Navigation Links
Favrille Announces Results from Phase 3 Registration Trial of Specifid in Patients with Follicular B-Cell Non-Hodgkin's Lymphoma
Date:5/27/2008

Results Fail to Show Statistically Significant Improvement in Primary

Endpoint, Time to Progression, Compared to Control

SAN DIEGO, May 27 /PRNewswire-FirstCall/ -- Favrille, Inc. (Nasdaq: FVRL) today announced results from the Company's Phase 3 registration trial of Specifid(TM) following Rituxan(R) in patients with follicular B-cell non-Hodgkin's lymphoma (NHL).

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

Analysis of time to progression (TTP), the primary endpoint in the trial, failed to show a statistically significant improvement in the treatment arm, Specifid plus Leukine(R) (sargramostim, GM-CSF) following Rituxan, compared to the control arm, placebo plus Leukine following Rituxan. Analysis of all subgroups also did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors.

The safety profile was comparable between the two arms and consistent with what has been observed in previous Specifid trials. Most adverse events reported in the trial were of low grade.

"We are clearly very disappointed with the data from this trial, particularly on behalf of the patients and their families," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "Based on these results, we are discontinuing development of Specifid and are currently evaluating steps to conserve cash and recognize value on our assets. We wish to thank all of our employees and the patients, clinical investigators and trial coordinators for their support and dedication."

About the Phase 3 Registration Trial

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. 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. The trial was conducted at 67 centers in the U.S.

Conference Call and Webcast

Favrille's management team will host a conference call today at 8:30 a.m. Eastern Time to discuss the information contained in this press release. A live audio webcast will be available on the Investor Relations section of the Company's web site at http://www.favrille.com . Alternatively, callers may participate in the conference call by dialing (866) 831-6267 or (617) 213-8857, passcode 99549869. A telephone replay of the call will also be available for 48 hours. The telephone replay can be accessed by dialing (888) 286-8010 or (617) 801-6888, passcode 20389415.

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.

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 Favrille's ability to continue its operations, conserve cash or recognize value on our assets and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. 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 biology technology :

1. Favrille Reports First Quarter 2008 Financial Results
2. Favrille to Host Conference Call and Live Webcast to Discuss First Quarter 2008 Financial Results on May 8, 2008
3. Favrille Reports Fourth Quarter and Year End 2007 Financial Results
4. Favrille Announces $21.1 Million Registered Direct Offering
5. Favrille to Present at BIOCOM Investor Conference, Acumen BioFin Rodman & Renshaw Healthcare Conference and CIBC World Markets Healthcare Conference
6. Favrille to Host Conference Call and Live Webcast to Discuss Third Quarter 2007 Financial Results on October 25, 2007
7. Favrille to Present at BIO InvestorForum
8. Favrille to Present at AG Edwards Emerging Growth Conference and Wall Street Analyst Forum
9. Favrille CEO to Present at Bear Stearns Healthcare Conference
10. Favrille CEO to Present at NewsMakers in the Biotech Industry Investment Conference
11. Dragon Pharma Announces June 26, 2008 for 2008 Annual Shareholders Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... Sciences today announced the three Winners and six Finalists of the 2017 Blavatnik ... annually by the Blavatnik Family Foundation and administered by the New York Academy ...
(Date:10/12/2017)... ... , ... AMRI, a global contract research, development and manufacturing ... and quality of life, will now be offering its impurity solutions as a ... requirements for all new drug products, including the finalization of ICH M7 earlier ...
(Date:10/11/2017)... Wayne. NJ (PRWEB) , ... October 11, 2017 , ... Personal eye wash is a ... rinse one eye at a time. So which eye do you rinse first if a ... you have Plum Duo Eye Wash with its unique dual eye piece. , ...
(Date:10/11/2017)... the Netherlands and LAGUNA HILLS, Calif. ... The Institute of Cancer Research, London ... use MMprofiler™ with SKY92, SkylineDx,s prognostic tool to risk-stratify patients ... trial known as MUK nine . The University of ... trial, which is partly funded by Myeloma UK, and ICR ...
Breaking Biology Technology:
(Date:4/19/2017)... The global military biometrics market ... by the presence of several large global players. The ... major players - 3M Cogent, NEC Corporation, M2SYS Technology, ... 61% of the global military biometric market in 2016. ... military biometrics market boast global presence, which has catapulted ...
(Date:4/13/2017)... India , April 13, 2017 According to ... Proofing, Identity Authentication, Identity Analytics, Identity Administration, and Authorization), Service, Authentication Type, ... MarketsandMarkets™, the IAM Market is expected to grow from USD 14.30 Billion ... Growth Rate (CAGR) of 17.3%. ... MarketsandMarkets ...
(Date:4/11/2017)... 11, 2017 NXT-ID, Inc. (NASDAQ:   ... announces the appointment of independent Directors Mr. Robin D. ... Board of Directors, furthering the company,s corporate governance and expertise. ... Gino Pereira , ... forward to their guidance and benefiting from their considerable expertise ...
Breaking Biology News(10 mins):