Trial designs, target populations, and endpoints seen
as critical determinants
BERKELEY HEIGHTS, NJ - November 06, 2006-
Genta Incorporated (NASDAQ: GNTA) announced today that the
Company's Chief Executive Officer, Dr. Raymond P. Warrell, Jr., a
prominent leukemia specialist, delivered a plenary session lecture
at the 11th International Conference on Differentiation Therapy in
Versailles, France. The lecture entitled "Modulation of Bcl-2 as a
Strategy for Enhancing Apoptosis" was presented in the scientific
session "New Frontiers in the Control of Apoptosis" on Sunday,
November 5, 2006. Dr. Warrell reviewed general strategies for
controlling apoptosis, including the underlying science, trial
designs, endpoints, and results using Genasense® (oblimersen
sodium) Injection, Genta's lead anticancer drug, as a prototype for
apoptosis-promoting therapy in patients with chronic lymphocytic
leukemia (CLL).
"To date, no randomized trial - at any stage of CLL - has ever
demonstrated a survival advantage; as such, evidence-based medicine
for assessing therapeutic efficacy requires shorter-term endpoints
that have been validated in prior studies," noted Dr. Warrell. "In
all forms of leukemia, tremendous progress has been made by a
relentless focus on complete remission as a primary goal of
treatment. Until recently, this outcome was uncommon in multiply
relapsed CLL patients, especially those with bulky disease. The
Genasense trial is the only randomized study ever conducted in
relapsed patients. Thus, it provides the first prospectively
collected dataset that link clinical benefit with specific outcome
endpoints."
In all forms of leukemia, achievement of a durable complete
remission (CR) has been considered an unquestionable "clinical
benefit". Patients who attain a durable CR obtain:
- elimination of all overt evidence of leukemia
- sustained relief of disease symptoms
- decreased risks of infection and bleeding
- sustained benefit after discontinuation of chemotherapy
- prolonged duration of remission
- prolonged survival
By contrast, no study has demonstrated that progression-free
survival (PFS) - absent a major objective response - is associated
with clinical benefit in patients with relapsed CLL. Such patients
typically have:
- substantial residual disease
- minimal or no symptomatic relief
- requirement for continuous chemotherapy or immunotherapy to
maintain the lack of progression
- infection and bleeding risks that are unchanged or
increased
Clinical benefit data were prospectively captured for the first
time in the recent Genasense Phase 3 trial. Correlations of these
data with clinical outcome endpoints will be presented at the
upcoming annual meeting of the American Society of Hematology in
December 2006.
In concluding remarks, Dr. Warrell noted that three randomized
controlled trials with Genasense have identified patients who
derive the greatest potential benefit from antiapoptosis
strategies. These results suggest that populations with a high
incidence target expression who have not received extensive prior
therapy may maximally benefit.
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer
cells that is thought to block chemotherapy-induced apoptosis
(programmed cell death). By reducing the amount of Bcl-2 in cancer
cells, Genasense may enhance the effectiveness of current
anticancer treatment. Genta is pursuing a broad clinical
development program with Genasense evaluating its potential to
treat various forms of cancer.
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 Company's assessment of its clinical trials;
-
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;
-
the Company's ability to regain compliance with the
NASDAQ's listing qualifications; 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
