Responses Observed at Lower Doses -- "Flat Dosing"
Feasible
BERKELEY HEIGHTS, NJ - June 1, 2009
- Genta Incorporated (OTCBB: GNTA.OB) announced preliminary
results from its ongoing clinical study of tesetaxel, a leading
oral taxane in the Company's investigational drug portfolio.
The new data show a favorable safety profile with a low incidence
of serious adverse events, along with objective responses that have
been observed at less than the maximally tolerated dose
(MTD). The data are featured in a presentation today at
the annual meeting of the American Society of Clinical Oncology
(ASCO) in Orlando, FL.
The new clinical study has accrued 12 patients at doses ranging
from 18 to 24 mg/m2 administered once every 3 weeks. To date,
only one Grade 4 episode of neutropenia (the dose-limiting reaction
for all taxanes) has been observed. Three objective and
ongoing responses have been observed in the first 9 evaluable
patients who received at least 2 doses, including one patient each
with nasopharyngeal cancer (partial response), gastrointestinal
stromal tumor (GIST) (minor response), and uterine cancer (minor
response). Of note, all responses have occurred in older
subjects (ages 83, 84 and 64, respectively) and at less than the
previously established MTD of 27 mg/m2.
The presentation also examined the feasibility of converting the
common practice of weight-based dosing (as in mg/m2 of body surface
area) to "flat dosing". For oral drugs like tesetaxel, flat
dosing is far more accurate and convenient for patients and
physicians. Pharmacokinetic analysis indicated that a fixed
dose of 50 mg would be suitable for most Western patients.
"Prior Phase 2 studies have documented substantial antitumor
activity in patients with advanced gastric cancer and breast cancer
at the highest dose level of 27 mg/m2," noted Dr. Raymond P.
Warrell, Jr., Genta's Chief Executive Officer. "However, we
were very pleased to observe major responses using lower doses,
especially the response in nasopharyngeal cancer at 21 mg/m2.
Importantly, the incidence of neutropenia has been acceptably low
-- similar to other drugs in this class - and the tolerability in
older subjects has also been impressive. We believe tesetaxel
may offer patients major advantages compared with standard taxanes,
and we look forward to accelerating our development programs with
this new agent."
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.
Tesetaxel has demonstrated anticancer activity in several Phase
2 clinical trials. The drug has not been associated with
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 260 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. 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:
http://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 2008 and its most recent quarterly report
on Form 10-Q.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
info@genta.com
