Medindia LOGIN REGISTER
Medindia
Advertisement

Favrille Announces Results from Phase 3 Registration Trial of Specifid in Patients with Follicular B-Cell Non-Hodgkin's Lymphoma

Tuesday, May 27, 2008 General News
Advertisement
SAN DIEGO, May 27 Favrille, Inc. (Nasdaq: FVRL)today announced results from the Company's Phase 3 registration trial ofSpecifid(TM) following Rituxan(R) in patients with follicular B-cellnon-Hodgkin's lymphoma (NHL).
Advertisement

(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 tothe control arm, placebo plus Leukine following Rituxan. Analysis of allsubgroups also did not show any significant differences in primary orsecondary endpoints when adjusted for prognostic factors.
Advertisement

The safety profile was comparable between the two arms and consistent withwhat has been observed in previous Specifid trials. Most adverse eventsreported 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. "Basedon these results, we are discontinuing development of Specifid and arecurrently evaluating steps to conserve cash and recognize value on our assets.We wish to thank all of our employees and the patients, clinical investigatorsand 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 July2004. The Company completed enrollment in January 2006 with 349 patientsrandomized into the trial. The trial was open to both treatment-naive andpreviously treated patients, ultimately enrolling a much largertreatment-naive population (78%). Patients were randomized at aone-to-one ratio to receive either Specifid or placebo following a standardcourse 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. Alive audio webcast will be available on the Investor Relations section of theCompany's web site at www.favrille.com . Alternatively, callers mayparticipate in the conference call by dialing (866) 831-6267 or(617) 213-8857, passcode 99549869. A telephone replay of the call will also beavailable 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 developmentand commercialization of targeted immunotherapies for the treatment of cancerand other diseases of the immune system.

Statements in this press release that are not strictly historical innature constitute "forward-looking statements." Such statements include, butare not limited to, references to Favrille's product candidates, proprietarytechnologies and research and clinical development programs. Suchforward-looking statements involve known and unknown risks, uncertainties andother factors that may cause Favrille's actual results to be materiallydifferent from historical results or from any results expressed or implied bysuch forward-looking statements. These factors include, but are not limitedto, risks and uncertainties related to Favrille's ability to continue itsoperations, conserve cash or recognize value on our assets and additionalrisks discussed in Favrille's filings with the Securities and ExchangeCommission. All forward-looking statements are qualified in their entirety bythis cautionary statement. Favrille is providing this information as of thedate of this release and, except as required by law, does not undertake anyobligation to update any forward-look
Sponsored Post and Backlink Submission


Latest Press Release on General News

This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close