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In brief ...(Stem Cell Therapeutics )
In brief ...
* Cardiome Pharma (Vancouver) said interim results from its Phase IIb trial with oral vernakalant to prevent recurrence of atrial fibrillation (AF), originally due in 4Q07, will not be disclosed until March of 2008, with final data in the middle of the next year. By delaying the data for one quarter, Cardiome expects to add roughly 20% more patients into the interim analysis than originally planned, making more data available on patients with longer-term exposure...
* CV Therapeutics (Palo Alto, California) reported that the FDA will review a supplemental new drug application claiming potential anti-arrhythmic benefit for Ranexa (ranolazine extended-release tablets). Ranexa is approved for second-line use in chronic angina, and the FDA is reviewing an sNDA seeking to expand the label to first-line use in angina as well as an NDA seeking to add a claim of reduction of hemoglobin A1c in coronary artery disease patients with diabetes. The expected action date for the two sNDAs and the NDA is July 27, 2008...
* Stem Cell Therapeutics (Calgary) has received a "no objection" letter from Health Canada for the REGENESIS trial, a Phase II prospective, randomized, double-blind, placebo-controlled study of NTx-265, a human chorionic gonadotropin and epoetin alfa in acute ischemic stroke patients investigation efficacy/safety endpoints. The ...
- Stem Cell Therapeutics Corp. Announces Enrollment of First Patient in the...
- News wire article from: Marketwire Canada August 11, 2009 700+ words
...COMTEX) -- Stem Cell Therapeutics Corp. ("SCT...modified REGENESIS Phase IIb acute ischemic...the modified Phase IIb clinical stroke...modified REGENESIS Phase IIb acute ischemic...About Stem Cell Therapeutics Corp.: Stem...
- Stem Cell Therapeutics Receives Clearance from Health Canada to Proceed with...
- News wire article from: Marketwire Canada July 20, 2009 700+ words
...Marketwire via COMTEX) -- Stem Cell Therapeutics Corp. (TSX VENTURE:SSS...protocol using NTx(R)-265 for a Phase IIb clinical trial treating acute...on May 15, 2009. About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics...
- Stem Cell Therapeutics Corp. Receives Green Light to Begin Enrolling Patients...
- News wire article from: Marketwire Canada July 21, 2009 700+ words
...COMTEX) -- Stem Cell Therapeutics Corp. ("SCT...initiate the Phase IIb acute ischemic...protocol for the Phase IIb clinical trial...controlled Phase IIb stroke study...About Stem Cell Therapeutics Corp.: Stem...
- Alexion Begins Large Phase IIb Clinical Trial of C5 Inhibitor for Bypass...
- Press release article from: PR Newswire January 13, 1999 700+ words
...bypass graft (CABG) surgery in a Phase IIb clinical trial of its lead anti...completed studies." The new Phase IIb study will test two dosages of...Complement Inhibitors and Apogen T-Cell Therapeutics which together target severe cardiovascular...
- Inflazyme Pharmaceuticals Proceeds With Clinical Phase IIb Asthma Study With...
- Press release article from: Business Wire December 21, 2005 700+ words
...announced today it is proceeding with its Phase IIb clinical study in Q1 2006 with IPL512...medication for the control of asthma. The Phase IIb study is an international study being...pleased to be taking IPL512,602 into a Phase IIb clinical study in persistent asthma in...
- AltaRex Submits IND Amendment to Initiate Second Phase IIb Trial Of OvaRex(TM)...
- Press release article from: PR Newswire November 4, 1998 700+ words
...Updates Clinical Progress on Ongoing Phase IIb Trial - WALTHAM, Mass., Nov. 4...conduct a second potentially pivotal Phase IIb clinical trial of its lead product...commence the study. "This second U.S. Phase IIb study complements our ongoing Phase IIb...
- CytRx Initiates Phase IIb Efficacy Clinical Trial with Arimoclomol for...
- Press release article from: Business Wire December 20, 2007 700+ words
...initiated screening volunteers in its Phase IIb clinical trial with arimoclomol for the...probability of measuring efficacy in the Phase IIb clinical trial, including administering...added Mr. Kriegsman. About the Phase IIb Trial in ALS In the randomized Phase...
- Valentis Announces Favorable Interim Phase IIb Analysis, Efficacy Results on...
- Press release article from: PR Newswire January 10, 2006 700+ words
...group assumptions are correct in VLTS 934 Phase IIb peripheral arterial disease trial...favorable interim results in its VLTS 934 Phase IIb clinical trial in peripheral arterial...statisticians confirmed the VLTS 934 Phase IIb placebo group assumptions. The interim...
Source: HighBeam Research, In brief ...(Stem Cell Therapeutics )