Transgene Moves Forward Its Vaccine Candidate MVA-HPV-IL2 In A Novel Approach Against Pre-Cancerous Cervical Lesions
30 Noviembre 2004 - 10:34AM
PR Newswire (US)
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
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