Updated Phase 3 Results Released at American Society of
Hematology Meeting
BERKELEY HEIGHTS, NJ - December 10, 2007
- Genta Incorporated (NASDAQ: GNTA) announced the release of new
survival analyses based upon extended follow-up of patients in the
Company's randomized Phase 3 trial of Genasense® (oblimersen
sodium) Injection for relapsed or refractory chronic lymphocytic
leukemia (CLL). The new data show that patients who achieved
complete remission (the primary endpoint of the trial) with
Genasense plus chemotherapy have shown extended survival compared
with patients whose complete remission was induced with
chemotherapy alone. The data were released this weekend at a
press briefing sponsored by the American Society of Hematology
(ASH) and will be presented in a scientific session on Tuesday
December 11, 2007 at the ASH annual meeting in Atlanta, GA by Dr.
Susan O'Brien, Professor of Medicine, M.D. Anderson Cancer Center,
Houston, TX.
The new data show that the median survival of patients treated with
Genasense plus chemotherapy who achieved complete remission (CR,
defined as complete plus nodular partial response) has still not
been reached but currently exceeds 55+ months, compared to a median
of 45 months in the chemotherapy-alone group. Of 20
patients in the Genasense group who achieved CR, 12 (60%) remain
alive compared with 3 of the 8 patients who achieved CR with
chemotherapy alone (38%). With a minimum follow-up of 54
months, 9 of the 12 CR patients in the Genasense group have not
required additional therapy, and 5 (25%) remain in continuous
CR. In the chemotherapy-alone group, all 3 survivors who
previously achieved CR have relapsed, and all have required
additional anti-leukemic therapy.
Genta has filed a currently pending appeal to the Food and Drug
Administration (FDA) Center for Drug Evaluation and Research
(CDER), which seeks reconsideration of FDA's decision in December
2006 not to approve the use of Genasense in patients with
relapsed/refractory CLL.
"The addition of Genasense to chemotherapy has resulted in a
clinically meaningful survival benefit for patients who achieved
CR," commented Dr. O'Brien. "These data strongly confirm the
high degree of clinical benefit that accrues to patients who
achieve CR. Achievement of CR remains an essential goal of
CLL treatment."
"As one of the patients who remains in CR more than 4 years after
receiving Genasense on this study, I strongly support the pending
appeal of FDA's decision that declined to make this drug available
to other patients who suffer from CLL," commented Thomas F.
Mahoney, who entered the Phase 3 Genasense trial in 2002.
Genasense in CLL
In the Phase 3 trial, patients with relapsed or refractory CLL were
randomly assigned to receive chemotherapy with fludarabine plus
cyclophosphamide (Flu/Cy) with or without Genasense. This
study - the only randomized controlled trial ever conducted in this
population - achieved its intent-to-treat primary endpoint, which
was a statistically significant increase in the proportion of
patients who achieved a complete or nodular partial response (CR)
(17% vs. 7%; P=0.025). By definition, CR represents the
complete elimination of all clinical signs of leukemia, combined
with the elimination of leukemia-related symptoms. In
addition, the duration of CR - a prospectively specified and
independent secondary endpoint -- was also significantly longer for
patients treated with Genasense (median not yet reached but
exceeding 36 months in the Genasense group compared with 22 months
for patients treated with chemotherapy alone).
The data presented today are exploratory analyses based on extended
follow-up of all patients who achieved CR in the Phase 3
trial. Previously, a survival benefit had been demonstrated
only in CR patients who were prospectively stratified prior to
randomization as being "non-refractory" to chemotherapy using a
standard definition. (The prior data can be accessed at:
http://www.genta.com/index.php?option=com_content&task=view&id=60&Itemid=&CID=44&SHID=&COID=
). The new data show that this superior survival benefit for
Genasense-treated patients extends to all patients who achieved
CR/nPR. These data are presented in the table below.
|
Survival
|
Genasense/Flu/Cy
|
Flu/Cy
|
p-value
|
|
1 year
|
20
|
8
|
0.016
|
|
2 years
|
17
|
8
|
0.06
|
|
3 years
|
16
|
4
|
0.005
|
|
4 years
|
12
|
2
|
0.006
|
Safety
Grade 3 or Grade 4 adverse events that occurred during treatment or
within 30 days from last treatment in an increased percentage of
patients in the Genasense group included, but were not limited to,
thrombocytopenia, nausea, and intravenous-catheter complications.
Adverse events resulted in discontinuation of therapy in an equal
percentage of patients in both groups. Nine patients in the
Genasense group and 5 patients in the chemotherapy-alone group had
adverse events that resulted in death, including two patients in
the Genasense group who died from complications associated with
tumor lysis and infusion-related reactions.
A scientific report of the safety and efficacy findings from this
study was published earlier this year in the Journal of Clinical
Oncology (25:1114, 2007).
Regulatory History of Genasense in CLL
Genta filed a New Drug Application (NDA) to FDA for the use of
Genasense plus chemotherapy in patients with relapsed/refractory
CLL in December 2005. In December 2006, FDA issued a
non-approvable decision on this NDA. Genta has appealed this
decision using FDA's established Dispute Resolution Process.
An initial review of this appeal by FDA's Office of New Drugs
declined to overturn the earlier decision. Genta has appealed
the non-approvable decision to CDER, which is currently
pending.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. According to the
American Cancer Society, approximately 8,000 patients will be
diagnosed this year. More than 60,000 people in the U.S.
currently have CLL. The disease arises in lymphocytes, a type
of white blood cell that normally produces antibodies and serves
important immune functions. Patients with CLL typically develop
symptoms that may progress over a period of years, ultimately
producing a generalized depression of immunity, marked increases in
the size of spleen, liver and lymph nodes, and impaired production
of other normal blood cells. Eventually, these problems may cause
life-threatening complications, such as overwhelming infections and
fatal bleeding. More information about CLL can be accessed at
the website for the Lymphoma Research Foundation at:
http://www.lymphoma.org
.
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. Two major programs
anchor the Company's
research platform
: DNA/RNA-based Medicines and Small Molecules.
Genasense® (oblimersen sodium)
Injection is the Company's lead compound from its DNA/RNA Medicines
program. Genta is currently recruiting patients to the
AGENDA Trial
, a global Phase 3 trial of Genasense in 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. The Company has developed
G4544, an oral formulation of the active ingredient in Ganite, that
has recently entered clinical trials as a potential treatment for
diseases associated with accelerated bone loss. Ganite® and
Genasense® are available on a "
named-patient
" basis in countries outside the United States. For more
information about Genta, please visit our website at:
www.genta.com
.
Safe Harbor
This press release may contain 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 and any proposed
settlement of such litigation;
-
the Company's ability to retain 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 2006 and its most recent
quarterly report on Form 10-Q.
CONTACT:
Nichol Harber
Genta Investor Relations
info@genta.com
908-286-3980
