906Bexxar: Coulter Initiates Expanded Access Program
- Sep 28, 1998Monday September 28, 8:01 am Eastern Time
Company Press Release
Coulter Pharmaceutical Initiates Expanded Access Program
PALO ALTO, Calif.--(BW HealthWire)--Sept. 28, 1998--Coulter Pharmaceutical
Inc. (Nasdaq:CLTR - news) today announced that the company has initiated
its Expanded Access Program for Bexxar(TM) (iodine I 131 tositumomab), the
company's lead cancer therapeutic in development for the treatment of
low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL).
The program was established by the company in response to requests from
physicians and patients for continued access to Bexxar during the period
prior to potential FDA marketing approval.
``We are pleased to be able to respond to patients with the rapid
initiation of our expanded access program,'' said Michael F. Bigham,
president and chief executive officer of Coulter Pharmaceutical. ``The
program will allow for the treatment of a broad patient population which
will include relapsed and refractory patients with low-grade or transformed
low-grade NHL who are seeking alternative therapy. In the process of
supplying Bexxar for the program, we will gain substantial
pre-commercialization experience in advance of potential marketing approval
of the product.''
The inclusion criteria for the expanded access program is broad, allowing
for the treatment of low-grade or transformed low-grade NHL patients who
have undergone at least one prior chemotherapy. The program will build
gradually and is expected to eventually include over 100 community and
academic oncology centers across the United States.
Bexxar, which is an antibody conjugated to iodine 131, attaches to a
protein found only on the surface of B-cells, including both non-Hodgkin's
lymphoma B-cells and some normal B-cells. It is believed that through this
targeted approach, the tumor cells receive a greater concentration of the
therapeutic radiation from Bexxar relative to normal tissues.
The antibody treatment is administered in a regimen which consists of two
intravenous doses given about one week apart -- first a dosimetric dose
followed by a therapeutic dose. This is in contrast to conventional
chemotherapy where treatment is given repeatedly over several months.
Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymph
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
270,000 people are afflicted with NHL in the United States alone. Of the
total, the company estimates that approximately 140,000 people have
low-grade or transformed low-grade disease. There are approximately 54,000
new cases of NHL diagnosed each year.
Coulter Pharmaceutical Inc. is engaged in the development of novel drugs
and therapies for the treatment of people with cancer. The company
currently is developing a family of cancer therapeutics based upon two drug
development programs: therapeutic antibodies and targeted oncologics.
The company's most advanced investigational product candidate is Bexxar(TM)
(iodine I 131 tositumomab), a monoclonal antibody conjugated to a
radioisotope. The company intends to file a BLA on Bexxar around year end
1998. Initial efforts in the targeted oncologics program are focused on the
development of a tumor-activated peptide pro-drug version of doxorubicin to
potentially treat certain solid tumor cancers.
Except for the historical information contained herein, the matters
discussed in this news release are forward-looking statements 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 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 annual report on Form 10-K for the year ended
December 31, 1997.
Coulter Pharmaceutical Sylvia Wheeler, 650/842-7306