Navigation Links
TorreyPines Therapeutics Reports Successful End-of-Phase II Meeting With FDA for Tezampanel
Date:10/1/2008

LA JOLLA, Calif., Oct. 1 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that it held a successful End-of-Phase II meeting for tezampanel with the U.S. Food and Drug Administration (FDA) on September 29, 2008. Based on a review of the Phase II data, the FDA agreed that TorreyPines may initiate a Phase III program for tezampanel in acute migraine. The FDA also confirmed that the required thorough QT/QTc study for tezampanel can be conducted in parallel with the first Phase III pivotal trial. The timing for initiation of a Phase III trial is dependent on the company securing a development partner or funding for the program.

The FDA meeting follows the successful completion of a 306-patient, Phase IIb acute migraine trial that demonstrated a single 40 mg dose of tezampanel was safe, well-tolerated and effective in relieving headache pain at two hours post-dose. The Phase III clinical trial design for tezampanel will evaluate the 40 mg dose as well as a lower dose, consistent with the FDA recommendation that the lowest effective dose should be identified in the development of investigational drugs.

"We are pleased with the outcome of our meeting with the FDA and their go-ahead for a Phase III program," said Ev Graham, acting chief executive officer of TorreyPines. "This successful milestone, the first in a series of clinical milestones we expect to meet this year, should significantly help us achieve our strategy of securing a corporate partner or other funding to continue development of tezampanel. We are also on track to report by the end of the year, data from our ongoing Phase I study of NGX426, the oral prodrug of tezampanel, in a capsaicin model of hyperalgesia, as well as a Phase II study of
'/>"/>

SOURCE TorreyPines Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. TorreyPines Therapeutics to Present at the NewsMakers in the Biotech Industry Conference
2. TorreyPines Therapeutics to Present at ThinkEquitys G5 Conference
3. TorreyPines Therapeutics and Eisai Co., Ltd. Extend Genetics Discovery Collaboration for Alzheimers Disease
4. TorreyPines Therapeutics to Present at ThinkEquitys ThinkClinic Conference
5. TorreyPines Therapeutics to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
6. TorreyPines Therapeutics Reports Third Quarter 2007 Results
7. TorreyPines Therapeutics to Present at Susquehanna Financial Groups Second Annual SIGnificant Options in Healthcare Conference
8. TorreyPines Therapeutics Initiates Phase II Study of Muscarinic Agonist NGX267 for Treatment of Xerostomia
9. TorreyPines Therapeutics Reports Fourth Quarter and Full Year 2007 Financial Results and Highlights
10. TorreyPines Therapeutics to Host First Quarter 2008 Results Conference Call and Webcast
11. TorreyPines Therapeutics to Present Tezampanel Phase IIb Clinical Data for Acute Migraine at 50th Annual Scientific Meeting of the American Headache Society
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2015)... , May 21, 2015 /PRNewswire/ - RepliCel ... clinical stage regenerative medicine company focused on the ... upcoming poster presentation at the International Society for ... for chronic Achilles tendinosis currently in a Phase ... May 29 th from 5:30 PM to ...
(Date:5/21/2015)... King of Prussia, PA (PRWEB) May 21, 2015 ... that Julia O’Neill has joined the firm as senior ... more than 30 years of experience in the management ... the vaccines, biologics, pharmaceutical and chemical industries. , “We’re ... enhance our longstanding capabilities in data analytics,” said Dr. ...
(Date:5/20/2015)... and Markets ( http://www.researchandmarkets.com/research/x4b7kw/top_technologies ) has announced ... Insights" report to their offering. Technical ... the Health and Wellness sector and has identified top ... in the year 2015. The research service provides an ... wellness technologies that are anticipated to have the highest ...
(Date:5/20/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/qfxkcq/global_cell ) has ... Market Outlook 2020 " report to their offering. ... regenerative medicine is expected to have huge marketing potential. ... in the growth of deregulated organs. Several therapeutic molecules ... to form new tissue or sometimes organ transplant is ...
Breaking Biology Technology:RepliCel to Present Unique Autologous Cell Treatment for Achilles Tendinosis at International Society for Cellular Therapy Conference 2RepliCel to Present Unique Autologous Cell Treatment for Achilles Tendinosis at International Society for Cellular Therapy Conference 3Julia O’Neill Joins Tunnell Consulting’s Operational and Process Improvement Practice 2Top Technologies in the Health and Wellness Industry 2015 2Global Cell Therapy Market Outlook 2015-2020 - 262 Cell Therapies & 13 Marketed Cell Therapies 2Global Cell Therapy Market Outlook 2015-2020 - 262 Cell Therapies & 13 Marketed Cell Therapies 3
... spotlight on the,ever-growing field of life sciences, Larta Institute,s ... in the midst of the dark backdrop of the,current ... to,focus on brilliant entrepreneurs in the life sciences, even ... years, through good,economic times and bad, the passion and ...
... 14 Access Pharmaceuticals, Inc.,(OTC Bulletin Board: ACCP) announced ... & Renshaw 5th Annual Global Healthcare Conference to be ... in Monte Carlo, Monaco.,Jeffrey B. Davis, CEO of Access ... 3:10 pm local time, 9:10 am Eastern time and ...
... May 14 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc.,("Oncolytics") ... has,received a letter of approval from the ... for its Clinical Trial Application (CTA),to begin ... administration of,REOLYSIN(R) in combination with paclitaxel and ...
Cached Biology Technology:Betting on Change - The Venture Forum in 2008 2Betting on Change - The Venture Forum in 2008 3Access Pharmaceuticals to Present at the Rodman & Renshaw 5th Annual Global Healthcare Conference 2Oncolytics Biotech Inc. Announces U.K. Phase II Clinical Trial Investigating REOLYSIN(R) in Combination with Paclitaxel and Carboplatin 2
(Date:5/20/2015)... , May 20, 2015 NXT-ID, Inc. ... that its wholly owned subsidiary, 3D-ID LLC, a company ... Team Battelle for the biometrics technology portion of the ... Contract from the Department of the Army. ... products developed for government, law enforcement and security agencies. ...
(Date:5/19/2015)... YORK , May 19, 2015  Technology is ... both internally and in the cloud. Passwords and their ... use of OTP and standards-based specifications such as those ... the outmoded use of passwords presents for BYOD, COPE, ... a unified biometric identity protocol. In ...
(Date:5/18/2015)... May 18, 2015 Fingerprint Cards (FPC) ... FPC1025, FPC1145, FPC1155 and FPC1035 from one if its module ... and including Q3 2015 and the sensors will be used ... order values for 2015 hereby amount to 740 MSEK to ... of 140 MSEK and a number of smaller orders not ...
Breaking Biology News(10 mins):NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 2NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 3HYPR Corp. Biometric Security Integration Kit Shields Applications and Devices Across the Internet of Things 2HYPR Corp. Biometric Security Integration Kit Shields Applications and Devices Across the Internet of Things 3Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 230 Million and Raises Revenue Guidance for 2015 2
... crop in prehistoric North and Central America. Now it appears ... American diet for much longer than previously thought, according to ... together the ancient history of plant domestication in the New ... advanced online edition of the Proceedings of the National Academy ...
... vitro fertilization (IVF) methods are painfully aware that timing is ... sick days taken from work, and the necessity to plan ... Aviv University study, trying for a baby has just been ... the same pill used to prevent pregnancy can actually help ...
... Over two hundred million humans depend for their subsistence on ... - and orders its partners, the symbiotic algae, to make ... delicate and complex partnerships a collaboration now facing grave ... a primitive animal and zooxanthellae, tiny one-celled plants, is ...
Cached Biology News:Corn's roots dig deeper into South America 2The surprising power of the pill 2Coral's addiction to 'junk food' 2Coral's addiction to 'junk food' 3
... DALTsix Gradient Maker, 1. Modular system ... 2-D electrophoresis.Run up to six lab-cast ... cm) simultaneously.Use with 18- or 24-cm ... pre-assembled hinged gel cassettes.Innovative design simplifies ...
albumin from bovine serum (BSA), 2,4-dinitrophenylated (DNP-BSA)...
albumin from bovine serum (BSA), Alexa Fluor® 647 conjugate...
albumin from bovine serum (BSA), tetramethylrhodamine conjugate...
Biology Products: