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

can 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
'/>"/>

SOURCE Genta Incorporated
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

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:8/26/2014)... ANN ARBOR, Mich. , Aug. 26, 2014 ... pioneering the development of breakthrough oral medicines to ... science of immune modulation, today announced the appointment ... of the company,s scientific advisory board.  Dr. Singh ... and insight to advance Lycera,s multiple ongoing research ...
(Date:8/26/2014)... , Aug. 26, 2014 Trovagene, Inc. ... Generation Dx Summit; Moving Assays to the Clinic ... and Monitoring of Cell Free Tumor DNA in ... component of its Precision Cancer Monitoring (PCM) platform ... sensitivity for the detection of tumor DNA mutations ...
(Date:8/26/2014)... Cary, NC (PRWEB) August 26, 2014 ... built-in GMP processes, implemented a new pricing structure with ... better comply with cGMP and 21 CFR Part 11 ... Good Manufacturing Practices any way we can” said Rick ... the number of available users allowed customers to have ...
(Date:8/26/2014)... Ontario (PRWEB) August 26, 2014 ... Shah as its Director of Business Development. Mr. ... Spartan RX CYP2C19 System in the ... responsible for new business opportunities and strategic initiatives ... Prior to joining Spartan, Mr. Shah was the ...
Breaking Biology Technology:Lycera Appoints Harinder Singh, Ph.D., as Chair of Scientific Advisory Board 2Lycera Appoints Harinder Singh, Ph.D., as Chair of Scientific Advisory Board 3Highly Sensitive and Quantitative Analytical Performance is Translational for Clinical Utility of Cell-Free Tumor DNA Diagnostics 2Highly Sensitive and Quantitative Analytical Performance is Translational for Clinical Utility of Cell-Free Tumor DNA Diagnostics 3Highly Sensitive and Quantitative Analytical Performance is Translational for Clinical Utility of Cell-Free Tumor DNA Diagnostics 4Spartan Bioscience Names Charudutt Shah as Director of Business Development 2
... OmniSonics Medical,Technologies, Inc., a developer of advanced ... disease, announced today that it has enrolled its,first ... I is a prospective,multi-centered U.S. registry study of ... percutaneous mechanical,thrombectomy of acute deep vein thrombosis (DVT). ...
... Signalife, Inc. (Amex:,SGN - News) announced earlier ... financial commitments with respect to acquisitions of the,Company,s ... internationally, including in Japan, other parts of Asia ... the Company,s President and CEO, stated: "I anticipate,closing ...
... ... Surveillance System, EL SEGUNDO, Calif., March 17 ... has been awarded a,task order from the Centers for Disease Control ... System (NEDSS) Base System (NBS). The system helps the CDC,manage and ...
Cached Biology Technology:First Patient Enrolled in SONIC I Registry of OmniSonics Medical Technologies' OmniWave(TM) Endovascular System 2Signalife Sees Accretive Purchase and Financial Commitments 2CSC Continues Support of Centers for Disease Control and Prevention Through New Task Order 2
(Date:8/26/2014)... the University of Liverpool has recommended investing in dog owner ... and problems such as obesity in both people and their ... 1990, the researchers found that access to dog-friendly walking environments ... people to get out and take more exercise with their ... don,t take their dogs for a walk. In the UK, ...
(Date:8/25/2014)... old saying in the biofuels industry: "You can ... a new study may pave the way to ... Department,s National Renewable Energy Laboratory (NREL) demonstrates a ... of lignin into a variety of renewable fuels, ... , " Lignin Valorization Through Integrated Biological Funneling ...
(Date:8/25/2014)... of proteins that promotes virus entry into cells also ... and other viruses, University of Missouri researchers have found. ... insights into our understanding of not only HIV infection, ... Shan-Lu Liu, M.D., Ph.D., associate professor in the MU ... , The study was recently published in the ...
Breaking Biology News(10 mins):Education and dog-friendly neighbourhoods could tackle obesity 2New process helps overcome obstacles to produce renewable fuels and chemicals 2MU researchers discover protein's ability to inhibit HIV release 2MU researchers discover protein's ability to inhibit HIV release 3
... Saskatchewan's Vaccine and Infectious Disease Organization (VIDO) have developed a ... fight against a disease for which no vaccines are yet ... that this vaccination technique may be effective against HCV. The ... , The team, funded by the Canadian Institutes of ...
... and the Department of Horticulture in the College ... have developed a new procedure for the efficient ... of strawberry. The scientists have used Agrobacterium tumefaciens, ... woodland or alpine strawberry Fragaria vesca. , ...
... of molecule which they believe could ultimately lead to ... modified tobacco. Writing in Plant Biotechnology Journal, Dr Patricia ... along with researchers at the University of Warwick say ... far frustrated attempts to turn plants into economically viable ...
Cached Biology News:U of S researchers develop new vaccine candidate against hepatitis C 2Strawberries by design 2Do plants have the potential to vaccinate against HIV? 2
...
Phospho-Btk (Tyr223) Antibody...
...
... to Ki67 - Proliferation Marker, prediluted ... related nuclear protein, expressed by proliferating cells ... cycle (G1, S, G2 and M phase). ... Ki67 antibodies are useful in establishing the ...
Biology Products: