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:10/22/2014)... SANTA CLARA, Calif. , Oct. 22, 2014 /PRNewswire/ ... today announced the introduction of the cQUB™-1 (cQuest Ultrasound ... cQUB white-label ultrasound systems designed and manufactured by Cephasonics ... brand name and model number. Cephasonics will be showcasing ... 2014 being held this week in Chongqing, ...
(Date:10/22/2014)... , Oct. 22, 2014  Quest Diagnostics (NYSE: ... information services, today announced that its Board of Directors ... a director, effective December 1, 2014. Including Dr. Leiden, ... is the Chairman, President and CEO of Vertex Pharmaceuticals. ... scientific and commercial experience in the pharmaceutical and biotechnology ...
(Date:10/22/2014)... Calif. , Oct 22, 2014 Antigen ... Irvine, California , announced the receipt of ... Business Innovation Research award (SBIR) from the National Institute of Dental ... fund the development of a Pan-HIV Protein Microarray Chip, ... HIV-1 and HIV-2 subtypes and aid in the development ...
Breaking Medicine Technology:Cephasonics Launches the cQUB-1, First Product in New Family of cQUB White-Label Ultrasound Systems Targeted at Medical Applications 2Cephasonics Launches the cQUB-1, First Product in New Family of cQUB White-Label Ultrasound Systems Targeted at Medical Applications 3Quest Diagnostics Adds Jeffrey M. Leiden, M.D., Ph.D., to Board of Directors 2Quest Diagnostics Adds Jeffrey M. Leiden, M.D., Ph.D., to Board of Directors 3Biomarker Discovery Company, Antigen Discovery Inc., Awarded an NIH Phase I Small Business Innovation Research Grant to Develop a Pan-HIV Protein Microarray Chip 2
... Oct. 13 The Care Continuum Alliance ... Award for the "Greatest Impact on Health" at ...  The ALL/PHASE protocol, which utilizes low-cost and generic medications ... successfully implemented in Kaiser Permanente communities, including those served ...
... Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna -- OOSTERHOUT, Netherlands, Oct. 13 ... ... (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... var s = ,; var first_result; // Results are keyed by longUrl, so we need to grab the ...
Cached Medicine Technology:Kaiser Permanente's ALL/PHASE Initiative Wins 2010 Care Continuum Alliance Quality Impact Award for Greatest Impact on Health 2Kaiser Permanente's ALL/PHASE Initiative Wins 2010 Care Continuum Alliance Quality Impact Award for Greatest Impact on Health 3Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 2Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 3Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 4Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 5Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 6Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 7Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 8Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna 9
(Date:10/25/2014)... Background: , In 1998 Bob Savage founded the ... in the field of establishing recovery community organizations. Bob ... when he retired, he set out to answer a couple ... , 1. Where are the people in recovery ... 2. Can the recovery community be organized to advocate for ...
(Date:10/25/2014)... The Wehrman Collaborative, LLC ... for disabled users by disabled users, has granted ... Mackin Educational Resources of Burnsville, Minnesota, for their ... to the Minnesota Alliance for Patient Safety of ... website. Both organizations have met WeCo’s ...
(Date:10/25/2014)... QueenBeeTickets.com has a variety of tickets for ... prices. Bob Seger & The Silver Bullet Band tickets ... are going on sale October 25 and are expected ... browse the selection of tickets for Bob Seger & ... singer is touring North America beginning next month, and ...
(Date:10/25/2014)... York (PRWEB) October 25, 2014 ... lawsuits ( http://www.vaginalmeshlawsuit2015.com/ ) filed against Boston ... in U.S. District Court, Southern District of West ... Judgment on Punitive Damages in a group of ... a ruling issued on October 21st, U.S. District ...
(Date:10/25/2014)... Limbkeepers® announced today that they will be featured ... Jr, airing 1st QTR 2015 via Discovery Channel. Dates ... will focus on Limbkeepers® non compression knit sleeves, a ... arms, hands, and legs from abrasion, skin tears and ... help reduce injuries, allow for continued daily activities, and ...
Breaking Medicine News(10 mins):Health News:CCAR Accepting Nominations for the Bob Savage Recovery Advocate of the Year Award 2Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 2Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 3Health News:QueenBeeTickets.com Features Bob Seger & The Silver Bullet Band Tickets for Charleston Civic Center, Huntington Center, and Nationwide Arena at Reduced Prices 2Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 3Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 4Health News:Upcoming Episode of Innovations with Ed Begley, Jr. to Feature Limbkeepers® 2
... It was a "common sense" decision to start the ... of the stroke belt. , "We wanted to give better ... of the Department of Neurology at the Medical College of ... 2000 and Hess and his colleagues were frustrated that nearly ...
... Researchers at UT Southwestern Medical Center have developed what ... new imaging technique to diagnose brain tumors. The unique test ... are located in areas of the brain too dangerous to ... a definitive diagnosis of cancer based on imaging of a ...
... , THURSDAY, Jan. 26 (HealthDay News) -- Popular cholesterol-lowering statins may ... a new study shows. Hepatitis B, an inflammation of the liver ... causes of liver cancer. This is not the first ... Other studies have hinted that these drugs may play a role ...
... (HealthDay News) -- Positive reinforcement, such as receiving small, ... seems to help patients with high blood pressure take ... of black Americans. The findings are significant because ... and death, the researchers from the Center for Healthful ...
... lung clearance index (LCI) is a sensitive non-invasive marker of ... according to a new study from Australian researchers. "We ... especially in the presence of airway inflammation and Pseudomonas aeruginosa," ... the Sydney Children,s Hospital. "LCI may not only be a ...
... Reporter , THURSDAY, Jan. 26 (HealthDay News) -- The rate ... dramatic upturn since 2004, reversing a trend of decline throughout ... place outside of the traditional hospital setting increased 29 percent ... to 0.72 percent -- almost 30,000 births -- according to ...
Cached Medicine News:Health News:Georgia Bio honors biotech company that enables stroke care 2Health News:Georgia Bio honors biotech company that enables stroke care 3Health News:Diagnostic brain tumor test could revolutionize care of patients 2Health News:Statins May Stave Off Liver Cancer in People With Hepatitis B 2Health News:Positive Reinforcement May Help Patients Take Their Meds 2Health News:Early cystic fibrosis lung disease detected by bronchoalveolar lavage and lung clearance index 2Health News:More U.S. Babies Born at Home: Report 2Health News:More U.S. Babies Born at Home: Report 3
... The Aisys Carestation helps you deliver unmatched ... Aisys Carestation is the most complete anesthesia ... point of need - at your fingertips., ... our industry-leading Datex-Ohmeda legacy of anesthesia delivery ...
... Mesh LP is a super-light polypropylene mesh ... body reaction is reduced considerably. Optilene Mesh ... all open hernia repair procedures. It perfectly ... flexibility Optilene Mesh LP adapts to the ...
... Optilene Mesh Elastic is a lightweight and ... elasticity the mesh is able to adapt to ... The new honeycomb like structure with the large ... elastic scar. The mesh is ideal for incisional ...
... LP is a lightweight polypropylene mesh ... considerably reduced,foreign body reaction. The softer, ... It perfectly conforms to,anatomical structures. Due ... LP adapts to the movements of ...
Medicine Products: