NDA Submission to the FDA Initiated
BERKELEY HEIGHTS and STRASBOURG, FRANCE - September 10,
2003
-Genta Incorporated (Nasdaq: GNTA) and Aventis (NYSE:AVE) today
announced results from their Phase 3 clinical study of GenasenseTM
(oblimersen sodium) plus chemotherapy in patients with malignant
melanoma. In conjunction with these results, the first portion of
the New Drug Application (NDA) has been submitted to the Food and
Drug Administration (FDA) for Genasense in this indication.
Senior executives from Genta and Aventis will discuss results of
the study on a conference call that will be webcast beginning at
8:00 a.m. EST on Wednesday, September 10, 2003.
The Phase 3 trial enrolled patients at 140 sites from 12
different countries. A total of 771 chemotherapy naïve patients
were randomly assigned to receive dacarbazine (a standard
chemotherapy drug) alone or in combination with Genasense. The
primary endpoint of this trial was to compare the
-More-
overall survival between the two treatment arms. Secondary
endpoints included comparative analyses of progression-free
survival and tumor response. The following results were
obtained:
- Analysis of all patients on an intent-to-treat (ITT)
basis showed that the addition of Genasense to dacarbazine
resulted in a median survival of 9.1 months, compared with 7.9
months for patients treated with dacarbazine alone
(P=0.184).
- For patients treated per-protocol who have completed a
minimum follow-up of 12 months (N=480), the addition of Genasense
resulted in a median survival of 10.1 months, compared with 8.1
months for dacarbazine alone (P=0.035).
- For the ITT population (n=771), patients treated with
Genasense plus dacarbazine showed a significant increase in
median progression-free survival to 78 days, compared with 49
days for patients treated with dacarbazine alone (P=0.001).
- For the ITT population (n=771), patients treated with
Genasense plus dacarbazine achieved an antitumor response rate of
11.7% (using RECIST criteria), compared with 6.8% for patients
treated with dacarbazine alone (P=0.019).
- The addition of Genasense to dacarbazine did not appear to be
associated with serious, previously unreported adverse reactions
compared with the use of dacarbazine alone.
"Metastatic melanoma is one of the most devastating
forms of cancer," said Loretta M. Itri, MD Genta's President,
Pharmaceutical Development, and Chief Medical Officer. "These
results have been observed in a disease that is notoriously
unresponsive to standard therapy and for which no approved drug has
shown a survival advantage. We believe the current data support the
NDA submission we have initiated using provisions granted under the
"Fast Track" designation for Genasense."
"One of our primary goals at Aventis is to deliver
innovative products that help patients with cancer live longer with
a better quality of life. Today's promising data may lead to an
important advance in targeted therapies for patients with advanced
malignant melanoma," said Frank Douglas, M.D., Head of Drug
Innovation and Approval, and Member of the Board of Management at
Aventis. "Our collaboration with Genta to develop and co-market
Genasense underscores our commitment to develop breakthrough
late-stage compounds that have significant benefit for patients as
well as commercial potential."
"Genasense may significantly impact the way in
which we treat metastatic melanoma," stated Frank Haluska, MD, PhD,
Director of the Melanoma Program at Massachusetts General Hospital,
and Assistant Professor of Medicine, Harvard Medical School. "The
improvement shown in this very large trial marks a critical step in
using targeted molecular approaches to attack this life-threatening
disease."
The results from this trial will be presented at an
upcoming scientific meeting this Fall.
A live conference call can be accessed as follows:
U.S./Canada: Dial (877) 634-8606, reference code: 2741947.
International: Dial (706) 679-3140, reference code: 2741947.
A replay will be available two hours after the
completion of the conference call and archived through
Friday, October 10, 2003, accessible as follows:
U.S./Canada: Dial (800) 642-1687, enter 2741947 for conference ID.
International: Dial (706) 645-9291, enter 2741947 for conference
ID.
The audio webcast can also be accessed via the web
at Genta's Investor Relations website at:
http://www.genta.com/genta/InvestorRelation/events.html
and will be archived for 30 days.
About Genasense
Genasense is the first oncology drug of its kind to directly target
the biochemical pathway (known as apoptosis) whereby cancer cells
are ultimately killed by chemotherapy. Genasense is believed to
inhibit the production of Bcl-2, a protein that is highly expressed
in malignant melanoma and that is believed to be a fundamental
cause of resistance to anticancer therapy. By inhibiting Bcl-2,
Genasense may greatly improve the activity of anticancer
therapy.
Genasense, which is being developed in
collaboration with Aventis, is currently the subject of 20 clinical
studies, including randomized trials in patients with prostate
cancer, small cell lung cancer, and non-small cell lung cancer.
Additional non-randomized trials are ongoing for patients with
myeloma, non- Hodgkin's lymphoma (NHL), acute myeloid leukemia,
mantle cell lymphoma, and cancers of the breast, lung, colon,
prostate, stomach, pancreas, liver and kidney.
About Melanoma
Malignant melanoma is the most deadly form of skin
cancer. The incidence of this disease is increasing by
approximately 4% annually in the US. In 2002, almost 54,000 cases
of malignant melanoma were diagnosed. Melanoma is the number one
cause of cancer death in women aged 25 to 30. 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 RNA/DNA-based medicines and small molecules. Genasense
TM
(oblimersen sodium), the Company' s lead compound from its RNA/DNA
Medicines program, is being developed with Aventis and is currently
undergoing late-stage, Phase 3 clinical testing. The leading drug
in Genta's small molecule program is Ganite
TM
(gallium nitrate injection), which the Company intends to market
for the treatment of cancer-related hypercalcemia that is resistant
tohydration. For more information about Genta, please visit our
website at:
http://www.genta.com/
.
About Aventis
Aventis is dedicated to treating and preventing disease by
discovering and developing innovative prescription drugs and human
vaccines. In 2002, Aventis generated sales of € 17.6 billion,
invested € 3.1 billion in research and development and employed
approximately 71,000 people in its core business. Aventis corporate
headquarters are in Strasbourg, France. For more information,
please visit:
http://www.aventis.com/
This press release and the associated conference call contain
forward-looking statements with respect to business conducted by
Genta Incorporated and Aventis 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. 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 Companies' Annual
Report/Form 10-K
for 2002.
