FOR IMMEDIATE RELEASE
SYMBOLLON ANNOUNCES FAVORABLE PHASE II TRIAL RESULTS FOR IOGEN
Contacts:
Symbollon: Paul C. Desjourdy Investors: Tim Curtiss
President/COO Wall Street Investor Relations
(508) 620-7676, x12 (877) 925-5784
FRAMINGHAM, MASSACHUSETTS, August 16, 2000 -- Symbollon Corporation
(NASDAQ:SYMBA) today announced favorable preliminary results of a Phase II
clinical trial for its patented drug, IoGen(TM). IoGen is being developed as a
treatment for fibrocystic breast disease (FBD).
"The objective of our Phase II trial was to investigate IoGen's safety and
efficacy at various dosage levels," said Jack H. Kessler, Ph.D., Chairman, CEO
and Chief Scientific Officer of Symbollon. "We are pleased to report that the
preliminary results of our trial are positive and statistically significant. We
now need to replicate these results in larger-scale phase III trials."
"The successful completion of this proof-of-concept study is an important
landmark in the life of Symbollon," added Dr. Kessler. "IoGen addresses a
significant unmet need for over 24 million women in the United States, and many
more worldwide. Over 5 million American women have sought treatment for
fibrocystic breast disease. The beneficial effects seen in the Phase II study,
along with the excellent safety profile, mandate the continued development of
IoGen. We are committed to pursuing the commercialization of this drug."
"Previous medical research has demonstrated that therapeutically administered
molecular iodine can successfully treat FBD. Unfortunately, due to the
difficulty of formulating molecular iodine, this treatment has not been made
available to women. Our preliminary Phase II results, which follow favorable
Phase I results and stability data, indicate that IoGen has the potential to
help women who suffer from FBD," he concluded.
Paul C. Desjourdy, President and COO of Symbollon, stated, "Our decision to
invest in IoGen was based on its tremendous market opportunity. Our priority is
to complete its clinical development and move toward a Food and Drug
Administration (FDA) approval. In the coming months, we plan to meet with the
FDA to review the data and the design of the Phase III pivotal trials for
IoGen."
Mr. Desjourdy also noted that, "Another important element of our plan is to
initiate efforts to expand awareness and education for managing FBD. We are
seeking cooperation from the medical community and professional and consumer
organizations, both to promote improved breast care management and to impact
early detection of breast cancer."
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The multi-center Phase II clinical trial treated over 100 patients with moderate
to severe FBD in a placebo-controlled, double-blinded, randomized study. Three
drug concentrations, 1.5 mg, 3.0 mg and 6.0 mg, were dosed daily for six months,
followed by a two-month observation period.
In the Phase II trial, IoGen was well tolerated by the patients. There were also
no drug-related serious adverse events.
The Company's definition of clinical success for IoGen in the Phase II trial is
based on the same assessment tools that were used to evaluate the only
FDA-approved drug to treat FBD, danazol. The primary variables assessed were
breast pain, breast tenderness and nodularity. IoGen patients were scored a
success only if improvement was observed in all three measures. Danazol's
criteria for success only required improvement in nodularity, with no worsening
in the other two symptoms.
111 patients were randomized. This group included 80 patients who competed the
Phase II trial with symptoms at baseline, and therefore could be successfully
treated under Symbollon's definition of clinical success. For the 80 patients
who completed the trial, IoGen was clinically successful in 7 of 28 (25%)
patients in the 3.0-mg group and 5 of 27 (20%) patients in the 6.0-mg group,
compared to no positive responders in the placebo (n=15) and 1.5 mg (n=10)
groups. Additionally, for these 80 patients, there was a statistically
significant association between dose and response (p=0.047).
For the entire 111 patients randomized, IoGen was clinically successful in 7 of
38 (18%) patients in the 3.0-mg group and 5 of 40 (13%) patients in the 6.0-mg
group, compared to no positive responders in the placebo (n=17) and 1.5 mg
(n=16) groups. When the 3 and 6 mg groups of randomized patients are combined,
the results were statistically significant (p= 0.016), when compared to the
placebo and 1.5 mg groups combined.
Further supporting the positive findings are the preliminary results of a
validated, health-related quality of life questionnaire. The questionnaire was
developed by the Lewin Group for women with FBD, who were treated with iodine.
Seven FBD symptom scales were analyzed. Statistically significant differences
were achieved between the placebo and IoGen groups (as a whole) for four of
these FBD symptom-related outcomes at p<0.05 and one at p<0.020.
In connection with this announcement, Symbollon will host a conference call for
investors and other interested parties. The call will take place at 11:00 AM EDT
on August 16th. Participants can dial 800/923-4216 and request to be connected
to the Symbollon conference call. International callers should dial
904/779-4715. To ensure a prompt start to the call, participants are requested
to connect to the call 10 minutes before the scheduled start. A replay of the
call will be available until midnight on August 18th. The replay will be
available at 800/252-6030. The access code for the replay is 6762680.
Symbollon Corporation is engaged in development of proprietary iodine-based
compounds for the prevention and treatment of various human diseases. The
Company's development efforts are currently focused on fibrocystic breast
disease, ophthalmology and dermatology.
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. For example, the
Company's analysis of clinical results is ongoing, and future analyses may not
necessarily support conclusions to date. 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, such factors as may be disclosed from
time-to-time in the Company's reports as filed with the Securities and Exchange
Commission. Given these uncertainties, current or prospective investors are
cautioned not to place undue reliance on any such forward-looking statements.
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