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TransPharma
Announces Successful Completion of a Phase 1b Clinical Trial of
ViaDor-GLP1 Agonist Indicated for the Treatment of Type II Diabetes
Study endpoints of pharmacokinetic profile, safety and tolerability successfully met
Lod, Israel, February 22, 2011 – TransPharma Medical Ltd., a
specialty pharmaceutical company focused on the development and
commercialization of drug products utilizing a proprietary active
transdermal drug delivery technology, announced today the successful
completion of a Phase 1b trial of ViaDor-GLP1 agonist, which is being
developed for the treatment of diabetes mellitus type II.
The
Phase 1b study was a single-dose, four-way cross over study designed to
evaluate the pharmacokinetic (PK) profile, safety and tolerability of
ViaDor-GLP1 agonist in diabetic patients using TransPharma's extended
release state-of-the-art film patch of GLP1 agonist. The study was
performed on 14 type II diabetic patients, and evaluated a once daily
application of three patch formulations, as compared to a twice daily
subcutaneous injection of Exenatide (Byetta).
The results of
the study demonstrate ViaDor-GLP1 agonist to be safe and well-tolerated
with a preferable extended PK profile compared to Exenatide (Byetta),
the injected GLP-1 agonist. Transdermal applications of ViaDor-GLP1
agonist resulted in therapeutic blood levels for approximately 20 hours
compared to 6 hours post injection of Exenatide. Concurrently, post
postprandial glucose levels were consistent with ViaDor-GLP1 extended
PK profiles.
GLP1 agonists/analogues
are a new class of medications for the treatment of type II diabetes
that offer improved glycemic control with no risk of hypoglycemia. The
first GLP1 agonist drug, Exenatide (Byetta), was approved in 2005, and
has already reached sales of over $670 million. Currently, these
drugs are administered once or twice daily to type II diabetes patients
via subcutaneous injections.
"In this Phase 1b study we have
shown that our modified GLP1 agonist film patch results in a
significantly extended PK profile with a similarly extended effect on
glucose levels in diabetic patients," said Dr. Daphna Heffetz, CEO of
TransPharma Medical. "We are also extremely pleased to announce that
the extended release film patch used in this study retains the same
size and design as our printed patch for immediate drug delivery, and
similarly has the potential for long shelf life at room temperature.
Our product may thus offer a safe, user-friendly and painless solution
for controlling blood glucose levels in people suffering from diabetes
mellitus type II."
About ViaDor Drug Delivery System
TransPharma’s
ViaDor drug delivery system incorporates a handheld electronic device,
which creates microscopic passageways through the outer layer of the
skin allowing for transdermal delivery of a wide variety of drugs from
a patch. The system provides a cost-effective, easy-to-use,
self-administered solution that enables the safe, reproducible and
accurate delivery of a broad range of product candidates, including
hydrophilic small molecules peptides and proteins.
About Diabetes Type II
Diabetes
type II, also known as adult onset diabetes, is a chronic disease
marked by high levels of glucose in the blood. Type II diabetes is the
most common form of diabetes, and is characterized by insulin
resistance. Long-term complications include increased risk of heart
attacks, strokes, amputation, and kidney failure. Diabetes was the
seventh leading cause of death in the USA in 2006. In 2008, in the U.S.
alone, diabetes affected 24 million people, which amounts to
approximately 8% of the population. The world wide diabetes market in
2008 was estimated at over $25 billion.
About TransPharma Medical
Established
in 2000, TransPharma Medical Ltd. is a specialty pharmaceutical company
focused on the development and commercialization of drug products
utilizing its proprietary active transdermal drug delivery technology.
The company aims to develop multiple drug products through strategic
partnerships with leading pharmaceutical companies and through
independent product development. Transpharma currently has 3 drug
products in clinical trials: ViaDor-hPTH (1-34) product for the
treatment of osteoporosis developed in collaboration with Eli
Lilly currently in Phase 2b clinical studies; ViaDor-GLP1 agonist for
the treatment of type II diabetes has completed phase 1b testing and
the ViaDor-Calcitonin for the treatment of musculoskeletal disorders
completed phase 1 clinical trials. For more information, please
visit the Company's website at www.transpharma-medical.com.
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©
TransPharma Medical™ Ltd. All Rights Reserved.
updated Dec 2008
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