Transgene's MVA-HPV-IL2 Vaccine Shows Activity in Phase II Clinical Trial
18 March 2004 - 4:01PM
PR Newswire (US)
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
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