Genta`s Tesetaxel Granted Fast Track Designation by FDA for Advanced Gastric Cancer

BERKELEY HEIGHTS, N.J.--(Business Wire)--
Genta Incorporated (OTCBB: GETA.OB) today announced that the U.S. Food and Drug
Administration (FDA) has granted the Company`s request for "Fast Track"
designation of tesetaxel for treatment of patients with advanced gastric cancer.
Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane
currently in clinical development.

Fast Track designation is designed to facilitate the development and expedite
the review of new drugs that are intended to treat serious or life-threatening
conditions and that demonstrate the potential to address unmet medical needs.
The designation typically enables a Company to submit a New Drug Application
(NDA) on a "rolling" basis with ongoing FDA review during the submission
process. NDAs with Fast Track designation are also usually granted priority
review by FDA at the time of submission.

Based on promising results in a Phase 2a trial, Genta is conducting a
confirmatory Phase 2b trial of tesetaxel as 2nd-line treatment in patients with
advanced gastric cancer who have failed a single 1st-line regimen. As defined,
the 1st-line regimen must comprise a platinum-containing compound (cisplatin,
carboplatin, or oxaliplatin) and a fluoropyrimidine (5-fluorouracil,
capecitabine, or S-1). The Fast Track designation targets the patient population
that is enrolling in the Phase 2b trial.

Genta has formulated a trial design and clinical protocol for a randomized,
double-blind, placebo-controlled Phase 3 trial of tesetaxel in this patient
population. In developing the trial, the Company completed a dose-ranging and
pharmacokinetic study of tesetaxel plus capecitabine (Xeloda®; Hoffmann LaRoche,
Inc.). Results from that study showed that full doses of each of these orally
administered drugs could be administered together without causing overlapping
side-effects.

Genta plans to submit its proposed Phase 3 trial to FDA in the 2nd-quarter in
order to secure a Special Protocol Assessment (SPA). The Company looks forward
to meeting with the FDA to discuss the trial design.

About Tesetaxel

Taxanes (including paclitaxel and docetaxel) are the most widely used
chemotherapy drug class in cancer medicine. However, these agents are associated
with 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).

Tesetaxel is a novel taxane that is administered by mouth as a capsule. The drug
was developed with a goal of maintaining the high antitumor activity while
eliminating infusion reactions, reducing neuropathy, and increasing patient
convenience. The oral route also enables the development of novel schedules that
may expand dosing options when tesetaxel is combined with other anticancer drugs
(such as "all oral" chemotherapy programs). Tesetaxel has demonstrated high
activity against cell lines that are resistant to paclitaxel and docetaxel.

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 conventional taxanes.
Moreover, unlike other oral taxanes that have been developed, 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.

Tesetaxel in Advanced Gastric Cancer

In the completed Phase 2a 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 capecitabine.
All but 2 of these patients had also received a third chemotherapy drug along
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.

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.
Genasense is being developed as an agent that may enhance the effectiveness of
anticancer therapy. The Company is currently collecting long-term followup data
on durable response and overall survival from the recently completed randomized
Phase 3 study of Genasense in patients with advanced melanoma (the AGENDA
trial). 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. Genta has initiated a broad clinical program to evaluate the safety
and efficacy of tesetaxel in patients with solid tumors. In the U.S., Genta is
exclusively marketing Ganite (gallium nitrate injection), which is indicated for
treatment of symptomatic patients with cancer-related hypercalcemia that is
resistant to hydration. The Company has developed proprietary oral formulations
of the active ingredient in Ganite that are being evaluated as potential
treatments for diseases associated with accelerated bone loss. 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 its product
candidates from regulatory agencies, such as the U.S. Food and Drug
Administration and the European Medicines Agency;
* the safety and efficacy of the Company`s products or product candidates;
* the commencement and completion of any clinical trials;
* the Company`s assessment of its clinical trials;
* the Company`s ability to develop, manufacture, license, or sell its products
or product candidates;
* the Company`s ability to enter into and successfully execute any license and
collaborative agreements;
* the adequacy of the Company`s capital resources and cash flow projections, or
the Company`s ability to obtain sufficient financing to maintain the Company`s
planned operations;
* 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 2009 and its most recent
quarterly report on Form 10-Q.

Genta Investor Relations
908-286-3980
info@genta.com

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