Navigation Links
FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia
Date:1/14/2008

BERKELEY HEIGHTS, N.J., Jan. 14 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced today that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasense(R) (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia. The Company had previously provided guidance that a final decision would be available in the fourth quarter of 2007. Genta now envisions receiving this notification later in the current quarter.

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(R) (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(R) (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. Ganite(R) and Genasense(R) 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. Forward- looking statements include, without limitation, statements about:

-- the Company's ability to obtain necessary regulatory approval for

Genasense(R) from the U.S. Food and Drug Administration ("FDA") or

European Medicines Agency ("EMEA");

-- 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, and 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

its officers and directors and any proposed settlement of such

litigation;

-- the Company's ability to regain compliance with the NASDAQ's listing

qualifications; 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.

The Company does not undertake to update any forward-looking statements. 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 2006 and its most recent quarterly report on Form 10-Q.

CONTACT:

Nichol Harber

Genta Investor Relations

908-286-3980

info@genta.com


'/>"/>
SOURCE Genta Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
2. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
3. Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)
4. Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
5. Berkery Noyes Represented The Thomson Corporation in the Sale of CenterWatch and New England Institutional Review Board to Jobson Medical Information
6. FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma
7. Initiation of Coverage Informational Review Issued by Scimitar Equity Research
8. Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
9. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
10. Review of Probiotic Trial Research Finds Only Bifantis(R) Able to Claim Efficacy versus Placebo for IBS Symptoms
11. Risks Associated With Face Transplants May Be Lower Than Previously Thought, ASPS Journal Review Suggests
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... --  Pulmatrix, Inc ., (NASDAQ: PULM ), ... today that it was added to the Russell Microcap ... set of U.S. and global equity indexes on June ... for Pulmatrix," said Chief Executive Officer Robert Clarke ... in developing drugs for crucial unmet medical needs, and ...
(Date:6/23/2016)... June 23, 2016  MedSource announced today that ... e-clinical software solution of choice.  This latest decision ... value to their clients by offering a state-of-the-art ... relationship establishes nowEDC as the EDC platform of ... full-service clients.  "nowEDC has long been a preferred ...
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
Breaking Medicine Technology:
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... ... Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair ... hour by 2020 and then adjusting it yearly to increase at the same rate as ... the wage floor does not erode again, and make future increases more predictable. , The ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... ... Haute Living, is proud to recognize Dr. Barry M. Weintraub as a prominent ... “the most beautiful women in the world, and the most handsome men, look ...
Breaking Medicine News(10 mins):