Genta Incorporated (OTCBB: GNTA) announced today that the Company has
received notice from the U.S. Food and Drug Administration (FDA) that
tesetaxel, the latest addition to Genta’s oncology product portfolio,
has been granted designation as an "Orphan Drug” for treatment of
patients with advanced gastric cancer. Orphan drug status provides for a
period of marketing exclusivity, certain tax benefits, and an exemption
from certain fees upon submission of a New Drug Application. As a late
Phase 2 agent, the Company believes tesetaxel is the leading oral taxane
currently in clinical development.
In the completed Phase 2 study, 35 patients with advanced gastric cancer
were treated with tesetaxel at doses ranging from 27 to 35 mg/m2
once every three weeks. All patients had received extensive prior
treatment, having failed a combination regimen that included cisplatin
plus 5-fluorouracil or Xeloda®, and all but 2 patients had
received a third chemotherapy drug with this regimen. Final
intent-to-treat analysis, including all patients enrolled in the study,
showed that 5 patients achieved a partial response, 2 patients achieved
a partial response unconfirmed by CT scan, and 14 patients achieved
stable disease, for an overall major response rate of 20% and a
disease-control rate of 60%. The most serious adverse reaction was Grade
3-4 neutropenia, which occurred in 57% of patients. Six patients failed
to complete the first course of treatment. Five patients died on study
from differing causes that included intestinal perforation, pneumonia,
hepatic failure, hemorrhagic shock, and rapid disease progression. One
patient withdrew before receiving the first treatment dose.
"These response data for tesetaxel in a critically ill patient
population show clinical activity at levels that are at least comparable
to studies with other taxanes,” said Dr. Raymond P. Warrell, Jr.,
Genta’s Chief Executive Officer. "Based on these data, we have consulted
extensively with international experts and will be defining a global
registration path for tesetaxel as a 2nd-line treatment for
patients with advanced gastric cancer. FDA designation as an Orphan Drug
provides important assistance in the clinical development process.”
About Tesetaxel
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in
the same class of drugs as paclitaxel and docetaxel. However, both
prototype agents suffer from serious safety issues, particularly
hypersensitivity reactions related to intravenous infusions that are
occasionally fatal and that require careful premedication and
observation. Other prominent side-effects of this drug class include
myelosuppression (low blood counts) and peripheral neuropathy (disabling
nerve damage).
With administration as an oral capsule, tesetaxel was developed to
maintain the high antitumor activity of the taxane drug class while
eliminating infusion reactions, reducing neuropathy, and increasing
patient convenience. The oral route also enables development of novel
schedules that may expand dosing options when tesetaxel is used alone or
in combination with other anticancer drugs. Preclinically, tesetaxel has
demonstrated substantially higher activity against cell lines that were
resistant to paclitaxel and docetaxel, since acquired resistance is not
mediated by the multidrug-resistant p-glycoprotein.
As a late Phase 2 oncology product, tesetaxel has demonstrated
anticancer activity in its initial clinical trials, and the drug has not
been associated with the severe infusion reactions that are linked with
other taxanes. Moreover, unlike other oral taxanes, nerve damage has not
been a prominent side effect of tesetaxel. Thus, the drug offers
substantial opportunities to improve patient convenience, safety, and
anticancer activity. More than 250 patients worldwide have been treated
with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
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. The Company is also developing tesetaxel,
a novel, orally absorbed, semi-synthetic taxane that is in the same
class of drugs as paclitaxel and docetaxel. 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.
Such forward-looking statements include
those that express plan, anticipation, intent, contingency, goals,
targets, or future developments and/or otherwise are not statements of
historical fact.
The words "potentially”, "anticipate”, "could”,
"calls for”, and similar expressions also identify forward-looking
statements.
The Company does not undertake to update any
forward-looking statements.
Factors that could affect actual
results include, without limitation, risks associated with:
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the Company’s ability to obtain necessary regulatory approval for
Genasense® from the U.S. Food and Drug
Administration ("FDA”);
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the safety and efficacy of the Company’s products or product
candidates;
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the Company’s assessment of its clinical trials;
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the commencement and completion of clinical trials;
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the Company’s ability to develop, manufacture, license and sell its
products or product candidates;
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the Company’s ability to enter into and successfully execute
license and collaborative agreements, if any;
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the adequacy of the Company’s capital resources and cash flow
projections, the Company’s ability to obtain sufficient financing to
maintain the Company’s planned operations, or the Company’s risk of
bankruptcy;
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the adequacy of the Company’s patents and proprietary rights;
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the impact of litigation that has been brought against the Company;
and
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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.
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 2007 and its most recent quarterly report on Form 10-Q.