FOSTER CITY, CA -- 11/17/08 --
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that the Company and the U.S. Food and Drug
Administration (FDA) have reached agreement on the design of a phase 3
registration trial for thymalfasin as a potential treatment for stage IV
melanoma.
Based on the FDA's review, the agency agrees that the design and planned
analysis of SciClone's study adequately addresses the objectives necessary
to support a regulatory submission.
"Patients suffering from stage IV melanoma have very few treatment options
available. Based on the positive data from an earlier phase 2 trial,
thymalfasin could provide new treatment modalities for this high unmet
medical need," said Israel Rios, MD, SciClone's Chief Medical Officer. "The
FDA's acceptance of our phase 3 protocol for thymalfasin for the treatment
of stage IV melanoma, the most advanced form of skin cancer, is a critical
step in the advancement of this clinical program. We are now able to chart
the best course going forward, which may include bringing on a development
partner."
In June 2007, SciClone announced that its thymalfasin (ZADAXIN®, thymosin
alpha 1) achieved its primary endpoint in a phase 2 clinical trial treating
patients diagnosed with stage IV melanoma. Results showed that thymalfasin
in combination with dacarbazine (DTIC) chemotherapy tripled the overall
response rate and extended overall survival by nearly 3 months compared to
patients treated with DTIC, the current standard of care, combined with
interferon alpha.
The phase 2 multi-center, randomized open-label study enrolled 488 patients
with stage IV melanoma at 64 European clinical sites. The trial was
designed to evaluate different dose levels of thymalfasin in combination
with DTIC chemotherapy, with and without low-dose interferon alpha, as a
first-line treatment for stage IV melanoma. Most patients enrolled in the
trial had liver and other metastases and the remaining patients had lung
metastases and skin or lymph node metastases. Thymalfasin at all dose
levels was well-tolerated in all treated patients, with no serious adverse
events attributed to the drug. For more information on this phase 2 trial,
please refer to SciClone's press release dated June 4, 2007.
How Thymalfasin Works in Melanoma
Suppression of the growth of immune-sensitive tumors such as melanoma have
been shown to be dependent on a strong immune response, including a large
number of activated effectors such as tumor-infiltrating lymphocyte cells
(TILs) and specific anti-melanoma cytotoxic T lymphocytes (CTL). It is also
important to increase the presentation of cancer-specific antigens to the
immune system through sustained expression of these molecules along with
MHC Class I, as cancers avoid the immune system by decreases in this
presentation. Thymalfasin's potential beneficial role in treatment of
melanoma derives from its demonstrated activation of these various arms of
the immune system, including increases in TILs, CTLs, and expression of MHC
Class I and tumor-specific antigens. Thymalfasin's multiple activities
arise through activation of Toll-like receptor 9 and signaling through
increases in the nuclear factor NfKB through Myd88 and IKKb. Evaluation of
thymalfasin's utility in melanoma animal models has confirmed effective
anti-tumor activity.
About Melanoma
Skin cancer is the most common form of cancer in the United States. In
2008, the American Cancer Society estimates that approximately 8,420 deaths
will occur from melanoma and another 62,480 cases of melanoma are expected
to be diagnosed in this country. Melanoma is classified as stage IV, the
most advanced form, once the cancer has spread beyond the skin to a distant
site. DTIC and interleukin-2 (IL-2) are the only FDA-approved therapies for
the treatment of stage IV melanoma. However, neither of these therapeutic
agents nor alpha interferon, used alone or in combination, are effective at
extending overall patient survival, which at this stage is typically only
about six to nine months. Response to treatment largely depends upon the
stage of melanoma, disease site and the extent to which the cancer has
spread.
ZADAXIN received Orphan Drug designation in the United States for stage IIb
through stage IV melanoma in March 2006.
About SciClone
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) is a global biopharmaceutical
company dedicated to developing and commercializing promising therapies for
life-threatening diseases. SciClone's corporate infrastructure leverages
diverse global resources to finance growth in multiple markets and fund
development of its advanced pipeline of mid- to late-stage product
candidates. SciClone's lead product, ZADAXIN®, is approved for sale in
over 30 countries for the treatment of hepatitis B, hepatitis C, and
certain immune-sensitive cancers. According to SciClone's most recent
publicly-issued guidance, sales of ZADAXIN are expected to grow for the
full year 2008 by more than 40% compared to 2007, and are expected to reach
about $49 to $51 million in China alone. SciClone has several products in
clinical development, consisting of thymalfasin for stage IV melanoma,
RP101 for the treatment of pancreatic cancer, and SCV-07 for the treatment
of HCV and oral mucositis; and, awaiting approval in China, DC Bead(TM) for
the treatment of liver cancer. For additional information, please visit
www.sciclone.com.
The information in this press release contains forward-looking statements
including our expectations and beliefs regarding financial results for
2008, future sales and operations, and the timing and results of our
clinical trials. Words such as "expects," "plans," "believe," "may,"
"will," "anticipated," "intended" and variations of these words or similar
expressions are intended to identify forward-looking statements. In
addition, statements that refer to expectations, goals, projections or
other characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements. These statements
are not guarantees of future performance and are subject to risks,
uncertainties and assumptions that are difficult to predict and actual
results could differ materially and adversely. These risks include changes
in demand for and sales of ZADAXIN, the progress or failure of clinical
trials, our actual experience in executing on our objectives, the
performance of our partners, maintenance of the sufficiency and eligibility
of the enrolled patient population, unanticipated delays or additional
expenses incurred during our clinical trials, our future cash requirements,
delays in analyzing and synthesizing data obtained from clinical trials,
the performance and future actions of our strategic partners, unexpected
delays in clinical trial enrollment, future actions by the U.S. Food and
Drug Administration or equivalent regulatory authorities in Europe and the
fact that experimental data and clinical results derived from studies with
a limited group of patients may not be predictive of the results of larger
studies, as well as other risks and uncertainties described in SciClone's
filings with the Securities and Exchange Commission.
Corporate Contact:
Ana Kapor
SciClone Pharmaceuticals, Inc.
650.358.3437
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