BERKELEY HEIGHTS, NJ September 23, 2002
- Genta Incorporated (Nasdaq: GNTA) announced today the initiation
of a new clinical trial with its lead anticancer drug, Genasense
TM
, in patients with multiple myeloma. The study will assess the
safety and efficacy of Genasense
TM
in combination with thalidomide (Thalomid®; Celgene Inc.,)
and dexamethasone in patients who have failed standard therapy. The
trial will be conducted at the University of Maryland and is
sponsored by U.S. National Cancer Institute, pursuant to Genta's
Cooperative Research and Development Agreement (CRADA). Genasense
TM
works by inhibiting the production of Bcl-2, a protein made
by cancer cells that blocks chemotherapy-induced cell death. By
reducing the amount of Bcl-2 in cancer cells, Genasense
TM
may enhance the effectiveness of current anticancer
treatments. Recent preclinical data have shown that Bcl-2 is a
principal cause of chemotherapy resistance in myeloma cells, and
that pre-treatment of myeloma cells with Genasense
TM
greatly increases the effectiveness of dexamethasone, the
most commonly used drug for this disease. "Although high-dose
chemotherapy with stem-cell support has improved the outcome for
patients with multiple myeloma, few, if any, patients are actually
cured of the disease," commented Dr. Judith Karp, Associate
Director for Clinical Research, and Head of the Hematologic
Malignancy Program at the University of Maryland in Baltimore.
"Patients who relapse from standard approaches have a very poor
prognosis. The dexamethasone/thalidomide combination is widely
employed in the medical community, and we believe the inclusion of
Genasense
TM
may further optimize this regimen." "Genta is committed to
establishing a leadership role in the hematologic cancers. This
study represents our second clinical trial in patients with plasma
cell diseases, which includes the ongoing randomized trial in
myeloma," noted Dr. Loretta M. Itri, Genta's Executive
Vice-President and Chief Medical Officer. "This trial represents
part of our comprehensive program to document synergy with a wide
variety of anticancer agents."
About Multiple Myeloma
Multiple myeloma is a cancer of white blood cells that are
called plasma cells. In myeloma, these cells, which normally
produce infection-fighting antibodies, become mutated and then
multiply uncontrollably. This proliferation crowds out normal red
and white blood cells, leading to infections, bleeding and anemia.
The illness also decreases production of normal antibodies and
causes widespread destruction of bone that produces fractures, pain
and progressive disability. Myeloma is the second most common type
of hematologic cancer, just behind chronic lymphocytic leukemia
(CLL), which is also undergoing a randomized trial with Genasense
TM
plus chemotherapy. Recent statistics indicate that the
incidence of myeloma is increasing, while the median age of disease
onset is decreasing. About 11,200 people in the United States are
expected to die of this disease this year. Among African Americans,
multiple myeloma is one of the top 10 leading causes of cancer
death. More information about the disease is available through the
Multiple Myeloma Research Foundation:
http://www.multiplemyeloma.org/
Genta is currently conducting a randomized, multi-center trial
evaluating high-dose dexamethasone with or without Genasense
TM
in patients whom have relapsed from front-line therapy. For
patients with multiple myeloma and/or referring physicians whom
would like to learn more about this trial, including eligibility
and inclusion criteria, should call 1-888-TO-GENTA.
