Dermisonics, Inc.
Dermisonics’, Inc. Test With Type-2 Diabetics Proves Insulin Patch Component Of The U-Strip System Does Not Damage The Skin
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The issuer is solely responsible for the content of this announcement.
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Dermisonics’ Test With Type-2 Diabetics Proves Insulin Patch Component Of
The U-Strip System Does Not Damage The Skin
Represents Another Step Forward in Achieving FDA Approval
Irvine, California (USA) – September 25, 2006 – Dermisonics, Inc. (OTCBB:
DMSI; FWB:FQC), a developer of painless injection-free ultrasonic
transdermal drug-delivery patches and technologies with broad
pharmaceutical and consumer applications, announced today that it
successfully completed its HPT-3A human pilot trial of its proprietary
U-Strip transdermal drug-delivery system in patients with Type-2 diabetes,
demonstrating that an insulin-loaded proprietary patch does not cause skin
damage or irritation.
The Company continues its HPT-2 human pilot trial, an approved
investigational review board (IRB) study designed to demonstrate the
ability of the U-Strip System to deliver controlled doses of insulin to
patients, comparing the rate of delivery of insulin in comparison to an
insulin pump. The Company anticipates completion of HPT-2 by the end of
2006.
HPT-3A Study Goal – This trial specifically examined the effects of the
U-Strip insulin transdermal delivery system upon the skin of Type-2
diabetic patients. The goal of the study was to demonstrate that insulin
contained within the Company’s proprietary transdermal patch does not cause
skin damage or irritation.
HPT-3A Study Design – The study was conducted upon 25 adult Type-2 diabetic
patients of both sexes, with an average time on disease of at least 10
years. A U-Strip Low Profile Transdermal patch, containing 75 units of
insulin (enough for a two-day supply for most diabetics) was fitted on the
left upper arm and to the right side of the abdomen. The volunteers were
tested over a five-hour test period to determine any skin sensitivity to
the insulin or to the adhesive border of the patch. During this study no
ultrasound was applied. The patches were loaded with conventional insulin,
Humalog®, which was supplied by Eli Lilly Co. Abbott Laboratories supplied
the glucose meters, FreeStyle Flash®, which were used in the trial to
verify that the insulin was not permeating through the skin on its own. No
ultrasound was applied to the skin during this study, which tested the
irritancy of the insulin contact upon the skin and to a lesser degree the
border adhesive’s irritancy factor.
Results – The trial revealed no adverse skin reactions, no skin irritation
or skin damage among any of the volunteers. This study demonstrates that
the insulin-loaded patch component of the U-Strip system does not damage
the skin, even the skin of highly sensitive Type-2 diabetics. The contract
research organization that worked with the Company on the trial reported no
adverse reactions to the adhesive used in the insulin patches, but some
minor adhesive residue was observed around the border of the patch in some
of the volunteers. This reside was easily washed away and was not a source
for redness, discoloration or irritation.
Currently, people with diabetes rely on regular, frequent needle injections
of insulin to control blood glucose levels. Dermisonics’ proprietary
U-Strip system employs proprietary microelectronics and ultrasonic
technologies with a drug-carrying patch to enable the painless delivery of
large-molecule drugs through the skin’s natural pores and hair follicles.
This successful study, and the recently completed HPT-4 human pilot trial
that demonstrated that the ultrasound component of the U-Strip System did
not damage the skin of highly sensitive Type-2 diabetics, are significant
steps in achieving clinical approval for the U-Strip System.
About Dermisonics, Inc. – Dermisonics is an intellectual property company
and advanced technology incubator that is primarily focused on the ongoing
development, testing and eventual commercialization of a transdermal patch
that has been designed to facilitate the efficient and needle-free delivery
of drugs with large molecular structures into the bloodstream. Its
breakthrough system, called the U-Strip, is based on a radical integration
of microelectronics and ultrasonic science with a product-carrying patch,
and represents a quantum leap in non-invasive, transdermal delivery
technology. Company tests have shown that this system facilitates the
transdermal delivery of insulin and has the potential to deliver at least
175 other existing drugs that at present cannot be effectively delivered
through the pores of the skin using conventionally available transdermal
technology due to their large molecular size. For more information visit
http://www.Dermisonics.com.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934 that are based upon current expectations or beliefs,
as well as a number of assumptions about future events. Although the
Company believes that the expectations reflected in the forward-looking
statements and the assumptions upon which they are based are reasonable, it
can give no assurance that such expectations and assumptions will prove to
have been correct. The reader is cautioned not to put undue reliance on
these forward-looking statements, as these statements are subject to
numerous factors and uncertainties, including but not limited to adverse
economic conditions, intense competition, lack of meaningful research
results, entry of new competitors and products, adverse federal, state and
local government regulation, inadequate capital, unexpected costs and
operating deficits, increases in general and administrative costs,
termination of contracts or agreements, technological obsolescence of the
Company’s products, technical problems with the Company’s research and
products, price increases for supplies and components, litigation and
administrative proceedings involving the Company, the possible acquisition
of new businesses or that result in operating losses or that do not
perform as anticipated, unanticipated losses, the possible fluctuation and
volatility of the Company’s operating results, financial condition and
stock price, losses incurred in litigating and settling cases, dilution in
the Company’s ownership of its business, adverse publicity and news
coverage, inability to carry out research, development and
commercialization plans, loss of key executives and research scientists,
changes in interest rates, inflationary factors, and other specific risks.
In addition, other factors that could cause actual results to differ
materially are discussed in the Company’s most recent Form 10-QSB and Form
10-KSB filings with the Securities and Exchange Commission.
Contacts:
Dermisonics, Inc.
Bruce.Haglund@dermisonics.com
Raymond.Peterson@dermisonics.com
888-401-DERM (3376) Toll Free
Investor Relations Contacts:
International Market Trend
Toll-Free North America
1-877-676-4447
Michael Drepper
Phone: +49-621-430-6130
investor-germany@dermisonics.com
(c)DGAP 29.09.2006
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Language: English
Issuer: Dermisonics, Inc.
Dermisonics, Inc.
19428-2977 West Conshohocken, Pa. Vereinigte Staaten von Amerika
Phone: +1 610-941-2780
Fax: +1 610-941-2990
E-mail: bruce.haglund@dermisonics.com
WWW: dermisonics.com
ISIN: US24983U1043
WKN: A0DK4Y
Indices:
Listed: Freiverkehr in Berlin-Bremen; Open Market in Frankfurt
End of News DGAP News-Service
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