Symbollon Pharmaceuticals Announces Results of IoGen Phase III Clinical Trial
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FRAMINGHAM, MA, Apr 10 (MARKET WIRE) --
Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) today announced the
results of a Phase III clinical trial designed to evaluate the effectiveness of
IoGen(TM) for the treatment of moderate to severe cyclic pain associated
with fibrocystic breast disease. In the study, patients were dosed once a
day for up to six months with either a 6-mg IoGen tablet or placebo. There
was no statistically significant difference between the treatment groups on the
primary endpoint of pain reduction. The findings demonstrated equivalence
between the active 6-mg IoGen formulation and the placebo in achieving the
primary efficacy endpoint. The data also showed no statistically significant
differencebetween the two groups in achieving the secondary efficacy endpoint of
fibrosis reduction. The overall incidence rates of treatment-related adverse
events,
serious adverse events or adverse events leading to discontinuation were
generally similar between treatment groups.
The study randomized 142 patients. Of this group, 61 patients were included
in the IoGen intent-to-treat group and 65 patients in the placebo
intent-to-treat
group. IoGen was clinically successful in achieving the primary efficacy
endpoint of pain reduction in 34 of 61 (56%) patients, compared to positive
responders in the placebo group of 38 of 65 (58%) patients. IoGen was
successful in achieving the secondary endpoint of at least 25% reduction of
fibrosis in 38 of 54 (71%) patients, compared to positive responders in the
placebo group of 39 of 61 (64%) patients.
"We are extremely surprised and disappointed by the high placebo results
inthis study," said Paul Desjourdy, President and CEO of Symbollon
Pharmaceuticals.
"While we will continue to evaluate the data, the results of this study will
severely limit our ability to proceed with the clinical development of IoGen.
Based on the Company's limited resources, management and the Board of Directors
will
be evaluating the Company's ability to continue operations. We have
adequate resources to continue operations through June. In light of these
clinical
results, it may be difficult for us to raise additional resources. Our focus
will be to maximize shareholder value by leveraging the Company's proprietary
technology."
About Symbollon Pharmaceuticals, Inc.: Symbollon (OTCBB: SYMBA) is a
specialty pharmaceutical company focused on the development and
commercialization of proprietary drugs based on its molecular iodine technology
for women's healthcare and antimicrobials uses. For more information about
Symbollon, please visit the company's website at http://www.symbollon.com.
Forward-Looking Statement: This news release contains statements by the
Company that involve risks and uncertainties and may constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. Such statements reflect management's current views and are based on
certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors, including, but not limited to,
the risks and uncertainties associated with whether (i) we will be able to
proceed with
the clinical development of IoGen, (ii) Symbollon will be able to obtain the
resourcesnecessary to continue operations as a going concern, (iii) Symbollon
will be
able to acquire the Chinese pharmaceutical company, Medpharm, (iv) the
Company will be able to enter into new arrangements with corporate partners, (v)
management and the Board of Directors will be able to maximize shareholder
value by leveraging the Company's proprietary technology, and (v) such other
factors
as may be disclosed from time-to-time in the Company's reports as filed with
the Securities and Exchange Commission.
CONTACT:
Paul C. Desjourdy
President and CEO
Symbollon Pharmaceuticals, Inc.
(508) 620-7676, x202
pauldesjourdy@symbollon.com
Kelly Black
Investor Relations
Premier Funding & FMS
(480) 649-8224
kblack@premierfundingservice.com
Copyright 2008, Market Wire, All rights reserved.
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