FRANKLIN, Mass., Oct. 12 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq: SONT) announced today results from two separate clinical
studies that evaluated the safety and feasibility of the transdermal delivery
of vaccines following ultrasonic skin permeation with the SonoPrep(R) device.
Sontra completed a 60-patient influenza vaccine study at St. Louis University
and a 15-patient Hepatitis A vaccine study at University of Massachusetts
Medical Center.
Influenza Vaccine Study -- St Louis University
Sixty adult volunteers were randomized into three groups and inoculated
with a standard tri-valent influenza vaccine delivered in one of three ways:
transdermal delivery through skin permeated ultrasonically with SonoPrep, via
intradermal injection or via traditional intramuscular injection. The
subjects' immune responses were evaluated thirty days after the inoculations
by analyzing blood titers (levels of antibodies in the blood).
Hepatitis A Vaccine Study -- University of Massachusetts Medical Center
Fifteen adult volunteers were randomized into two groups to compare
SonoPrep-enabled transdermal delivery of the Hepatitis A vaccine with
intradermal injection. All subjects received an initial inoculation and a
repeat "booster" inoculation after one month. Blood titers were collected at
one month (before the "booster") and again two months after the initial
inoculation.
In both of these studies there were no serious adverse events observed in
the SonoPrep treatment groups; however, the subjects that received the
vaccines through transdermal (SonoPrep treatment) delivery and intradermal
injection did not demonstrate the desired robust rise in protective titers,
presumably due to the limited bio-availability of the antigenic components of
the respective vaccines. Sontra is planning to conduct additional studies
with R&D partners designed to improve the immune response by incorporating
proprietary transdermal formulations, adjuvants and other technologies that
are expected to increase bio-availability.
"While we expected more encouraging results from our vaccine studies, we
are not surprised by the outcomes, because FDA-approved vaccines specifically
developed for intramuscular delivery were used in these studies," stated
Thomas W. Davison, PhD, Sontra's President and Chief Executive Officer. "As
part of our product development strategy, we first wanted to assess SonoPrep-
enabled transdermal delivery of existing FDA-approved vaccines because
regulatory approval could be achieved in a shorter time frame. With the
valuable knowledge gained from these studies, we will continue to develop
methods to optimize the delivery of vaccines through ultrasonically permeated
skin."
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a technology leader in transdermal science.
Sontra's SonoPrep ultrasound-mediated skin permeation technology combined with
technical competencies in transdermal drug formulation, delivery systems and
biosensors is creating a new paradigm in transdermal drug delivery and
diagnosis. The SonoPrep technology is being developed for several billion
dollar market opportunities, including continuous glucose monitoring and the
transdermal delivery of large molecule drugs and vaccines. Sontra is
currently marketing the SonoPrep device and procedure tray for use with
topical lidocaine to achieve rapid (within five minutes) skin anesthesia.
Contact:
Sean Moran, Chief Financial Officer
508-530-0334
SonoPrep is a registered trademark of Sontra Medical Corporation. All
other company, product or service names mentioned herein are the trademarks or
registered trademarks of their respective owners.
This press release contains forward-looking statements, which address a
variety of subjects including, for example, the expected benefits and efficacy
of the SonoPrep device in connection with diagnostics, vaccine delivery,
glucose monitoring and transdermal drug delivery, the expected market
opportunities, distribution and market acceptance of the SonoPrep device and
technology, Sontra's expected ability to form strategic partnerships and
commercialize additional products, including for the delivery of vaccines, and
Sontra's business, research, product development, regulatory approval,
marketing and distribution plans and strategies. Statements that are not
historical facts, including statements about our beliefs and expectations, are
forward-looking statements. Such statements are based on our current
expectations and are subject to a number of factors and uncertainties, which
could cause actual results to differ materially from those described in the
forward-looking statements. The following important factors and uncertainties,
among others, could cause actual results to differ materially from those
described in these forward-looking statements: adverse results in research
collaborations, product development, clinical trials, commercialization
efforts, product distribution and market acceptance; the SonoPrep device may
not prove effective in connection with diagnostics, vaccine delivery, glucose
monitoring and/or transdermal drug delivery; difficulties or delays in
obtaining regulatory approvals to market products resulting from development
efforts; difficulties or delays associated with sources of regulatory-approved
transdermal drugs and vaccines; failure to obtain and maintain patent
protection for discoveries; commercial limitations imposed by patents owned or
controlled by third parties; dependence upon strategic partners and third-
party distributors to develop, commercialize, market and sell products based
on our work; the commercial success of products; and the requirement for
substantial funding to conduct research and development and to expand
commercialization, distribution and marketing activities. For detailed
information about factors that could cause actual results to differ materially
from those described in the forward-looking statements, please refer to
Sontra's filings with the Securities and Exchange Commission, including
Sontra's most recent Quarterly Report on Form 10-QSB. Forward-looking
statements represent management's current expectations and are inherently
uncertain. We do not undertake any obligation to update forward-looking
statements made by us.
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, Chief Financial Officer of
Sontra, +1-508-530-0334
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