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

SAN DIEGO, April 9, 2008 /PRNewswire-FirstCall/ -- Favrille, Inc. (Nasdaq: FVRL), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced today that it has reached the data cutoff date for the Company's Phase 3 registration trial of Specifid(TM) (mitumprotimut-T, formerly FavId(R)) following Rituxan(R) in patients with follicular B-cell non-Hodgkin's lymphoma (NHL). As of the data cutoff date, 205 of the 349 patients randomized have experienced disease progression (relapsed) according to investigator determination. Final analysis will be based on a central radiology assessment of the patients' CT scans. Unblinding of the data is expected to occur in June 2008.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080404/LAF521LOGO)

Median follow-up for ongoing patients is 31 months from randomization (range 21 to 41 months), or approximately 34 months from the initiation of Rituxan treatment (range 24 to 44 months). Based on the protocol's assumptions, this range of follow-up would provide sufficient power to detect a significant difference between the two arms for time to progression (TTP), the primary endpoint in the trial.

"We believe the design and execution of this registration trial have positioned us well for success," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "Based on the status of patients at data cutoff and our assumptions about the behavior of the control arm in this trial, we are very encouraged that the upcoming analysis will provide an outcome which is both clinically and statistically significant. Our clinical and biometrics 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 to boost immune responses. Favrille's unique and proprietary manufacturing process, which includes an insect cell (baculovirus) expression system, allows for the manufacture of Specifid for delivery to patients in as few as eight weeks. Data presented at the American Society of Hematology Annual Meeting in December 2007 showed that Id-KLH produced via insect cells results in a more immunogenic response compared to Id-KLH produced in a traditional mammalian cell manufacturing process. Also, unlike other Id-KLH active immunotherapies in development, Specifid is intended for use as a chronic therapy and is administered until the patient's disease progresses.

About Favrille, Inc.

Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, Specifid (mitumprotimut-T, formerly FavId), is a patient-specific, active immunotherapy based upon unique genetic information extracted from a patient's tumor. Specifid is currently under investigation in a Phase 3 registration trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of cutaneous T-cell lymphoma.

The preliminary, blinded clinical data reported from time to time prior to the release of the final results of Favrille's Phase 3 registration trial have not been audited and have been taken from databases that have not been reconciled against medical records kept at the clinical sites or that may not include the most current information on patient disease progressions. The data released may not be indicative of the final results of Favrille's Phase 3 registration trial Failure can occur at any stage of testing. The Company does not know whether its Phase 3 registration trial or any future clinical trials will demonstrate safety and efficacy sufficient to result in marketable products. Favrille's failure to adequately demonstrate the safety and efficacy of Specifid will prevent the Company from obtaining regulatory approval for, or commercializing, Specifid.

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Favrille's product candidates, proprietary technologies and research and clinical development programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to progress and timing of clinical trials for Specifid, including difficulties or delays in development, testing, manufacturing and marketing Specifid or Favrille's other product candidates; delays in the availability of data from Favrille's Phase 3 clinical trial; Favrille's ability to obtain marketing approval for Specifid or Favrille's other product candidates and the timing of any such approvals, including whether it will receive expedited review as a result of the Fast Track designation; Favrille's ability to manufacture sufficient quantities of Specifid for use in clinical trials and, if Specifid receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using Specifid; Favrille's ability to obtain additional financing to support its operations; and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. In addition, conclusions regarding the safety and efficacy of Favrille's product candidates cannot be made until the results of future clinical trials of longer duration in more patients are known. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.


'/>"/>
SOURCE Favrille, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:6/24/2016)... , June 24, 2016  Consumers have taken ... regulators/payers have placed more emphasis on patient outcomes. ... support programs in the pharmaceutical industry have evolved ... Consequently, pharmaceutical companies are focusing on becoming more ... providing products and services that improve health. ...
(Date:6/24/2016)... 24, 2016  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: ... novel therapeutics for the treatment of grievous blood-based ... closing of its previously announced underwritten public offering ... public offering price of $18.75 per share. All ... by GBT. GBT estimates net proceeds from the ...
(Date:6/24/2016)... Dublin ... of the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global ... including its applications in various applications. The report deals ... three main industries: pharmaceutical and biotechnology, food and beverage, ...
Breaking Medicine Technology:
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
Breaking Medicine News(10 mins):