Genasense(TM) Plus Taxotere(R) Reported Active in Patients with Hormone-Refractory Prostate Cancer at ASCO Meeting New Randomized Trial Will Formally Assess Activity of the Combination
CHICAGO, Jun 3, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated
(Nasdaq: GNTA) and Aventis today announced the presentation of clinical data
from a Phase 2 clinical trial of Genasense(TM) (oblimersen sodium), Genta's lead
anticancer drug, in combination with Taxotere(R) (docetaxel) Injection
Concentrate for patients with advanced, hormone-refractory prostate cancer
(HRPC). The results of this trial, which was jointly conducted by Dr. Anthony
Tolcher from the Cancer Treatment and Research Center, San Antonio TX, and Dr.
Kim Chi, from the British Columbia Cancer Center in Vancouver, were presented at
the Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago.
The companies also announced that the European Organization for the Research and
Treatment of Cancer (EORTC) will initiate a new, randomized, multi-center trial
of the Genasense/Taxotere combination in patients with prostate cancer.
Genasense inhibits production of Bcl-2, a protein that is highly expressed in
HRPC and is believed to be a fundamental cause of resistance to anticancer
therapy. Preclinical data from Dr. Tolcher's laboratory -- some of which was
published as part of the annual meeting of the American Association for Cancer
Research -- had established that Genasense amplified the activity of Taxotere in
prostate cancer, and that this synergy was maximized when Genasense was
administered in advance of the chemotherapy, which was the schedule employed in
this clinical trial.
Dr. Chi presented a comprehensive summary of clinical, pharmacokinetic, and
safety data from a trial using the Genasense/Taxotere combination in 29
evaluable patients with HRPC who had received extensive prior treatment. All
patients were refractory to standard hormonal therapy; 6 had failed prior
chemotherapy, and 25 had been previously treated with radiation therapy. A total
of 164 cycles of combined Genasense/Taxotere therapy was administered. Overall,
14 of 29 patients (48%) achieved greater than 50% reduction in blood levels of
PSA (prostate specific antigen), a standard surrogate marker that measures the
extent of prostate cancer. Of the group of patients who had measurable disease
on physical examination or by X-ray, 4 of 13 (31%) showed an objective partial
response.
The new EORTC trial will randomly assign men with HRPC who have not previously
received chemotherapy to either Taxotere alone or Taxotere plus Genasense. The
objectives of the study are to assess activity and safety of the combination.
The study will be chaired by Dr. Cora Sternberg, Chief of the Department of
Medical Oncology at the San Camillo and Forlanini Hospitals in Rome, and will be
conducted at leading cancer centers throughout the European Community.
"Despite the older age of this patient population and their extensive prior
treatment, we are encouraged by the results of the current trial," noted Dr.
Chi. "This combined treatment regimen was generally well tolerated, and the
side-effect profile appears to be similar to reactions that would be encountered
with the use of chemotherapy alone. A randomized comparison of Taxotere with
Genasense or Taxotere alone is the next step in the evaluation of this
innovative combination."
About the EORTC
As the leading cancer cooperative group in Europe, the aims of the European
Organization for Research and Treatment of Cancer (EORTC) are to conduct,
develop, coordinate, and stimulate laboratory and clinical research in Europe to
improve the management of cancer and related problems by increasing patient
survival and quality of life. The EORTC seeks to facilitate the passage of
experimental discoveries into state-of-the-art treatment, and to minimize the
delay between the discovery of new anti-cancer drugs and their therapeutic
benefit for patients with cancer. More information about the EORTC can be
obtained at the organization's website: eortc.be.
About Prostate Cancer
Prostate cancer is the second most common cause of cancer deaths among men in
the U.S. Approximately 180,000 new cases of prostate cancer are diagnosed in the
U.S. each year, and an estimated 31,900 deaths were reported in 2000. Initial
therapy for localized prostate cancer includes either surgical removal or
localized intense radiation therapy. Patients who have extensive disease at the
time of diagnosis, or who relapse from local therapy, are then commonly treated
with drugs that block production of androgen hormones (like testosterone), which
otherwise would stimulate the growth of prostate cancer cells. After treatment
for a median time of 18 months, men usually become refractory to such
anti-androgen therapy, and they are then candidates for chemotherapy, such as
Taxotere. This progression of prostate cancer -- from localized disease, to
metastatic but still hormone sensitive disease, and finally to
hormone-refractory disease -- has been shown to be accompanied by a progressive
increase in Bcl-2 content of prostate cancer cells, which may in part account
for the general resistance of this disease to standard chemotherapy. |
