Navigation Links
Favrille Announces Data Cutoff for Phase 3 Registration Trial of Specifid; Data Analysis and Unblinding Expected in June
Date:4/9/2008

team is working diligently to gather the required information and prepare for the analysis and unblinding of the trial in June."

Favrille initiated its Phase 3 randomized, placebo-controlled, double-blind registration trial of Specifid for follicular B-cell NHL in July 2004. The Company completed enrollment in January 2006 with 349 patients randomized into the trial in a span of 18 months. The trial was open to both treatment-naive and previously treated patients, ultimately enrolling a much larger treatment-naive population (78%). Patients were randomized at a one-to-one ratio to receive either Specifid or placebo following a standard course of Rituxan. A total of 45 patients came off study and were permanently censored for reasons other than disease progression, 28 (8%) because Specifid was not produced and 17 (5%) for a variety of other reasons. The trial was conducted at 67 centers in the U.S. under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA). Specifid was also granted Fast Track status by the FDA in January 2006.

In October 2007 an independent Data Monitoring Board (DMB) conducted an administrative analysis of the unblinded control arm in the Phase 3 trial. The objective of this analysis, conducted in agreement with the FDA, was to assess the behavior of disease progression in the control arm in order to help determine the duration of follow-up needed prior to unblinding the trial. The outcome of this DMB analysis supported the rationale for the timing of data cutoff.

About Specifid

Specifid (mitumprotimut-T, formerly FavId) is a personalized, active immunotherapy designed to stimulate a patient's immune system to mount a specific and sustained response to the patient's cancer. Specifid is based upon a recombinant protein, called idiotype (Id), which is derived from genetic material obtained from a patient's own tumor, then conjugated to keyhole limpet hemocyanin (KLH), a protein commonly used
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. Favrille Provides Update on Timing of Analysis from Pivotal Phase 3 Clinical Trial; Reports Third Quarter 2007 Financial Results
2. Echo Therapeutics Announces Positive Results with the Prelude(TM) SkinPrep System, the Next-Generation Skin Permeation Medium for its Symphony(TM) Transdermal Continuous Glucose Monitoring System
3. Anesiva Announces Pivotal Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Total Knee Replacement
4. Parion Sciences Announces Phase I Clinical Results for Novel Dry Mouth Treatment
5. VIA Pharmaceuticals Announces Updated DSMB Safety Results for VIA-2291 Ongoing Phase 2 Clinical Program
6. Medarex Announces Ipilimumab Program Continues to Move Forward
7. EnVivo Pharmaceuticals Announces Initiation of Clinical Safety and Biomarker Study of Alpha-7 Nicotinic Agonist, EVP-6124, in Patients with Schizophrenia
8. CoAxia(TM) Announces $11.5M Equity Financing From Existing Investors
9. ISTA Pharmaceuticals Announces Results of Clinical Trial of Xibrom(TM) QD (Once-Daily) Formulation
10. CorMatrix(R) Announces Intramyocardial Injection of Emulsified ECM Technology(TM) Demonstrates Enhanced Angiogenesis and Improved Cardiac Function in a Preclinical Model
11. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... , Sept. 19, 2014 Five MinuteClinic walk-in medical clinics ... metropolitan area. Three clinics opened in Memphis ... A fourth clinic will be added in Springfield ... Bartlett is expected to open October 22.  MinuteClinic is ... the United States . The ...
(Date:9/19/2014)...  Lpath, Inc. (NASDAQ: LPTN ), ... today that it has entered into definitive agreements ... and 3,605,042 unregistered warrants in a registered direct ... share of common stock and one unregistered warrant ... will be $3.475.  The warrants have an exercise ...
(Date:9/19/2014)... Intarcia Therapeutics, Inc. today announced the presentation ... ITCA 650 (continuous subcutaneous delivery of exenatide) in type ... the 50 th Annual Meeting of the European ... the open-label, phase 3 FREEDOM-HBL (high baseline) trial showed ... poorly controlled type 2 diabetes. The results were presented ...
Breaking Medicine Technology:MinuteClinic Walk-in Medical Clinics Opening in Memphis 2MinuteClinic Walk-in Medical Clinics Opening in Memphis 3Lpath, Inc. Announces $12.5 Million Registered Direct Offering 2Lpath, Inc. Announces $12.5 Million Registered Direct Offering 3Intarcia Announces Presentation of Phase 3 Data at EASD Showing ITCA 650 Markedly Reduces Blood Sugar In Patients With Poorly Controlled Type 2 Diabetes 2Intarcia Announces Presentation of Phase 3 Data at EASD Showing ITCA 650 Markedly Reduces Blood Sugar In Patients With Poorly Controlled Type 2 Diabetes 3Intarcia Announces Presentation of Phase 3 Data at EASD Showing ITCA 650 Markedly Reduces Blood Sugar In Patients With Poorly Controlled Type 2 Diabetes 4
... 26, 2007 - A new study published ... ("A National Survey of,Physician-Industry Relationships") on the ... the need for,profession-wide and public policy reforms ... that the existing,voluntary PhRMA (Pharmaceutical Research and ...
... 2007 - Aeolus,Pharmaceuticals, Inc. (OTCBB:AOLS) announced today ... of the Journal of Neuroscience a study,by ... National Jewish,Medical and Research Center demonstrating that ... 11207, demonstrated,neuroprotection in an animal model of ...
Cached Medicine Technology:Ties Between Physicians and Drug Companies Still Too Strong: the,Prescription Project Offers Solutions to Prevent Conflicts of,Interest 2Study Demonstrating Aeolus Compound's Neuroprotection in,Parkinson's Disease Published in the Journal of Neuroscience 2Study Demonstrating Aeolus Compound's Neuroprotection in,Parkinson's Disease Published in the Journal of Neuroscience 3
(Date:9/21/2014)... 21, 2014 Discount-Dress.com, a ... has recently announced its decision to implement a new ... easier for ladies across the world. Furthermore, the company ... for ladies. , The new items come in ... discounted prices, up to 56 percent off. "We are ...
(Date:9/21/2014)... Rancho del Rio, Colorado (PRWEB) September 21, 2014 ... of Vail, Colorado, ten teams of disabled and able-bodied ... hand cycles, and completed a ropes course in pursuit ... Team Challenge from national non-profit World T.E.A.M. Sports, ... to participating athletes who successfully completed the three stage ...
(Date:9/21/2014)... Recently, BambooIndustry.com, an experienced producer of natural ... bamboo panels ( http://www.bambooindustry.com/products/bamboo-panel/ ). The company’s excellent panels ... are available at discounted prices now, from 10 to ... bamboo panels are available in many specifications; they ... of them is finely manufactured by qualified workers. They ...
(Date:9/21/2014)... (PRWEB) September 21, 2014 According to latest ... the highest birth rate since 1966 (10.5 births per 1,000 ... their early 40s has risen steadily by 2 percent per ... births to women aged 50 and over) also rose, the ... there were more than nine times as many first births ...
(Date:9/20/2014)... 2014 Diabetes Protocol , a ... is helping thousands of people learn how to naturally ... pills, or prescriptions has caught the attention of Shane ... currently tens of millions of people in the U.S. ... 2 diabetes, and unfortunately, big pharma makes a killing ...
Breaking Medicine News(10 mins):Health News:Discount-Dress.com Implements A New Shopping Cart Software And Provides New Beach Wedding Dresses 2Health News:Disabled Athletes Excel at World T.E.A.M. Sports’ Adventure Team Challenge 2Health News:Disabled Athletes Excel at World T.E.A.M. Sports’ Adventure Team Challenge 3Health News:Discounted Bamboo Panels For Sale At BambooIndustry.com 2Health News:Statistics Reveal That the Number of 'Older' First-Time Mothers Is Growing 2Health News:Statistics Reveal That the Number of 'Older' First-Time Mothers Is Growing 3Health News:Statistics Reveal That the Number of 'Older' First-Time Mothers Is Growing 4Health News:Diabetes Protocol: Review Exposes Kenneth Pullman’s Breakthrough Discovery About Diabetes Management 2
... 2,500, officials say, but most cases remain mild , , MONDAY, ... swine flu in the United States rose to more than ... the country most affected by the outbreak, according to World ... to the illness rose to three over the weekend, with ...
... 11 MedCath Corporation (Nasdaq: MDTH ... healthcare services, predominately the diagnosis and treatment of ... join its senior management team as Senior Vice ... MedCath hospitals located in Arizona, California, New Mexico ...
... be an invited panelist in the second annual SOA in Healthcare conference ... , ... Plano, Texas (PRWEB) May 11, 2009-- Corepoint Health,s CTO, Dave Shaver, ... conference to be held on June 2 - 4 in Chicago, Illinois. ...
... Hope Solution, a 501-C3 nonprofit organization, is announcing ... telethon at Sojourner-Douglass College , located in Baltimore ... from 12noon to 6pm, and will raise money to ... options and dietary supplements.To view the Multimedia News Release, ...
... Received $22.5 million from the sale of a mortgage ... of debt outstanding under warehouse line in March 2009 ... approximately $46 million.NEW YORK, May 11 Care Investment ... the "Company"), a real estate investment and finance company ...
... MOUNTAIN VIEW, Calif., May 11 Alexza Pharmaceuticals, ... corporate presentation will be webcast live during the Eighth Annual ... 3:30 p.m. Pacific Time. The presentation will be webcast ... access the live presentation via the Web, please go to ...
Cached Medicine News:Health News:U.S. Now Leads World in Swine Flu Cases 2Health News:U.S. Now Leads World in Swine Flu Cases 3Health News:U.S. Now Leads World in Swine Flu Cases 4Health News:U.S. Now Leads World in Swine Flu Cases 5Health News:U.S. Now Leads World in Swine Flu Cases 6Health News:U.S. Now Leads World in Swine Flu Cases 7Health News:U.S. Now Leads World in Swine Flu Cases 8Health News:U.S. Now Leads World in Swine Flu Cases 9Health News:U.S. Now Leads World in Swine Flu Cases 10Health News:U.S. Now Leads World in Swine Flu Cases 11Health News:David Covert to Join MedCath as Senior Vice President, Operations 2Health News:Corepoint Health CTO to Participate in Panel Discussion at the 2009 SOA in Healthcare Conference 2Health News:Corepoint Health CTO to Participate in Panel Discussion at the 2009 SOA in Healthcare Conference 3Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 2Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 3Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 4Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 5Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 6Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 7Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 8Health News:Care Investment Trust Inc. Announces First Quarter 2009 Results 9Health News:Alexza's Corporate Presentation to be Webcast at the Eighth Annual JMP Securities Research Conference 2Health News:Alexza's Corporate Presentation to be Webcast at the Eighth Annual JMP Securities Research Conference 3
Complete Blink-N-Clean lens drops cleans and clears lenses in a blink. It is a unique blend of gentle to the eye ingredients that conveniently cleans, clears and keeps lenses feeling comfortable thro...
Sensitive Eyes drops keep soft contact lenses moist....
Lens Plus Sterile Saline Solution...
... Rub formula is the most convenient multi-purpose ... in one bottle without the need to ... lenses and removes protein build-up when used ... contains Hydranate, a special ingredient that removes ...
Medicine Products: