Biotech News - Favrille Announces FDA Allowance of Investigational New Drug Application for FAV

Favrille Announces FDA Allowance of Investigational New Drug
Application for FAV-201, a Patient-Specific Immunotherapy for T-Cell
Lymphoma
Thursday June 15, 6:30 am ET

SAN DIEGO, June 15 /PRNewswire-FirstCall/ -- Favrille, Inc. (Nasdaq:
FVRL - News), a biopharmaceutical company developing patient-
specific immunotherapies for the treatment of cancer, announced
today that its electronic Investigational New Drug (IND) application
for FAV-201, a patient-specific immunotherapy for the treatment of T-
cell lymphoma, has been cleared by the U.S. Food & Drug
Administration (FDA). Initially, FAV-201 will be evaluated in
cutaneous T-cell lymphoma (CTCL).
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"This new product candidate represents an extension of our platform
and draws on our success to date in the development of our lead
product candidate FavId® for the treatment of B-cell non-Hodgkin's
lymphoma (NHL)," said John P. Longenecker, Ph.D., President and
Chief Executive Officer of Favrille. "This regulatory clearance by
the FDA is an important milestone in the development of FAV-201 and
we look forward to introducing it in the clinic."

Favrille intends to initiate a Phase 1/2 clinical trial evaluating
the safety and biologic activity of FAV-201 in patients with CTCL.
The trial will build upon preclinical data that suggest activity of
an immunotherapy based on a T-cell receptor. The multi-center trial
is expected to enroll approximately 30 patients.

FAV-201 is a recombinant, patient-specific, T-cell receptor-based
immunotherapy designed to induce an active immune response against
the unique protein found on the surface of T-cells that constitute a
patient's lymphoma. Favrille uses a similar approach with its lead
product candidate FavId for the treatment of B-cell NHL. In January
the Company completed enrollment in a pivotal Phase 3 clinical trial
of FavId following induction therapy with Rituxan®, the current
standard of care. Favrille has received Fast Track designation from
the FDA for FavId.

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, FavId, is based upon unique
genetic information extracted from a patient's tumor. FavId is
currently under investigation in a pivotal Phase 3 clinical 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.

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 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
FavId or FAV-201, including difficulties or delays in development,
testing, manufacturing and marketing FavId, FAV-201 or Favrille's
other product candidates; Favrille's ability to obtain marketing
approval for FavId, FAV-201 or Favrille's other product candidates
and the timing of any such approvals; Favrille's ability to
manufacture sufficient quantities of FavId or FAV-201 for use in
clinical trials and, if FavId or FAV-201 receive marketing approval,
for commercialization; risks associated with achieving projected
operating metrics and financial performance or the anticipated
number of patients using FavId or FAV-201; potential delays in
patient enrollment; 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.

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Source: Favrille, Inc.

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