Genta Provides Clinical and Regulatory Update on Its Lead Anticancer Compound, Genasense(TM), at JP Morgan H&Q Conference
SAN FRANCISCO, Jan 7, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta
Incorporated (Nasdaq: GNTA) presented a clinical and regulatory update on its
lead oncology product, Genasense(TM) (oblimersen sodium). Genasense is being
evaluated in collaboration with Aventis (NYSE: AVE) in randomized clinical
trials for its ability to maximize the effectiveness of chemotherapy in patients
with cancer. The information was provided yesterday in an invited address by the
Company's Chief Executive Officer, Dr. Raymond P. Warrell, Jr., at the JP Morgan
H&Q Conference in San Francisco, CA.
In his remarks, Dr. Warrell noted: "I am pleased to announce that the target
enrollment in the randomized trial of Genasense(TM) in multiple myeloma has been
achieved. We are also in the process of winding up enrollment in the randomized
trial in patients with malignant melanoma. To date, 720 of the planned 750
patients have been enrolled, and we expect that this trial will close later this
month. As of this week, the trial in patients with advanced chronic lymphocytic
leukemia (CLL) will have enrolled more than 75% of its 200-patient goal, and we
expect to hit that target later this quarter."
"Assuming data from one or more of these trials is positive, we remain
comfortable with the Company's principal goal of submitting a New Drug
Application for Genasense in the summer of this year. The slightly longer time
to complete the accrual in the CLL study is not currently expected to effect
that timeline, largely because the primary end-point in that trial is tumor
response, which tends to occur quickly in CLL, rather than survival or
time-to-progression, as in the melanoma and myeloma trials, respectively."
Dr. Warrell concluded his remarks by noting: "Collectively, these milestones
represent a tremendous achievement by the employees of Genta. The management of
our extensive clinical trials program is a tribute to their extraordinary
experience, diligence and dedication. Similarly we could not have achieved these
goals without the critical contributions of patients who joined these trials, as
well as the enthusiasm of the oncology investigators with whom we work."
The webcast of Dr. Warrell's presentation can be accessed through Genta's
investor site at: genta.com. Replays will be
available for 30 days following the presentation.
About the Genasense Randomized Trials Programs
The randomized trial in advanced melanoma includes patients who have not
previously received chemotherapy. This 750-patient study is designed to compare
survival of patients treated with chemotherapy alone versus chemotherapy plus
Genasense. The randomized trials in multiple myeloma and CLL are being conducted
in patients who have relapsed after standard therapy. Each of these 200-patient
studies is testing whether the addition of Genasense to standard chemotherapy is
superior to chemotherapy used alone. Genasense has received Orphan Drug
designation by the Food and Drug Administration (FDA) for each of these three
indications; the drug has also received Fast Track designation for melanoma and
myeloma.
About Melanoma
Melanoma is the most serious type of skin cancer and accounts for almost all of
the mortality in that condition. In Western countries, the number of people who
develop melanoma is increasing faster than any other cancer. Since 1973, the
annual incidence of melanoma in the U.S. has more than doubled from 5.7 to 14.3
per 100,000 people. The American Cancer Society estimates that about 53,600 new
melanomas were diagnosed in the U.S. last year.
About Multiple Myeloma
Multiple myeloma is a cancer that arises in blood cells (called plasma cells)
that normally reside in the bone marrow. Plasma cells are important because they
normally produce antibodies that fight off infections. When cancer develops in
plasma cells, these cells markedly increase in number, which can cause severe
bone pain and fractures; however, the ability of these cells to produce
antibodies is actually greatly reduced. Therefore, people with these conditions
are highly susceptible to infections. Malignant plasma cells are known to
contain a high amount of Bcl-2 protein, which is targeted by Genasense. Further
information about these diseases can be found at the website of the Multiple
Myeloma Research Foundation: www.multiplemyeloma.org .
About CLL
Chronic lymphocytic leukemia (CLL) arises in lymphocytes, which are white blood
cells that provide important immune functions and make antibodies. Compared with
normal lymphocytes, CLL cells are unusually long-lived due to high expression of
Bcl-2. Patients with CLL typically have very high numbers of leukemia cells that
circulate in blood and can cause massive enlargement of lymph nodes, spleen, and
liver. Chronic lymphocytic leukemia is the most common form of leukemia in
adults, affecting about 8,000 new patients each year in the U.S.
About Genasense(TM)
Genasense works by inhibiting the production of Bcl-2, a protein made by cancer
cells that is thought to block chemotherapy-induced cell death. By reducing the
amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of
current anticancer treatments. Genasense is currently in multiple, late-stage,
randomized clinical trials in patients with malignant melanoma, multiple
myeloma, chronic lymphocytic leukemia (CLL) and non-small cell lung cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product
portfolio that is focused on anticancer therapy. The Company's research platform
is anchored by oligonucleotide chemistry, particularly applications of
antisense. Genasense(TM), the Company's lead compound, is being developed in
collaboration with Aventis and is currently undergoing late-stage, Phase 3
clinical testing in several clinical indications. Genta's anticancer pipeline
also comprises a portfolio of small molecules, including gallium-containing
compounds, Androgenics compounds for prostate cancer, as well as a series of
DNA-based compounds called "decoy aptamers". For more information about Genta,
please visit our website at: www.genta.com |
