Long-term Followup is Basis of Pending Regulatory Application
In Europe
Paper Accompanied by Editorial Discussing Treatment Results
in Patients with Advanced Disease
BERKELEY HEIGHTS, NJ - September 15, 2006-
Genta Incorporated (NASDAQ: GNTA) today announced that results of
the Company's Phase 3 trial of Genasense® (oblimersen sodium)
Injection in patients with advanced melanoma were published on-line
this week in the Journal of Clinical Oncology, ahead of its print
publication date of October 10, 2006. The paper is accompanied by
an editorial that discusses the trial's results in the context of
current options for melanoma treatment. The extended follow-up data
from this publication form the basis of a Marketing Authorization
Application (MAA) that is currently pending review by the European
Medicines Agency (EMEA).
"In our paper, long-term followup has confirmed the trends that
were observed in the earlier analyses", said Dr. Agop Y. Bedikian,
Professor of Medicine at M.D. Anderson Cancer Center, Houston, TX,
who is the lead author on the paper. "This was the first trial to
achieve such a broad array of positive endpoints. I believe the
aggregate data indicate that Genasense can be a major addition to
chemotherapy for patients with this disease, with a side-effect
profile that is highly manageable." The article can be accessed
on-line at:
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
.
Genasense, Genta's lead anticancer drug, is a novel targeted
therapy that blocks the production of Bcl-2, a protein that appears
to be a fundamental cause of resistance to cancer treatment. By
knocking down Bcl-2 in cancer cells, Genasense may enhance the
effectiveness of chemotherapy in patients with advanced melanoma. A
summary of the data from the final analysis appears below.
Efficacy Data
The report is based on long-term data derived from the largest
randomized controlled trial that has ever been conducted in
patients with advanced melanoma. In this trial, which was conducted
at 139 sites in 9 countries, 771 patients were randomly assigned to
receive chemotherapy with dacarbazine (DTIC) alone or in
combination with Genasense. The paper includes data from a
prospectively defined analysis that evaluated 24-months of minimum
follow-up on all patients. Unless otherwise noted, these results
were based on an intent-to-treat analysis:
|
Endpoint
|
Genasense/DTIC
|
DTIC
|
P
|
| Overall response |
13.5% |
7.5% |
0.007 |
| Complete response |
2.8% |
0.8% |
0.03 |
| Durable response |
7.3% |
3.6% |
0.03 |
| Progression-free survival, median |
2.6 mos. |
1.6 mos. |
0.0007 |
| Overall survival, median |
9.0 mos. |
7.8 mos. |
0.077 |
Prior to randomization, patients were prospectively stratified
according to certain risk factors, including elevated blood levels
of an enzyme known as LDH - a factor that previous clinical
studies have shown is strongly associated with poor outcome. The
final analysis has shown that LDH was the sole stratification
factor significantly associated with a treatment interaction. When
this treatment effect was evaluated, the efficacy of Genasense was
significantly superior for all major efficacy outcomes in patients
who had normal LDH at baseline, a group that comprised
approximately two-thirds of patients in the trial (N=508). In this
group, the following efficacy results were observed:
|
Endpoint
|
Genasense/DTIC
|
DTIC
|
P
|
| Overall response |
17.2% |
9.3% |
0.009 |
| Complete response |
3.4% |
0.8% |
0.04 |
| Durable response |
9.6% |
4.0% |
0.014 |
| Progression-free survival, median |
3.1 mos. |
1.6 mos. |
0.0007 |
| Overall survival, median |
11.4 mos. |
9.7 mos. |
0.018 |
Safety Data
The most frequent serious adverse events that occurred in
>
5% of patients were fever and disease progression (6.2% vs. 2.8%,
and 5.1% vs. 4.7%, respectively, for Genasense/DTIC compared with
DTIC alone). The most frequent Grade 3 or 4 adverse events that
occurred in
>
5% of patients were neutropenia (21.3% vs. 12.5%), thrombocytopenia
(15.9% vs. 6.4%), leukopenia (7.5% vs. 3.9%), anemia (7.3% vs.
4.7%), and nausea (6.7% vs. 2.5%). Although there was an increase
in discontinuations due to adverse events in the Genasense arm (19%
vs. 11%), there was no difference in the number of fatal,
treatment-emergent adverse events (i.e., events that lead to a
death on study or within 30 days from last study treatment).
About Melanoma
Melanoma is the most deadly form of skin cancer. Melanoma is
responsible for more than 90% of all skin cancer deaths. The
European Network of Cancer Registries estimates that more than
60,000 cases of melanoma are diagnosed each year. The incidence of
this disease is increasing by approximately 4 percent annually in
the U.S., where it is the number one cause of cancer deaths for
women aged 25 to 29. For more information on melanoma, please
visit.
http://www.nci.nih.gov/cancer_information/cancer_type/melanoma
About Genta
Genta Incorporated is a biopharmaceutical company with a
diversified product portfolio that is focused on delivering
innovative products for the treatment of patients with cancer. The
Company's research platform is anchored by two major programs that
center on oligonucleotides (RNA- and DNA-based medicines) and small
molecules. Genasense® (oblimersen sodium) Injection is the
Company's lead compound from its oligonucleotide program. The
Company has submitted a New Drug Application (NDA) to the Food and
Drug Administration for the use of Genasense plus fludarabine and
cyclophosphamide for treatment of patients with relapsed or
refractory chronic lymphocytic leukemia (CLL). Genta has also
completed a Marketing Authorization Application to the European
Medicines Agency (EMEA) for use of Genasense plus dacarbazine for
treatment of patients with advanced melanoma. The leading drug in
Genta's small molecule program is Ganite® (gallium nitrate
injection), which the Company is exclusively marketing in the U.S.
for treatment of symptomatic patients with cancer related
hypercalcemia that is resistant to hydration. For more information
about Genta, please visit our website at:
http://www.genta.com//
.
SAFE HARBOR
This press release contains forward-looking statements with
respect to business conducted by Genta Incorporated. By their
nature, forward-looking statements and forecasts involve risks
and uncertainties because they relate to events and depend on
circumstances that will occur in the future. Forward-looking
statements include, without limitation, statements about:
-
the Company's ability to obtain necessary regulatory
approval for Genasense® from the U.S. Food and Drug
Administration ("FDA") or European Medicines Agency
("EMEA");
-
the safety and efficacy of the Company's products or
product candidates;
-
the commencement and completion of clinical trials;
-
the Company's ability to develop, manufacture, license and
sell its products or product candidates;
-
the Company's ability to enter into and successfully
execute license and collaborative agreements, if any;
-
the adequacy of the Company's capital resources and cash
flow projections, and the Company's ability to obtain
sufficient financing to maintain the Company's planned
operations;
-
the adequacy of the Company's patents and proprietary
rights;
-
the impact of litigation that has been brought against the
Company and its officers and directors; and
-
the other risks described under Certain Risks and
Uncertainties Related to the Company's Business, as contained
in the Company's Annual Report on Form 10-K and Quarterly
Report on Form 10-Q.
The Company does not undertake to update any forward-looking
statements. There are a number of factors that could cause actual
results and developments to differ materially. For a discussion of
those risks and uncertainties, please see the Company's Annual
Report on Form 10-K for 2005 and its most recent quarterly report
on Form 10-Q.
SOURCE: Genta Incorporated
CONTACTS:
Investor Relations
Tara Spiess/Andrea Romstad
TS Communications Group, LLC
info@genta.com
(908) 286-3980
Media Relations
Greg Tiberend
Richard Lewis Communications
(212) 827-0020