Navigation Links
Genta Completes Appeal of FDA Decision for Genasense(R) in CLL
Date:10/25/2007

Submission Seeks Approval of Genasense in Relapsed/Refractory Patients

BERKELEY HEIGHTS, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the Company has completed the filing of the Company's formal appeal to Dr. Janet Woodcock, Acting Director of the Center for Drug Evaluation Research (CDER), at the U.S. Food and Drug Administration (FDA). The appeal asks that CDER approve the use of Genasense(R) (oblimersen sodium) Injection plus chemotherapy for patients with relapsed/refractory chronic lymphocytic leukemia (CLL). In December 2006, FDA issued a non-approvable letter for the Company's New Drug Application (NDA) for Genasense in CLL. This appeal has been submitted in accordance with the Formal Dispute Resolution process that exists within CDER. Responses to CDER appeals are typically made within 30 to 60 days.

The appeal reflects several considerations, including but not limited to the following:

- Complete responses -- the primary endpoint of the trial - were more

than doubled in the Genasense group compared with controls who received

chemotherapy alone. The difference was statistically significant.

- Complete response confers clinical benefit in CLL. By definition, a

complete response requires elimination of all evidence of disease,

normalization of blood counts, and resolution of symptoms.

- The median duration of complete response in patients who received

Genasense has exceeded 3 years, at least 50% longer compared with

controls, which is clinically meaningful and statistically significant.

Survival information from this study will be updated at the annual

meeting of the American Society of Hematology (ASH) in December 2007.

- The Genasense study is the only randomized controlled trial ever

conducted in this population.

- The number, type, and severity of adverse reactions encountered with

Genasense were comparable to other leukemia drugs, which are readily

managed by specialists.

Genasense in CLL

In the pivotal Phase 3 trial, patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial - the first randomized study ever conducted in this population - achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR) (17% vs. 7%; P=0.025). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but exceeding 36 months in the Genasense group vs. 22 months for patients treated with chemotherapy alone).

Prior to randomization on this trial, patients were prospectively stratified according to criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Clear trends, evident across all strata, suggested that the best response to Genasense occurred in patients who had received less extensive therapy. In addition to achieving the prospectively defined, intent-to-treat primary endpoint, patients in the Genasense group who were protocol-defined as "non-refractory" to fludarabine (comprising more than 40% of the total population) achieved:

- A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016)

- Increased time-to-progression (median = 12 months. vs. 10 months;

P = N.S.)

- Increased overall survival (median not reached but exceeding 39 months.

vs. 33 months; P = 0.05)

A scientific report of the safety and efficacy findings from this pivotal study was published earlier this year in the Journal of Clinical Oncology (25:1114, 2007).

Safety

Grade 3 or Grade 4 adverse events that occurred during treatment or within 30 days from last treatment in an increased percentage of patients in the Genasense group included, but were not limited to, thrombocytopenia, nausea, and intravenous-catheter complications. Adverse events resulted in discontinuation of therapy in an equal percentage of patients in both groups. Nine patients in the Genasense group and 5 patients in the chemotherapy-alone group had adverse events that resulted in death, including two patients in the Genasense group who died from complications associated with tumor lysis and infusion-related reactions.

About Chronic Lymphocytic Leukemia

CLL is the most common form of leukemia in adults. According to the American Cancer Society, approximately 8,000 patients will be diagnosed this year. More than 60,000 people in the U.S. currently have CLL. The disease arises in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions. Patients with CLL typically develop symptoms that may progress over a period of years, ultimately producing a generalized depression of immunity, marked increases in the size of spleen, liver and lymph nodes, and impaired production of other normal blood cells. Eventually, these problems may cause life-threatening complications, such as overwhelming infections and fatal bleeding. More information about CLL can be accessed at the website for the Lymphoma Research Foundation at: http://www.lymphoma.org.

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

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. The Company's research platform is anchored by two major programs: 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 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 exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed an oral formulation of the active ingredient in Ganite that is currently undergoing initial clinical trials as a potential treatment for diseases associated with accelerated bone loss. Genta is partnered with IDIS (http://www.idispharma.com) on a program whereby both 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; 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:

Brian Korb

The Trout Group

908-286-3980

info@genta.com


'/>"/>
SOURCE Genta Incorporated
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Sonic Foundry completes $11.25M stock offer
2. Orion Energy completes $5M capital round
3. RedPrairie completes MARC acquisition
4. Metavante completes purchase of check processing firm
5. GE completes $1.2 billion acquisition
6. M & Is Metavante completes Brasfield Corp. acquisition
7. Metavante completes GHR Systems acquisition
8. Metavante completes TREEV acquisition
9. Johnson Controls completes sale of French unit
10. OpGen completes $5 million investment round
11. UW Hospital completes deployment of error-reducing technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... PHILADELPHIA , June 27, 2016  Liquid ... today announced the funding of a Sponsored Research ... study circulating tumor cells (CTCs) from cancer patients.  ... changes in CTC levels correlate with clinical outcomes ... therapies. These data will then be employed to ...
(Date:6/24/2016)... TOKYO , June 24, 2016  Regular discussions on ... to take place between the two entities said Poloz. ... in Ottawa , he pointed to the ... and the federal government. ... Poloz said, "Both institutions have common economic goals, why not ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... While the ... such as the Cary 5000 and the 6000i models are higher end machines that ... the height of the spectrophotometer’s light beam from the bottom of the cuvette holder. ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering with experienced ... this eBook by providing practical tips, tools, and strategies for clinical researchers. , ...
Breaking Biology Technology:
(Date:5/12/2016)... May 12, 2016 WearablesResearch.com , a ... the overview results from the Q1 wave of its ... wave was consumers, receptivity to a program where they ... a health insurance company. "We were surprised ... says Michael LaColla , CEO of Troubadour Research, ...
(Date:5/3/2016)... May 3, 2016  Neurotechnology, a provider of ... MegaMatcher Automated Biometric Identification System (ABIS) , a ... projects. MegaMatcher ABIS can process multiple complex biometric ... combination of fingerprint, face or iris biometrics. It ... and MegaMatcher Accelerator , which have ...
(Date:4/28/2016)... First quarter 2016:   , ... the first quarter of 2015 The gross margin was ... 18.8) and the operating margin was 40% (-13) Earnings ... flow from operations was SEK 249.9 M (21.2) , ... SEK 7,000-8,500 M. The operating margin for 2016 is ...
Breaking Biology News(10 mins):