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Transgene's MVA-HPV-IL2 Vaccine Shows Activity in Phase II Clinical Trial
STRASBOURG, France, March 18 /PRNewswire-FirstCall/ -- Transgene (Nasdaq:
TRGNY; Nouveau Marche: FR0005175080) announced today encouraging results from
the phase II clinical trial of its MVA-HPV-IL2 vaccine candidate in patients
with human papilloma virus (HPV)-related disease.
"The data we collected from our phase II program points to a very interesting
new approach to the treatment of HPV-related affections," stated Jean-Francois
Carmier, Chief Executive Officer of Transgene. "We believe in the potential of
our product candidate as a therapeutic vaccine and we are extending its
evaluation into both cervical dysplasia and the earlier stage of silent HPV
infection."
HPVis the most common sexually transmitted disease, infecting almost 300
million women worldwide. HPV type 16, one of the High-Risk HPV types (HR-HPV),
is responsible for more than half of all cervical cancers. Most infected people
spontaneously eliminate their viral infection within six to 12 months. Patients
who do not eliminate their virus and develop long-lasting HR-HPV infection are
at greatest risk of developing cervical cancer. Cervical cancer is the second
leading cause of cancer-related mortality by cancer in women worldwide, causing
about 470,000 deaths per year, 80% of which occur in under-developed countries.
In countries where screening programs are in place, the risk of cancer is
reduced because pre-cancerous, asymptomatic lesions such as High-Grade Cervical
Intraepithelial Neoplasia (CIN2/3) are detected and then excised by a surgical
procedure called conisation. The progression from silent, persistent HPV
infection to CIN2/3 and then to cervical cancer takes several years. Despite
the fact that spontaneous regression is possible at each step, cervical cancer
remains a serious health concern if all lesions are not detected and treated in
a timely manner. This provides a strong rationale for developing a therapeutic
vaccine to address pre-cancerous conditions from silent, persistent HPV
infections to CIN2/3 lesions. Due to the wider use of HPV testing, an
increasing number of women are being diagnosed with a HR-HPV infection, but no
anti-viral treatment is currently available. It has been calculated that over
one million women in Europe have long-lasting HPV infection that they could not
spontaneously eliminate within 6 to 12 months, and are thus at a higher risk of
suffering from high grade cervical dysplasia and laterfrom cancer. An
effective therapeutic vaccine that could prevent the occurrence of cervical
dysplasia in this population is thus desirable. Compared to the use of mass
prophylactic vaccination against HPV, this therapeutic vaccination would
specifically target the patients who were not able to eliminate spontaneously
their HPV infection.
A phase II clinical trial has been ongoing in France with MVA-HPV-IL2, which
includes up to 28 women with CIN2/3. The patients are divided into two groups
for the evaluation of two different doses (5.105 pfu and 5.107 pfu) administered
sub-cutaneously. Patients are treated with MVA-HPV-IL2 on days 1, 8 and 15, with
conisation performed at week 6. The trial's primary objective is to demonstrate
clinical and histological efficacy as measured by the elimination of the CIN
lesions at six weeks.
The analysis performed on 27 evaluable patients confirms the excellent tolerance
of the product candidate. In addition, partial clinical and/or histological
responses, associated in some cases with viral clearance, were observed in five
out of the 15 patients treated with the high dose, evidencing a dose-related
effect. No indication of CIN regression was observed in the 12 patients treated
with the low dose. These signsof early CIN regression at the high dose warrant
further evaluation of the clinical activity of MVA-HPV-IL2 in a setting that can
allow a prolonged period of observation before conisation. A new trial is being
submitted to test the highest dose and postpone surgery for up to six months
after administration.
Patrick Squiban, MD, Vice President, Regulatory and Medical Affairs, noted: "Our
approach is consistent with the recommendations of prominent HPV and cancer
researchers worldwide who have calledfor developing a therapeutic agent to
prevent progression through the various stages of HPV-related disease. We
believe that conducting a trial focused on the highest dose of MVA-HPV-IL2 and
delayed surgery is the right step toward achieving this goal."
MVA-HPV-IL2 was simultaneously tested in 20 patients with vulvar
intra-epithelial neoplasia (VIN3). Clinical results showed no significant
difference in the patients treated with the vaccine compared to the controlled
placebo group. In view of the dose-related effect seen in the CIN2/3 trial,
these results were probably due to the low dose used (5.106 pfu) and the
advanced stage of the disease of these patients.
About MVA-HPV-IL2
Transgene's MVA-HPV-IL2 product candidate uses the MVA virus to carry and
express two HPV antigens found in HPV 16, the E6 and E7 proteins. The new
generation MVA vector is a highly attenuated poxvirus that combines the
advantages of a strain extensively tested in humans as a smallpox vaccine with
the ability to stimulate a strong immune response to antigens. The sequence
coding for the cytokine interleukin 2 (IL-2) is included to help stimulate
specific T cell responses.
About Transgene
Transgene, based in Strasbourg, France, is a biopharmaceutical company dedicated
to the discovery and development of therapeutic vaccines, immunotherapy
products, and delivery technologies for the treatment of diseases for which
there is no cure or adequate treatment at present, with a focus on the treatment
of cancer. Transgene has five products in clinical development, two of which
are in Phase II clinical trials, two in Phase I/II and one that has completed
Phase I clinical trial. Transgene's proprietary vector technology platform
consists of adenovirus and poxvirus.
This press release contains forward-looking statements, including statements
regarding the efficacy and safety of and potential market for Transgene's
product candidates and prospects. Statements that are not historical facts are
based on Transgene's current expectations, beliefs, estimates, forecasts and
assumptions, including Transgene's expectations related to progress in the
clinical trials and Transgene's belief as to the potential of MVA-HPV-IL2 as a
treatment for HPV-related diseases. The statements contained in this release
are not guarantees of future performance and involve certain risks,
uncertainties and assumptions which are difficult to predict. Accordingly,
actual outcomes and results may differ materially from what is expressed in
those forward-looking statements. Important factors which may affect Transgene's
future operating results include the following: Transgene's product candidates
may not demonstrate therapeutic efficacy after initial promising results,
Transgene may be unable to obtain regulatory approval for its product
candidates, Transgene may be unable to conduct its clinical trials as quickly as
it has predicted, Transgene's clinical trials may not produce results sufficient
to justify further product development, Transgene may not have sufficient
resources to complete the research and commercialization of any of its product
candidates, competitors may develop technologies or products superior to
Transgene's technologies or products, Transgene may not be able to successfully
enforce the intellectual property rights in all jurisdictions relating to its
product candidates and other important factors described in Transgene's Annual
Report on Form 20-F for the year ended December 31, 2002 filed with the U.S.
Securities and Exchange Commission, including those factors described in the
section entitled "Risk Factors."
DATASOURCE: Transgene
CONTACT: Patrick Squiban, MD, VP Medical & Regulatory Affairs of
Transgene, +33-3-88-27-91-73; or Michael Long of Cohn & Wolfe,
+1-212-798-9775, for Transgene; or Estelle Guillot-Tantay or
Laurence Heilbronn, both of Image 7, +33-1-53-70-74-93, +33-1-53-70-74-64, for
Transgene