Valentis
Introduces New Gene Delivery Systems
for Secreted Proteins
January 10, 2000 Burlingame, CA — Valentis, Inc.
(NASDAQ:
VLTS)
today announced at the Hambrecht & Quist
Healthcare Conference in San Francisco that
it is extending its product line by
developing gene delivery systems for
secreted proteins. This new product area
incorporates Valentisí novel PINCô
(Protective, Interactive, Non-Condensing)
polymer muscle delivery system, which is
enhanced by electroporation, the application
of an electrical current through the site of
injection. Because the muscle is used to
produce therapeutic proteins that are
secreted into the bloodstream, this delivery
system is applicable to any protein for
which long-term systemic administration is
desired. The Company also announced its
GeneSwitchô gene regulation system would
be incorporated into some of the secreted
protein products to provide precise control
over the level and duration of gene
expression. The Company believes the
resulting products will provide long-term
expression of therapeutic proteins at
controllable levels with low manufacturing
costs, the ability to redose, and normal
storage characteristics.
The
first two genes for which delivery systems
are being developed are Factor IX for
hemophilia B and erythropoeitin for anemia.
Following the administration of the
therapeutic gene into the muscle,
electroporation is applied to the injection
site. This increases the uptake of the gene
into the muscle cells and results in more
than a one hundred-fold increase in protein
production. Electroporation is being
developed through a collaboration with
Genetronics, a San Diego company. By
incorporation of the GeneSwitchô, gene
expression is turned on by administration of
an orally bioavailable drug in a dose
dependent manner.
"This
is an exciting new area of product
development for Valentis," said
Benjamin F. McGraw, President and CEO of
Valentis. "The current market for
secreted proteins is over $9 billion. We
believe our gene delivery systems can
improve both the safety profile and the
frequency of administration of these
products. In addition, our initial market
research study found that 87% of
nephrologists surveyed saw a place for an
EPO-GeneSwitchô product in their practice
and 72% of oncologists surveyed responded
that they would definitely use an
EPO-GeneSwitchô product.
In
other developments, Valentis noted that
because of unexpected delays at a contract
laboratory, preclinical work on BRCA1 for
breast and ovarian cancer would not be
completed until the second quarter of 2000.
The contract between Valentis and Eli Lilly
has been extended through May 2000 to allow
for the completion of the preclinical work.
Valentis,
Inc. (resulting from the combination of
Megabios, Corp., GeneMedicine, Inc. and
PolyMASC Pharmaceuticals plc) is a leader in
the field of biologics delivery. The Company
develops proprietary technologies and
applies its preclinical and early clinical
development expertise to create novel
therapeutics. The Companyís core
technologies include multiple gene delivery
and gene expression systems and PEGylation
technologies designed to improve the
safety, efficacy and dosing characteristics
of genes, proteins, peptides,
peptidomimetics, antibodies and replicating
and non-replicating viruses.
These
technologies are covered by a broad patent
portfolio that includes issued U.S. and
European claims. Valentis' commercial
strategy is to enter into corporate
collaborations for full-scale clinical
development and marketing and sales of
products. Valentis itself, or through its
wholly-owned subsidiary PolyMASC
Pharmaceuticals, currently has corporate
collaborations with Roche Holdings, Eli
Lilly, and Glaxo Wellcome, Transkaryotic
Therapies, Onyx Pharmaceuticals and Bayer
International, and a manufacturing
partnership with DSM Biologics and Qiagen
N.V. Additional information about Valentis
and PolyMASC can be found at www.valentis.com
and www.polymasc.com.
Statements
in this press release that are not strictly
historical are "forward looking"
statements as defined in the Private
Securities Litigation Reform Act of 1995.
There can be no assurance that Valentis will
be able to develop a commercially viable
gene-based therapeutic, that any of its
programs will be partnered with a
pharmaceutical partner, that necessary
regulatory approvals will be obtained, or
that any clinical trials will be successful.
The actual results may differ from those
projected in the forward-looking statement
due to risks and uncertainties that exist in
the Company's operations and business
environment. These are described more fully
in the Valentis Annual Report on Form 10-K for the
period ended June 30, 1999 and
quarterly report on Form 10-Q for the period
ended September 30, 1999 filed with the
Securities and Exchange Commission.
