Navigation Links
Positive SPA Reply From the FDA for TopoTarget's Pivotal Trial With Belinostat in PTCL
Date:9/5/2008

Update on the Regulatory Strategy for Belinostat in PTCL

COPENHAGEN, Denmark, September 5 /PRNewswire-FirstCall/ -- TopoTarget A/S (OMX: TOPO) announced that a positive reply from the FDA was received on a Special Protocol Assessment (SPA) for a phase III trial for belinostat in PTCL (Peripheral T-Celle Lymphoma). This pivotal trial is to enrol approximately 120 patients and is to begin in Q4 2008. In June Fast Track designation was granted for the development of belinostat in this indication which supports TopoTarget's rapid market entry strategy. There is currently no standard therapy approved for PTCL.

"This is very good news. We can now move belinostat into a pivotal phase III. With the SPA in place we have agreed on a design for our pivotal phase III trial with the FDA which will begin in Q4 of this year. In addition with the FDA's Fast Track designation received in June for the PTCL indication we can continue with our strategy of rapid market entry for belinostat in an area with a high unmet medical need." Said Professor, Peter Buhl Jensen, MD, CEO of TopoTarget.

Design

The phase III trial is an open-label, multicenter, single arm efficacy and safety trial in patients with relapsed or refractory peripheral T-cell lymphoma who have failed at least one prior systemic therapy. Approximately 120 patients (100 evaluable patients) will be enrolled. Patients will be treated with 1000 mg/m2 belinostat administered as a 30 minute IV infusion on days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

Rational

Belinostat is a small molecule class I and II histone deacetylase inhibitor (HDACi). HDACi's modulate gene expression within tumor cells, including tumor suppressor genes, leading to G1 and G2/M cell cycle arrest, induction of apoptosis (programmed cell death), inhibition of angiogenesis, immune modulation, and promotion of cellular differentiation. Clinic
'/>"/>

SOURCE TopoTarget
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Ondine Announces Presentation of Positive Clinical Trial Results at the American Academy of Periodontologys 94th Annual Meeting
2. Palatin Technologies, Inc. Reports Positive Results of Phase 2a Clinical Study with PL-3994 for the Treatment of Heart Failure
3. SGX - Lilly Merger Offer Receives Positive Opinions From Proxy Advisory Firms
4. BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis
5. Ondine Announces Publication of Positive Results from Pseudomonas aeruginosa Eradication Study
6. BioMS Medicals relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board
7. Thought Leaders Discuss Positive Outlook for Bapineuzumab in Alzheimers Disease in MedPredict Report
8. Positive clinical data for PBI-1402 presented at the Annual Congress of the European Hematology Association
9. Angiotechs corporate partner, Cook Medical, announces positive interim results for its Zilver(R) PTX(TM) clinical study
10. QLT announces positive Health Canada decision on Aczone(R)
11. Quest PharmaTech Announces Positive Results from Phase I Clinical Trial of its Photodynamic Therapy for Actinic Keratosis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/26/2015)... Calif. , Feb. 26, 2015  23andMe, the ... Kate Black as Privacy Officer and Corporate ... and state privacy laws as well as health care ... team, she will be responsible for reviewing, updating and ... in the U.S. and abroad. She joined the company ...
(Date:2/26/2015)... Calif. , Feb. 26, 2015 Protiviti ... the latest version of the Governance Portal , ... governance, risk and compliance (GRC) tasks across multiple business ... been updated to help customers better align their controls ... the Treadway Commission ) requirements. In response to client ...
(Date:2/26/2015)... Feb. 26, 2015  NuGene International, Inc. ("NuGene") ... for skin and hair rejuvenation, has announced that ... of record for investor relations and strategic communications. ... distribution, sales and diversification strategies – and we ... prospective shareholders," stated Ali Kharazmi CEO of NuGene ...
(Date:2/26/2015)... Schaumburg, IL (PRWEB) February 26, 2015 ... to its gauging line by expanding its Length Gauge ... and ACANTO gauges. , Specifically, HEIDENHAIN’s pencil ... an improved force specification. Two new 1Vpp, 12mm ... for lower force applications. One is a variant with ...
Breaking Biology Technology:23andMe Appoints Kate Black as Privacy Officer and Corporate Counsel 2Protiviti Governance Portal Helps Companies Drive Governance, Risk and Compliance Productivity Across Multiple Business Units 2Protiviti Governance Portal Helps Companies Drive Governance, Risk and Compliance Productivity Across Multiple Business Units 3NuGene International, Inc. Selects Capital Market Relations for Strategic Investor Relations 2NuGene International, Inc. Selects Capital Market Relations for Strategic Investor Relations 3Accuracy and Versatile Gauging Go Hand in Hand at HEIDENHAIN 2
... NEW YORK , Aug. 2 Reportlinker.com announces that a new ... , , ... , , ... , , ...
... nanomaterial originally developed to fight toxic waste is ... corrosive drywall. Developed by Kenneth Klabunde of Kansas ... support from the National Science Foundation, the FAST-ACT ... since 2003. Now, NanoScale Corporation of Manhattan, Kansas--the ...
... researchers grow nanowires made of semiconductorsgallium nitride alloysby ... high vacuum. NIST has the unusual capability to ... enhancing luminescence and reducing defects. NIST nanowires also ... experiments, described in Advanced Functional Materials ,* ...
Cached Biology Technology:Asia Pacific Flexible Alternating Current Transmission Equipment Markets 2Asia Pacific Flexible Alternating Current Transmission Equipment Markets 3Asia Pacific Flexible Alternating Current Transmission Equipment Markets 4Asia Pacific Flexible Alternating Current Transmission Equipment Markets 5Asia Pacific Flexible Alternating Current Transmission Equipment Markets 6Asia Pacific Flexible Alternating Current Transmission Equipment Markets 7Decontaminating dangerous drywall 2Nano 'pin art': NIST arrays are step toward mass production of nanowires 2
(Date:2/24/2015)... , Feb. 24, 2015 This report analyzes the ... provides separate comprehensive analytics for the US, Canada ... , Asia-Pacific , Middle ... Annual estimates and forecasts are provided for the period 2013 ... these markets. Market data and analytics are derived from primary ...
(Date:2/19/2015)... .19, 2015 Research and Markets ... the "Military Electro-Optical / Infrared Systems Market ... Platform - Forecast to 2020" report to ... systems market is expected to reach $16.35 billion ... This report segments the military electro-optical/infrared ...
(Date:2/12/2015)... OXFORD, Conn. , Feb. 12, 2015 ... ("NXT-ID" or the "Company"), a biometric authentication company focused ... it has filed provisional patent 62/113114 for ... MULTIPLE DEVICES. The patent further establishes NXT-ID,s ... to its intellectual property portfolio the ability for multiple ...
Breaking Biology News(10 mins):World Iris Biometrics Industry 2World Iris Biometrics Industry 3World Iris Biometrics Industry 4World Iris Biometrics Industry 5World Iris Biometrics Industry 6World Iris Biometrics Industry 7World Iris Biometrics Industry 8World Iris Biometrics Industry 9World Iris Biometrics Industry 10World Iris Biometrics Industry 11Military Electro-Optical / Infrared Systems (Image Intensification, Laser, Infrared) Market - Forecast to 2020: Featuring Profiles of the Market Leaders on this $16 Billion market 2Military Electro-Optical / Infrared Systems (Image Intensification, Laser, Infrared) Market - Forecast to 2020: Featuring Profiles of the Market Leaders on this $16 Billion market 3NXT-ID Patents Collaborative Services to Enable the "Internet of Things" 2NXT-ID Patents Collaborative Services to Enable the "Internet of Things" 3
... today, just think back to about 110 million years ago ... the larger animals, a behemoth called Sauroposeidon proteles, weighed close ... led by the University of Florida suggests it may have ... That is a 118-degree Fahrenheit normal temperature, about as hot ...
... third of the world's people are infected with tuberculosis, ... notoriously hard to treat, requiring a course of multiple ... complete the full course of treatment, which leads to ... treatments could be on the way, however, with a ...
... Shirley Tilghman and colleagues (Princeton University) lend new insight ... role for a non-coding RNA transcript in the silencing ... or the differential expression of a gene based upon ... to normal growth and development. Two human disorders, Prader-Willi ...
Cached Biology News:Large dinosaurs were extremely hot in their day, UF study finds 2Large dinosaurs were extremely hot in their day, UF study finds 3Pitt phage hunter takes on tuberculosis 2
Fast, sensitive quantitation of Mouse IgM concentration....
Request Info...
... IgG FITC is used as the ... on tissues or culture cells where ... rabbits. It is highly recommended that ... the primary antibody, be included in ...
1000X solution used for inducing CopyControl™ based vectors to high copy numbers...
Biology Products: