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Genasense in Medical News

FDA Accepts Genta's NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia

...a "complete response". The NDA proposed the use of genasense plus chemotherapy for patients with relapsed or re...d a complete or partial response when treated with genasense plus chemotherapy compared with patients treated w...appeal of a prior "non-approvable" decision of the genasense NDA in December 2006. That communication described...

Genta Announces Licensing Agreement for Worldwide Development and Commercialization of a Leading Oral Taxane, Tesetaxel

... 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(R) (gallium nitrate injection), which the Company is ...

Genta Announces Resignation of Dr. Betsy McCaughey from Board of Directors

...ium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients for a global Phase 3 trial of genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is ...
Genasense in Medical Technology

Genta Updates Progress of its Phase 3 Trial of Genasense(R) in Patients with Advanced Melanoma

...that is intended to support global registration of genasense for patients with advanced melanoma. The study is ...acy results from Genta's prior randomized trial of genasense combined with dacarbazine (DTIC) in patients ident...acy results from an antecedent randomized trial of genasense combined with dacarbazine (DTIC) in patients who h...

FDA Lifts Clinical Hold on Genta's Tesetaxel, a Leading Oral Taxane

... 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(R) (gallium nitrate injection), which the Company is ...

Genasense(R) Chemotherapy Program Yields High Response Rate in Patients with Stage 4 Melanoma

...or patients with advanced melanoma. In this study, genasense was used to potentially enhance the clinical activ...od marker that was shown to affect the response to genasense plus chemotherapy in a recent randomized trial.) T...CR+PR+SD) of 64%. Laboratory studies showed that genasense did not alter the expected pharmacokinetics of pac...

Long-Term Followup in Phase 3 CLL Trial Shows Genasense(R) is Associated with Significantly Increased Survival in All Responders

...nodular partial response (CR) with the addition of genasense to the Flu/Cy regimen. (17% vs. 7%; P=0.025). In a...lso significantly longer for patients treated with genasense (median not reached but estimated to exceed 36 mon...own that all major responses (CR+PR) achieved with genasense have now been associated with significantly increa...

Genta Clinical Programs Featured in Multiple Abstracts at the Annual Meeting of the American Society of Clinical Oncology

... 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(R) (gallium nitrate injection), which the Company is ...

Genta Receives Key Patent Related to Oral Gallium Compound G4544

... 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(R) (gallium nitrate injection), which the Company is ...

Specialized Genasense(R) Clinical Trials Featured at AACR Meeting

... Quereshi A, et al. Summary: Describes the PK of genasense in patients with impaired kidney function that may...opulation pharmacokinetics (PK) of dacarbazine and genasense in adult patients with advanced melanoma. Authors:...ezai K, et al. Summary: Describes the PK of both genasense and dacarbazine (the chemotherapy drug given to al...

DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma

...toring Board (DSMB) for AGENDA, a Phase 3 trial of genasense (oblimersen sodium) Injection, which is the Compan...that is intended to support global registration of genasense for patients with advanced melanoma. The study is ...acy results from Genta's prior randomized trial of genasense combined with dacarbazine (DTIC) in patients ident...

FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data

...al Officer. "Our approach mirrors our strategy for genasense in melanoma in which a smaller Phase 3 trial, expe...nfirmatory data." Proposed Confirmatory Trial of genasense in CLL The proposed protocol, based on results o...re - and they will be randomly assigned to receive genasense or no additional therapy. The trial will seek to c...

Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate Highlights

... melanoma trial -- Decision on FDA appeal for genasense NDA in CLL expected this quarter "Genta now has ...mpany has an ongoing Phase 1-2 trial that combines genasense with Abraxane(R) (paclitaxel protein-bound particl... appealed a prior "non-approvable" decision on the genasense New Drug Application (NDA) for patients with relap...
Genasense in Biological Technology

Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia

Submission Based on Increased 5-Year Survival Data for Responding Patients BERKELEY HEIGHTS, N.J., June 6 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced that the Company has submitted an amendment to the Food and Drug Administration (FDA) for its New Drug Appl...

Independent Monitoring Board Recommends Completion of Accrual to Genasense(R) Phase 3 AGENDA Trial in Advanced Melanoma

...that is intended to support global registration of genasense for patients with advanced melanoma. The study is ...acy results from Genta's prior randomized trial of genasense combined with dacarbazine (DTIC) in patients ident...eb/announcements/a030-01.asp . About Genasense genasense inhibits production of Bcl-2, a protein made by ca...

Genta Incorporated Announces Second Quarter 2008 Financial Results and Corporate Highlights

... CLL submitted to FDA -- AGENDA Phase 3 trial of genasense in melanoma updated at EADO -- Clinical hold on ...e Leading Antisense Drug in Clinical Development genasense in Melanoma: Genta is currently enrolling patients with advanced melanoma in a Phase 3 trial of genasense plus chemotherapy, known as AGENDA. AGENDA is a ra...

Genta Announces Second Quarter 2008 Financial Results and Conference Call

... 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(R) (gallium nitrate injection), which the Company is ...

Genta Receives Notice of Allowances for European Patents Related to Composition and Processes for Tesetaxel, a Leading Oral Taxane

...nts to the AGENDA Trial, a global Phase 3 trial of genasense in patients with advanced melanoma. The Company ha... Administration requesting approval for the use of genasense plus chemotherapy in patients with relapsed or ref...drug class as paclitaxel and docetaxel. Ganite and genasense are available on a "named-patient" basis in countr...

Genta Secures Up to $40 Million Convertible Financing Facility to Fund Key Programs

...o fully enroll the ongoing Phase 3 AGENDA trial of genasense in melanoma, to pursue regulatory actions related to the use of genasense in chronic lymphocytic leukemia, and to make subst...nts to the AGENDA Trial, a global Phase 3 trial of genasense in patients with advanced melanoma. The leading dr...

Genta Incorporated Announces First Quarter 2008 Financial Results and Corporate Highlights

... product -- FDA provides regulatory guidance for genasense in CLL -- Company restructures to conserve cash ...he Leading Antisense Drug in Clinical Development genasense in Melanoma: Genta is currently enrolling patients...advanced melanoma in a randomized Phase 3 trial of genasense plus chemotherapy, known as AGENDA. The study is d...

Genta Announces Transfer of its Common Stock to the OTC Bulletin Board

... 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(R) (gallium nitrate injection), which the Company is ...

Genta Announces Pending Transfer of its Common Stock to the Over-the-Counter Bulletin Board

... 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(R) (gallium nitrate injection), which the Company is ...

Genta Restructures Operations to Focus on Priority Initiatives

...ER, this decision precludes a commercial launch of genasense during 2008, and accordingly the Company has reduc...ll be maintaining our "named-patient" programs for genasense and Ganite. However, given the delays in commercia..., and we anticipate clinical presentations on both genasense and G4544 -- an oral compound that reduces calcium...
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