Genta CEO Provides Clinical, Regulatory, and Financial Update at Banc of America Conference
LAS VEGAS, Mar 26, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated
(Nasdaq: GNTA) yesterday presented a corporate update focused on its late stage
programs at the Banc of America 2003 Healthcare Conference in Las Vegas, NV. Dr.
Raymond P. Warrell, Jr., MD, Genta's Chairman and Chief Executive Officer,
provided an overview of the Company's lead anticancer programs, Genasense(TM)
(oblimersen sodium) and Ganite(TM) (gallium nitrate injection), that included
strategic development plans, as well as recent clinical and regulatory
hallmarks. The following topics were addressed:
Genasense(TM)
* Genasense blocks production of a key protein called Bcl-2 -- a factor
that is widely believed to contribute to the inherent resistance of
cancer cells to current anticancer treatment. In all of its programs,
Genasense is being evaluated for its ability to amplify the
effectiveness of current cancer chemotherapy.
* Within the last 3 months, the Company completed target accrual into the
first three randomized Phase 3 trials with Genasense. These trials
include patients with malignant melanoma, multiple myeloma, and chronic
lymphocytic leukemia. Data from at least one of these trials are
expected to be evaluated and announced later this summer enabling a new
drug application (NDA) filing for that indication.
* In collaboration with Aventis, the Company is currently conducting a
fourth randomized clinical trial of Taxotere(R) (docetaxel, Aventis)
with or without Genasense in patients with non small cell lung cancer
who have failed or relapsed from first-line treatment.
* Either alone or in collaboration with the U.S. National Cancer
Institute, the Company is currently conducting 10 additional
non-randomized trials. These studies employ Genasense in combination
with drugs such as Gleevec(R) (iminitab salysilate; Novartis)
Rituxan(R) (rituximab; IDEC/Genentech), Taxotere(R) (docetaxel;
Aventis) Thalomid(TM) (thalidomide, Celgene), 5-FU, carboplatin, and
oxaliplatin (Eloxatin(R); Sanofi-Synthelabo, Inc.). Some of the
diseases currently under study include acute and chronic myeloid
leukemia, non-Hodgkin's lymphoma (NHL), pediatric solid tumors, small
cell lung cancer, colorectal cancer, and prostate cancer. The Company
expects to initiate additional non-randomized trials during 2003.
Ganite(TM)
* By the end of the first-quarter 2003, Genta will have completed the
submission of its supplemental New Drug Application (sNDA) to the Food
and Drug Administration's (FDA) Metabolism and Endocrine Division for
Ganite. The supplements relate to certain changes in manufacturing of
drug substance and drug product.
* Assuming there are no important delays in the review of its
submissions, the Company believes it will be able to initiate marketing
of the drug during the second-half of 2003. Ganite is approved for the
treatment of cancer-related hypercalcemia, a life-threatening elevation
of blood calcium that can occur in up to 20% of cancer patients.
* In addition to building its marketing team, Genta is currently
expanding its oncology-focused field force to effectively manage the
commercial goals and objectives for Ganite. Genta intends to retain
all commercial rights to Ganite and plans to sell the drug exclusively
in the U.S.
* Several Phase 2 clinical trials have shown that Ganite has important
anticancer activity as a single-agent in several diseases, including
NHL and bladder cancer. Following final approval of the sNDA, Genta
intends to confer with the FDA's Oncology Drug Products Division on a
registration strategy for Ganite that will focus on the use of somewhat
higher doses as a treatment for patients with relapsed NHL. Genta has
opened an Investigational New Drug (IND) exemption for this purpose
with the Oncology Division and has initiated its first clinical trial
in NHL under Company sponsorship in the U.S.
* Genta has submitted an application to the FDA for designation of Ganite
as an Orphan Drug for the treatment of patients with non-Hodgkin's
lymphoma (NHL).
Genta's Financial Position
* Genta's financial strength was bolstered earlier this month by the
securing of a line of credit from Aventis. This facility affords an
opportunity to immediately bring forward up to $40 million from the
first milestone payment due the Company under the collaboration
agreement with Aventis at the time of first Genasense approval in the
U.S. Genta has indicated that it intends to draw upon this line of
credit before the end of the 1st-quarter 2003. Funds will be used to
purchase drug for expanded use in clinical trials and to offset
clinical trials costs that are subject to reimbursement by Aventis,
pursuant to collaboration agreements of the two companies.
The Genta corporate presentation can be accessed via the web through Genta's
investor site at: genta.com. A replay will be available
until April 11, 2003.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product
portfolio that is focused on anticancer therapy. The Company's research platform
is anchored by oligonucleotide chemistry, particularly applications of antisense
and decoy aptamer technology. Genasense(TM), the Company's lead compound, is
being developed in collaboration with Aventis and is currently undergoing
late-stage, Phase 3 clinical testing in several clinical indications. Genta's
pipeline also comprises a portfolio of small molecules, including
gallium-containing compounds and Androgenics compounds for prostate cancer. For
more information about Genta, please visit our website at: www.genta.com |
