SonoPrep Ultrasonic Skin Permeation Device Facilitates Delivery of Antigenic
Proteins
FRANKLIN, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today promising initial human clinical
results from a twenty patient study conducted by Daniel H. Libraty, M.D. at
the University of Massachusetts Medical School that evaluated the immune
response induced by using the SonoPrep skin permeation device to facilitate
the transdermal delivery of the antigenic proteins, tetanus toxoid and candida
albicans (yeast).
In this study, ten patients in the treatment group first received a fast
(10-30 seconds) SonoPrep skin pretreatment on their forearm creating an
imperceptible window for drug delivery through the skin. Then the antigenic
proteins, tetanus toxoid and candida albicans were applied topically to the
treated skin sites. A ten-patient control group received the standard
intradermal injection of the same antigenic proteins. The immune responses
induced by these antigenic proteins were evaluated by measuring the extent and
duration of the skin reaction, known at the delayed-type hypersensitivity
response (DTH). A DTH skin immune response was induced in 90% of the SonoPrep
treated patients and the duration of the DTH skin reaction was similar in the
treatment group versus the control group. "I think this is an innovative
technology with interesting potential in vaccinology and modulation of immune
responses to infectious pathogens" stated Dr. Libraty, an Assistant Professor
of Medicine at the Center for Infectious Disease and Vaccine Research at the
University of Massachusetts Medical School in Worcester.
Following the completion of this first study, Sontra had initially planned
to complete a second human study at the University of Massachusetts Medical
School using SonoPrep to facilitate the transdermal delivery of an influenza
vaccine. Due to the current shortage of flu vaccines and concern by public
health officials, Sontra has decided to donate its existing supply of flu
vaccine to the medical school's clinical partner, UMass Memorial Health Care
and will instead commence a second vaccine study later this fall with a
hepatitis A vaccine.
"We are very pleased with the promising results from our first transdermal
vaccination study" stated Shikha Barman, PhD, Director of Transdermal Drug
Development at Sontra. "We believe that our SonoPrep skin permeation
technology can facilitate transdermal vaccination and improve clinical
outcomes. Because SonoPrep controls the actual permeability of the skin
surface, antigens can be precisely delivered and a powerful immune response
can be induced by activating the Langerhan cells in the epidermis. To date the
majority of vaccines are delivered by needle injection. Not only does SonoPrep
have the potential to improve the efficacy of vaccines, transdermal vaccines
also eliminate the risk of inadvertent needle generated disease transmission
and patients always prefer pain-free therapy."
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a leading developer of transdermal drug
delivery and diagnostic products that combine Sontra's SonoPrep ultrasound-
mediated skin permeation technology with synergistic biosensor and transdermal
drug delivery technologies. Sontra is marketing the SonoPrep device and
procedure tray for use with topical lidocaine to achieve rapid (within five
minutes) skin anesthesia. Products under development include: a continuous
non-invasive glucose monitor developed in collaboration with Bayer Diagnostics
and the use of SonoPrep for the transdermal delivery of vaccines, pain drugs
and large protein biopharmaceuticals.
About UMASS Medical School (http://www.umassmed.edu)
The University of Massachusetts Medical School is one of the fastest
growing academic health centers in the country and has built a reputation as a
world-class research institution, consistently producing noteworthy advances
in clinical and basic research. The Medical School attracts more than $154
million in research funding annually, 80 percent of which comes from federal
funding sources. Research funding enables UMMS scientists to explore human
disease from the molecular level to large-scale clinical trials. Basic and
clinical research leads to new approaches for diagnosis, treatment and
prevention of disease.
This press release contains forward-looking statements, which address a
variety of subjects including, for example, the expected efficacy of the
SonoPrep device in connection with vaccine delivery, the expected benefits,
market opportunities and market acceptance of the SonoPrep device and
technology, the expected size of the markets for the SonoPrep device and
technology, and Sontra's business, research and marketing 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 product development, clinical trials, commercialization efforts and
market acceptance; difficulties or delays in obtaining regulatory approvals to
market products resulting from development efforts; difficulties or delays
associated with sources of transdermal drugs; 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 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.
Contacts:
Sean Moran, CFO
Sontra Medical Corporation
Tel: 508-553-8850
Evan Smith, CFA / Erica Pettit
KCSA Worldwide
Tel: 212-896-1251 / 212-896-1248
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, CFO of Sontra Medical
Corporation, +1-508-553-8850; Evan Smith, CFA, +1-212-896-1251,
or Erica Pettit, +1-212-896-1248, both of KCSA Worldwide
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