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Transgene Moves Forward Its Vaccine Candidate MVA-HPV-IL2 In A
Novel Approach Against Pre-Cancerous Cervical Lesions
STRASBOURG, France, Nov. 30 /PRNewswire-FirstCall/ -- Transgene (Nasdaq:
TRGNY; Euronext: FR0005175080) announced today that it is conducting a new
Phase II clinical trial with its vaccine candidate MVA-HPV-IL2 in women
diagnosed with pre-cancerous lesions of the cervix (cervical intraepithelial
neoplasia - CIN 2/3) related to type-16 human papillomavirus (HPV16). Based on
the favorable data obtained from the previous Phase II trial that was conducted
on CIN 2/3, this newly approved trial will evaluate the efficacy of MVA-HPV-IL2
after a 6-month observation period, which will give patients longer time to
mount an immune response.
The first Phase II trial included 31 patients with HPV16-related CIN 2/3, 29 of
which were evaluable for product efficacy. The patients were randomized into
two subgroups for the evaluation of two different doses (5.10(5) pfu and
5.10(7) pfu) of the vaccine candidate. Per the trial's protocol, the patients
underwent surgical removal of the lesions (conisation) six weeks after
vaccination. While no indication of CIN 2/3 regression was shown in the
patients treated with the low dose of the vaccine, responses were documented
after only six weeks in seven out of 16 patients in the high dose group.
Responses were measured in the form of lesion-grade or -size reduction through
histology analysis (five patients) and/or viral clearance (four patients).
The new trial is being conducted at six centers in France. Candidate enrollment
is on-going and preliminary data are expected during the second half of 2005.
18 patients with HPV16-related CIN2/3 will receive three injections of the
high-dose vaccine (5.10(7) pfu) administered sub- cutaneously. They will be
monitored every 2 months for 6 months with colposcopy, virology, cytology and
possibly histology controls. Only those still presenting with a CIN2/3 or an
HPV infection at the end of the 6-month period will undergo a conisation. The
other patients will be considered as having responded to the therapeutic
vaccination and will not be considered to require conisation. They will
continue to be monitored to ensure that the regression is complete and
long-lasting.
"Every year, 165,000 women in the U.S. and Europe are diagnosed with
HPV16-related CIN 2/3," stated Dr. Patrick Squiban, Vice-President, Medical and
Regulatory Affairs of Transgene. "We believe that an effective therapeutic
vaccination against HPV16 constitutes a novel approach that may offer an
alternative to conisation in the future."
About MVA-HPV-IL2 cancer vaccine
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 a Phase I clinical trial. Transgene's proprietary vector
technology platform consists of adenoviral and poxviral families.
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 against CIN 2/3 and HPV infection. 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 may not
have sufficient resources to complete on-going clinical trials and continue its
research and development activities after mid-2005, 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, 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 under "Risk Factors" and elsewhere in Transgene's
Annual Report on Form 20-F for the year ended December 31, 2003 filed with, and
in its Reports on Form 6-K furnished to, the U.S. Securities and Exchange
Commission.
DATASOURCE: Transgene
CONTACT: Patrick Squiban of Transgene, VP, Medical & Regulatory Affairs,
+33-3-88-27-91-73; or Michael Long of Cohn & Wolfe, +1-415-365-8523, for
Transgene; or Estelle Guillot-Tantay, +33-1-53-70-74-93, or Laurence
Heilbronn, +33-1-53-70-74-64, both of Image 7, for Transgene