Genta Summarizes Phase 2 Activity & Receives Orphan Drug Designation in Gastric Cancer for Tesetaxel, a Leading Oral Taxane i...
January 05 2009 - 8:21AM
Business Wire
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: the
Company�s ability to obtain necessary regulatory approval for
Genasense� from the U.S. Food and Drug Administration (�FDA�); 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, the Company�s ability to obtain sufficient financing
to maintain the Company�s planned operations, or the Company�s risk
of bankruptcy; the adequacy of the Company�s patents and
proprietary rights; the impact of litigation that has been brought
against the Company; 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. 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.