Maybe this answers how SKB really feels about Coulter and Bexxar.
Wednesday April 26, 8:04 am Eastern Time
Company Press Release
Coulter Pharmaceutical And SmithKline Beecham Combine Bexxar With CVP Chemotherapy in a New First-Line Clinical Trial
SOUTH SAN FRANCISCO, Calif./PHILADELPHIA--(BW HealthWire)--April 26, 2000--Coulter Pharmaceutical (Nasdaq:CLTR - news) and SmithKline Beecham (NYSE:SBH - news) today announced a Phase II multicenter investigational trial of Bexxar(TM) (tositumomab, iodine I 131 tositumomab) in combination with CVP, a commonly used chemotherapy regimen for the treatment of previously untreated low-grade non-Hodgkin's lymphoma (NHL). The companies have initiated this new combination trial to further investigate the first-line clinical use of Bexxar while simultaneously preparing a Biologics License Application (BLA) to the FDA for the marketing approval of Bexxar as a single agent in the treatment of relapsed or refractory, low-grade or transformed low-grade NHL.
``We believe that our single-agent data to date demonstrates the clinical potential of Bexxar,'' said Michael F. Bigham, president and chief executive officer of Coulter. ``By pursuing the clinical development of Bexxar in combination with chemotherapy, we hope to provide oncologists with safe and effective options in their therapeutic armamentarium to battle this devastating disease.''
The Phase II multicenter, open-label trial will include 30 previously untreated low-grade NHL patients who will receive six cycles of CVP (cyclophosphamide, vincristine, and prednisone) followed within 56 days by Bexxar. The primary endpoint of the trial is to determine overall response of the sequential combination.
In a separate first-line clinical trial in previously untreated low-grade NHL, Bexxar was evaluated in sequential combination with fludarabine, a chemotherapy approved for use in chronic lymphocytic leukemia and often used for the treatment of NHL. This single-center study is fully enrolled and is being conducted at the Center for Lymphoma and Myeloma at the Weill Medical College of Cornell University and New York-Presbyterian Hospital. Preliminary results from this study were presented in December 1999 at the American Society of Hematology. At the time of the presentation, 38 patients were enrolled of which 14 were evaluable for response. Following initial treatment with fludarabine, 14 percent of patients (two out of 14) experienced a complete remission. After subsequent treatment with Bexxar, 71 percent of patients (10 of 14) had experienced a complete response, a five-fold increase compared to initial treatment with fludarabine alone.
Treatment with fludarabine in combination with Bexxar was well tolerated. The principal side effects were hematologic, including a decrease in blood counts, which were reversible. Non-hematologic side effects experienced with Bexxar were mild to moderate, including nausea, fatigue, headache and rhinitis. In this study with fludarabine, only one patient developed human anti-mouse antibodies (HAMA).
Bexxar is a radioimmunotherapy involving an antibody conjugated to iodine 131 that attaches to a protein found only on the surface of B-cells, including non-Hodgkin's lymphoma B-cells. Bexxar is believed to work through multiple mechanisms of action resulting in immune system activity of the monoclonal antibody and the therapeutic effects of the iodine 131 radioisotope. Through the targeted approach of Bexxar, the tumor cells receive a greater concentration of the therapeutic radiation whereas the radiation to normal tissues is minimized.
Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymphatic tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. According to statistics from the National Cancer Institute, approximately 300,000 people are afflicted with NHL in the United States alone. It is estimated that approximately 140,000 people have low-grade or transformed low-grade disease.
Coulter Pharmaceutical, Inc. is engaged in the development of novel drugs and therapies for the treatment of cancer and autoimmune diseases. The company currently is developing a family of therapeutics based upon two drug development programs: therapeutic antibodies and targeted oncologics. The company's most advanced product candidate is Bexxar(TM), a monoclonal antibody conjugated to a radioisotope. The company's therapeutic antibodies program also includes an interferon receptor antagonist. Initial efforts in the targeted oncologics program are based on tumor activated prodrug (TAP) and tumor-specific targeting (TST) technologies. For more company information, visit Coulter Pharmaceutical's web site at coulterpharm.com.
SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at sb.com.
SmithKline Beecham Oncology is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products in oncology. Currently, SB Oncology markets Hycamtin© (topotecan hydrochloride), Kytril© (granisetron hydrochloride) and Compazine© (prochlorperazine), and has novel agents in development.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements for Coulter Pharmaceutical, Inc. that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of Bexxar(TM) or the company's other product candidates and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission (SEC). In particular, see ``Risk Factors'' in the company's filed Form 10-K for the year ended December 31, 1999.
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, SmithKline Beecham cautions investors that any forward-looking statements or projections made by the company, including those made in this news release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the company's operations are discussed in Exhibit 99 to the company's Annual Report on Form 20-F for 1999, filed with the U.S. Securities and Exchange Commission.
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Contact:
Coulter Pharmaceutical
Sylvia Wheeler, 650/553-2000
or
SmithKline Beecham
Jennifer Armstrong, 215/751-5664
Richard Williams, 215/751-7002
Jill Tannenbaum, 212/598-2847 |
