Navigation Links
Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase Iib EMEA provides Guidance on Phase III Design and Approval Requirements
Date:6/2/2008

or 10 μM AP 12009 in recurrent or refractory anaplastic astrocytoma, with up to 42% at 14 months. At the same time, the initial 25%-overall response rate in the control group fell to zero.

An international, randomized, active-controlled, Phase III study to evaluate the efficacy and safety of AP 12009 as monotherapy in adult patients with recurrent or refractory anaplastic astrocytoma will start in Q3 2008. The study drug will be compared to standard chemotherapy with either Temozolomide or BCNU. Antisense Pharma plans to conduct an interim analysis using the progression rate at 14 months as the surrogate endpoint. Positive results will allow submission for conditional approval by the EMEA. The SAWP at the EMEA indicated that, due to the rarity of the disease, the surrogate endpoint would be accepted, provided that the response data are supported by survival data. The fixed timepoint analysis at 24 months will be acceptable as the primary endpoint for full approval. Furthermore, a time-to-event analysis will be performed. "We are very pleased with this explicit statement by the Scientific Advice Working Party to proceed as we have planned. We sincerely hope that this will accelerate access to treatment for patients in need," says Dr. Hubert Heinrichs, Chief Medical Officer of Antisense Pharma. The Phase III study aims to enroll recurrent or refractory anaplastic astrocytoma patients in about 50 centers in 12 countries.

In the international randomized, active-controlled Phase IIb study, reported at ASCO, recurrent or refractory glioblastoma patients also showed long-lasting tumor responses in the AP 12009 groups (2). As of April 2008 the odds ratio for 10 μM AP 12009 versus control is 0.54. The risk to die is thus reduced by approximately 50% for glioblastoma patients receiving the study drug, as compared to patients under standard chemotherapy treatment. "Based on these data, a pivotal clinical trial in glioblastoma patients with good prognosis, for e
'/>"/>

SOURCE Antisense Pharma GmbH
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at the American Society of Clinical Oncology Meeting in Chicago, Illinois
2. Jazz Pharmaceuticals, Inc. Completes Enrollment in First of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
3. New Nexavar Data Presented in Multiple Tumor Types at 44th American Society of Clinical Oncology Annual Meeting
4. Nektar Announces Expanded Phase 2 Clinical Development Plan For NKTR-102 (PEG-irinotecan)
5. Preliminary Data from Ongoing Phase 1 Data of Investigational Anti-PD-1 Antibody Presented at American Society of Clinical Oncology Annual Meeting
6. CuraGen Announces Data From Ongoing Phase I/II Trial Showing Clinical Activity of CR011-vcMMAE in Metastatic Melanoma
7. BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting
8. Multiple Clinical Trials of VELCADE(R) (Bortezomib) for Injection Based Therapies Demonstrate High Complete Remission Rates in Patients with Newly Diagnosed Multiple Myeloma
9. Exelixis Reports Positive Clinical Pharmacodynamics Data for PI3K/mTOR Inhibitor XL765 at ASCO
10. Sunesis Pharmaceuticals Presents Updated Clinical Data From Ongoing Phase 2 Trial of Voreloxin (Formerly SNS-595) in Ovarian Cancer Patients at the 44th ASCO Annual Meeting
11. About 60 Clinical Studies Regarding Schering-Ploughs Oncology Compounds Will be Presented at ASCO
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ) has announced the addition of ... Size, Share, Growth, Trends And Forecast, 2013 - 2018" ... http://photos.prnewswire.com/prnh/20130307/600769 ) Dental consumables ... to treat dental impairments, for tooth restoration and in ...
(Date:1/15/2014)... Foundation today announced it has established a relief fund ... weather that has gripped much of the nation. AARP and ... to support these emergency relief efforts AARP and AARP Foundation ... up to $500,000 in aid. The matching program will be ...
(Date:1/15/2014)... (the "Company") (NASDAQ: CLSN ) today announced ... purchase an aggregate of approximately $15 million of the ... led by a dedicated health care fund. ... investors pursuant to which the Company agreed to sell ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 2AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3
... Laboratories, Inc. (OTCBB: UGNE), a leader in ... therapeutics, today announced the Company,s Vice President of ... presenting at IBC,s 4th Annual AsiaTIDES Oligonucleotide and ... Hotel in Tokyo, Japan. The TIDES ...
... DIEGO, Feb. 27, 2012 Optimer Pharmaceuticals, Inc. (NASDAQ: ... and fiscal year 2011 financial results and provide a ... the NASDAQ Global Market closes on March 7th.  The ... at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). ...
Cached Medicine Technology:Unigene to Present at IBC's 4th Annual AsiaTIDES Oligonucleotide and Peptide® Conference 2Unigene to Present at IBC's 4th Annual AsiaTIDES Oligonucleotide and Peptide® Conference 3Optimer Pharmaceuticals to Host Conference Call and Webcast to Discuss Fourth Quarter and FY 2011 Financial Results 2
(Date:7/10/2014)... (HealthDay News) -- Nature, not nurture, may play the ... a new study finds. "As is the case ... [thinking] abilities in chimpanzees," William Hopkins of the Yerkes ... news release from the journal Current Biology . ... evolution of intelligence in humans, Hopkins, team said. ...
(Date:7/10/2014)... (HealthDay News) -- Teens who are sensitive to light ... develop emotional symptoms such as anxiety and depression, a ... that may exacerbate issues teens experience after concussion may ... making decisions about when to return to play and ... study authors Lisa Koehl and Dong Han, of the ...
(Date:7/10/2014)... By Dennis Thompson ... -- Forget about the Twitter wars that break out regularly ... can be bad for your own relationship, a new study ... friction within a couple, even if the couple is in ... of 581 Twitter users. In turn, that friction can ...
(Date:7/10/2014)... (Boston) Emergency Medical Service (EMS) responders felt better ... receiving focused tactical training according to a new study ... This is the first study to specifically examine the ... scene where a shooter has not yet been neutralized ... , Incidents such as the Columbine High School shooting, ...
(Date:7/10/2014)... Reducing the amount of alcoholic beverages consumed, even ... a reduced risk of coronary heart disease, lower ... to a new multi-center study published in ... School of Medicine at the University of Pennsylvania. ... which suggest that consuming light-to-moderate amounts of alcohol ...
Breaking Medicine News(10 mins):Health News:Like Humans, Chimps' Smarts May Rely on Genes 2Health News:Some Teens May Face Emotional Problems After Concussion 2Health News:Are You Tweeting Your Marriage Away? 2Health News:Are You Tweeting Your Marriage Away? 3Health News:Active shooter training increases comfort level of emergency responders 2Health News:New study shows drinking alcohol provides no heart health benefit 2
... N.C., June 2 Typical ninth graders are worried about fitting ... from middle school, or keeping up with the latest popular trends--they ... next or other mobility issues. But Luis Magana is not a ... Although Magana was diagnosed with brain cancer almost four years ago, ...
... regain lost trust , TUESDAY, June 2 (HealthDay News) -- ... for not informing the public about its inner workings, announced ... how to be more transparent. , "This is an ... FDA and its processes more transparent to the public," FDA ...
... ... and health and wellness spa treatments that complement conventional medicine through a unique weekend series ... ... Resort & Spa has partnered with Mayo Clinic for the first time ...
... Merchants Inc (NMI), a global leader in payment gateway technologies, ... $50,000 to Schaumburg,s Children,s Home & Aid Family Center. , ... in Schaumburg," said NMI,s CEO Jim McKenzie. "Children,s Home & ... deserves a chance can benefit," McKenzie added. , ...
... Pa., June 2 Royal ... today introduced the Trilogy100 portable at-home life-support ... kg) device marks a milestone in home ventilation from ... bi-level positive airway pressure for noninvasive ventilation nearly 20 ...
... may be more effective than gastric bypass, researchers say ... called duodenal switch surgery may be more effective than ... such as high cholesterol, diabetes and high blood pressure, ... patients who were more than 200 pounds heavier than ...
Cached Medicine News:Health News:The SCOOTER Store Donates Scooter to North Carolina Student With Brain Cancer 2Health News:The SCOOTER Store Donates Scooter to North Carolina Student With Brain Cancer 3Health News:FDA to Study Ways to Be More Open With Public 2Health News:FDA to Study Ways to Be More Open With Public 3Health News:The Westin Kierland Resort And Mayo Clinic Present "Well Beyond" Weekend 2Health News:The Westin Kierland Resort And Mayo Clinic Present "Well Beyond" Weekend 3Health News:The Westin Kierland Resort And Mayo Clinic Present "Well Beyond" Weekend 4Health News:Network Merchants, Inc (NMI) Founders Donate $50,000 to Schaumburg's Children's Home & Aid 2Health News:Photos: Philips Expands Home Healthcare Commitment With Portable Life-Support Ventilator; Offers Ease of Use, Portability and Versatility for Patient 2Health News:Photos: Philips Expands Home Healthcare Commitment With Portable Life-Support Ventilator; Offers Ease of Use, Portability and Versatility for Patient 3Health News:Weight-Loss Surgery Options Compared in Super-Obese 2
... The Minimally Invasive Hip Instruments ... THA through a mini-incision using ... set of instruments helps reduce ... invasive THA by optimizing exposure ...
The Endotrac™ System includes an Obturator, Slotted Cannula, Synovial Elevator, Ligament Probe, Ligament Rasp, Blade Handle, two Retractors and sterilizable tray. The Endotrac&trade....
Instrument set for carpal tunnel release....
Standard arthroscopy graspers for small joints. Also available are Mosquito Tip Graspers, 45 degree Forceps, SquareTrimmer Blunt Tip Forceps and SST Scoop Tip Forceps....
Medicine Products: