC, which is being advised by Ferghana Partners, a
specialist investment bank in the biotech field.
About Midatech Ltd.
Midatech Ltd., UK, is a world leader in the design, synthesis and manufacture of glycan-coated biocompatible gold-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 soluble and can be designed to
either diffuse freely in vivo, or to target specific cells. With a
diameter of less than 5nm, unbound nanoparticles are freely
excreted from the kidneys, reducing the likelihood of non-specific
in vivo accumulation.
Their size potentially enables drug delivery via different routes
of administration, such as parental, transdermal, mucosal,
intradermal transbuccal, sublingual or intranasal/inhalation. Their
stability to enzymatic digestion may also permit oral therapy.
Nanoparticles can be designed to be invisible to the host immune
system with multiple ligands attached to a single nanoparticle
allowing multivalent drug or multi-drug delivery on a single
particle. In addition, as the nanoparticles self-assemble in a
single step chemical process manufacturing is simple, safe,
scalable 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
About MonoSol Rx LLC
MonoSol Rx is a specialty pharmaceutical company leveraging its
proprietary PharmFilm(R) technology to deliver drugs in
films.
PharmFilm(R) 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 drug products, a pipeline of prescription formulations
based on PharmFilm(R) technology, and two recent FDA approvals -
Zuplenz(R), the first approved prescription oral soluble film for
the prevention of chemotherapy-induced, radiotherapy-induced, and
postoperative nausea and vomiting, and Suboxone(R) sublingual film,
the first combination sublingual film product for the treatment of
opioid dependence.
For press releases and other company information visit www.monosolrx.com
CONTACT: Midatech Ltd.
Thomas Rademacher, Chief Executive Officer and Chairman
Storme Moore-Thornicroft, Vice President, Corporate
Management
Tel: +44 (0)1235 528022
info@midatechgroup.com
MonoSol Rx
Mark Schobel, Co-President, CEO and CTO
Keith Kendall, Co-President, CFO and COO
Tel: +1 (908) 941-1906
Ferghana Partners
William J. Kridel, Jr., Managing Partner
Tel: +1 (917) 531-5851
College Hill Life Sciences (on behalf of Midatech Ltd.)
Anastasios Koutsos, Nicole Yost
Tel: +44 (0)20 7866 7856
midatech@collegehill.com
The Ruth Group (on behalf of MonoSol Rx)
Victoria Aguiar (media)
Tel: +1 (646) 536-7013
vaguiar@theruthgroup.com
Joshua Drumm, PhD (investors)
Tel: +1 (646) 536-7006
jdrumm@theruthgroup.com
Posted: May 2012
