Favrille, Inc. (Nasdaq:
FVRL) 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).
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.
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.
Favrille, Inc.
favrille
View drug information on Leukine; Rituxan.