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SEATTLE, March 20, 2001 — Cell Therapeutics, Inc. (cti) (Nasdaq: CTIC) continues to advance the
investigation of TRISENOX(TM) (arsenic trioxide) injection in the treatment
of a variety of blood-related cancers.
Recently initiated studies include
first-line treatment of patients with acute promyelocytic leukemia (APL) and
treatment of patients with preleukemic syndromes called myelodysplasia
(MDS).
"This should be an exciting year in the development of
TRISENOX, with data being generated and presented throughout the year."
"There is a growing scientific basis for investigating TRISENOX in a variety
of blood-related cancers and strong interest among leading hematologists to
study TRISENOX in diseases such as leukemia, MDS, and multiple myeloma,"
stated James A. Bianco, M.D., President and CEO of cti. "Combined with the
ongoing studies conducted by the National Cancer Institute, there are more
than 20 clinical trials involving TRISENOX in over 10 different types and
stages of cancer. This should be an exciting year in the development of
TRISENOX, with data being generated and presented throughout the year."
Current first-line treatment for APL consists of ATRA (a vitamin A analog)
followed by anthracycline chemotherapy. In its pivotal trial, TRISENOX
resulted in a high rate of complete molecular remission among patients who
relapsed from or did not respond to ATRA and chemotherapy. The Phase IV
trial, conducted at M.D. Anderson Cancer Center in 40 patients, will
determine if TRISENOX administered along with ATRA can result in similar
high rates of remission without the side effects that accompany
anthracycline chemotherapy.
In addition to first-line treatment of APL,
TRISENOX is also being tested in patients with MDS. Up to 110 patients with
low risk and high risk MDS may be enrolled in this Phase II clinical trial.
TRISENOX, a pharmaceutical grade arsenic product, has been approved by the
Food and Drug Administration (FDA) to treat patients with relapsed or
refractory APL. In general, the toxicities associated with arsenic trioxide
therapy are well identified and manageable, when monitored and treated
appropriately.
APL is a life-threatening cancer of the blood that affects 10 percent to 15 percent of the
more than 10,000 patients who are diagnosed with acute myeloid leukemia each
year in the United States. TRISENOX was approved by the FDA in September
2000 based on a pivotal clinical trial of 40 patients with relapsed or
refractory APL who were unresponsive to or relapsed from standard therapies.
Seventy percent of these patients achieved a complete remission with 78%
achieving clearing of the molecular abnormality associated with APL.
An estimated 30,000 to 40,000 people in the United States suffer from MDS.
Approximately 40 percent of patients will die from the consequences of ineffective
blood cell production and 30 percent will progress to develop acute leukemia, a
form of cancer where too many white blood cells are made. Advanced stages of
the disease require treatment with chemotherapy and/or bone marrow
transplantation, which are ineffective in a majority of cases.
cti is committed to developing an integrated portfolio of oncology products
aimed at making cancer more treatable.
Source: Cell Therapeutics Inc.
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