SCLN. New study shows their drug targets cancer cells. CEO says drug sales could reach $1 Billion. Russ
Wednesday March 1, 10:00 am Eastern Time
Company Press Release
SOURCE: SciClone Pharmaceuticals, Inc.
New Study Shows ZADAXIN's Dual Role in Immune Recognition of and Response To Cancer and Infection Mechanism of Action Study Published in European Journal of Immunology
SAN MATEO, Calif., March 1 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) announced today that a
study published in the peer-reviewed European Journal of Immunology (March 2000, Volume 30, Issue 3) shows that
ZADAXIN© (thymosin alpha 1) directly increases the immune system's ability to recognize and target cancerous and virally infected cells among healthy cells.
This new study complements a previous mechanism of action study, published in the International Journal of
Immunopharmacology (Vol. 21), in which ZADAXIN was shown to enhance the maturation of undifferentiated stem cells into
disease-fighting T-cells and to enhance the production of cell messengers that coordinate the complex immune response to disease.
In the currently published study, authored by researchers in Italy and at the U.S. National Institutes of Health (NIH) and National Cancer Institute (NCI), ZADAXIN promoted the production of major histocompatibility complex (MHC) class-1
molecules at the level of gene expression. MHC molecules are the key component of the immune system's method of `tagging' cells as either healthy or diseased. The effects were seen in multiple mouse and human cell lines as models for cancer and infectious diseases.
According to the article, whose lead author is Cartesio Favalli, Professor of Experimental Medicine and Biochemical Sciences at the University of Rome, ``MHC class-1 downregulation has been shown in many tumors and is considered an important factor in limiting immunotherapy of cancer. Thymosin alpha 1, by inducing MHC class-1 expression, could make tumor cells 'visible' to T lymphocytes and therefore less prone to escape from immune surveillance.'
``This finding may further contribute to explaining the activity of this peptide which, in view of our results, is not only exerted at the immune effector level but also at the target cell level,' concluded Professor Favalli in the published article.
``We now have the most complete picture to date of ZADAXIN's role in the immune system,' said Alfred R. Rudolph, M.D.,
SciClone's Chief Operating Officer. ``ZADAXIN not only promotes the maturation and differentiation of stem cells into disease-fighting T-cells and other immune weapons, but also makes the diseased cells themselves more visible targets for these weapons.'
``We know ZADAXIN works in hepatitis and cancers. Now, the further understanding of its mechanism of action points to
new therapeutic targets where MHC downregulation plays a key role in the disease process,' said Donald R. Sellers,
SciClone's President and Chief Executive Officer.
ZADAXIN currently is approved in Italy and 15 countries throughout Asia, Latin America, and the Middle East, principally as a single-agent therapy for hepatitis B, a combination therapy for hepatitis C or as an influenza vaccine adjuvant. SciClone has filed for ZADAXIN marketing approval in 19 additional countries. SciClone expects to start pivotal U.S. Phase 3 studies for hepatitis C during this year.
SciClone Pharmaceuticals is a global biopharmaceutical company that acquires, develops and commercializes
specialist-oriented drugs for treating chronic and life-threatening diseases, including hepatitis B, hepatitis C, cystic fibrosis, cancer and immune system disorders. SciClone's Common Stock is listed on the Nasdaq National Market under the symbol SCLN. Press releases and corporate information from SciClone Pharmaceuticals are available on the Internet at www.sciclone.com or by calling the Company's Investor Relations Department at 800-724-2566.
The information in this press release includes certain forward-looking statements concerning the Company's current
expectations regarding future events, including the ongoing and prospective development and commercialization of ZADAXIN
as a potential therapy for cancer and infectious diseases, future ZADAXIN marketing approvals and the commencement of
pivotal U.S. phase 3 studies for hepatitis C during 2000. Due to market factors and the nature of product development and the regulatory approval process, the forward-looking statements contained in this press release are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission.
SOURCE: SciClone Pharmaceuticals, Inc.
Wednesday February 23, 6:59 pm Eastern Time
SciClone says Zadaxin has strong sales potential
LAGUNA NIGUEL, Calif., Feb. 23 (Reuters) - SciClone Pharmaceuticals Inc. (NasdaqNM:SCLN - news) CEO Donald Sellers said the company plans to launch final-stage trials of its drug Zadaxin for the treatment of hepatitis C in the United States and Europe sometime this year.
Speaking at a conference on growth company stocks, Sellers said that annual sales of Zadaxin, an immunity-enhancing drug Sciclone now sells in 16 countries, may one day surpass $1 billion.
Fourth quarter 1999 sales of Zadaxin, an injectable drug used to treat hepatitis B, hepatitis C and cancer, totaled $3 million, he said.
The drug is now approved in Italy and 15 countries in Asia, Latin America and the Middle East. Sellers said SciClone did not originally have worldwide rights to the drug and began pursuing the other, larger, markets only after it became the global owner.
Zadaxin is composed of a synthetic version of a compound that occurs naturally in the body's immune system. ``We inject it into the body in a much higher concentration. It is very safe and it makes other drugs work better,' Sellers said, adding that clinical trials so far have shown no drug-related side effects or toxicity due to Zadaxin.
He noted that side effects caused by other drugs being used to treat a disease, such as chemotherapy for cancer, will still occur.
Sellers said the annual sales potential for Zadaxin is over $250 million in the U.S., $500 million in Japan and more than $1 billion worldwide.
The company expects a decision on a marketing application in Japan during 2003. |
