Transgene: New Strategy in Therapeutic Vaccines, MVA-Muc1-IL2 Meets Primary Endpoint in Lung Cancer Phase II
23 Febrero 2005 - 12:00AM
PR Newswire (US)
Transgene: New Strategy in Therapeutic Vaccines, MVA-Muc1-IL2 Meets
Primary Endpoint in Lung Cancer Phase II STRASBOURG, France, Feb.
23 /PRNewswire-FirstCall/ -- Transgene (Nasdaq: TRGNY; Eurolist
Paris: FR0005175080) presented today, along with its 2004 financial
results, its new strategic goals. Taking advantage of its
substantial technical know-how, Transgene has decided to
concentrate resources on a streamlined product portfolio both in
cancer and infectious diseases. The clinical development portfolio
will concentrate, for the time being, on the following three main
products: the anti-cancer vaccine MVA-Muc1-IL2 currently in a Phase
II trial for lung cancer; the therapeutic vaccine MVA- HPV-IL2
against Human Papilloma virus infection currently in a Phase II
clinical trial for cervical intraepithelial neoplasia; and the
anti-cancer immunotherapy product Ad-IFNgamma in a Phase I/II
clinical trial for primary cutaneous lymphoma. A new therapeutic
vaccine candidate, MVA-HPV, against the hepatitis C virus is
scheduled to enter a Phase I/II clinical trial within one year. The
development of Myodys(R) for the treatment of Duchenne/Becker's
muscular dystrophy will continue to be pursued under funding from
the French Association against Muscular Dystrophy (AFM). The
development of Transgene other product candidates, Ad-IL2 in Phase
I/II for the treatment of melanoma, MVA-FCU1 in pre-clinical stage
and MVA- Muc1-IL2 for the treatment of prostate and kidney cancers,
are suspended and will resume if and when external financing is
available. Research programs will address problems relating to
infectious diseases and expanding the technology platform will be
expanded beyond viral vectors. Transgene also plans in the future
to obtain more value from its biomanufacturing expertise and
facilities, especially through additional partnering and contracts
with third parties. "Our strategic focus aims at fulfilling out
commitment to keeping our 2005 cash burn at the level of fiscal
year 2004, i.e., 20.3M euro," stated Philippe Archinard, Chief
Executive Officer of Transgene. "The recent results from our
clinical trials with MVA-Muc1-IL2 in lung cancer and MVA-HPV-IL2
for the treatment of CIN2-3 are very encouraging. We had to suspend
MVA-Muc1-IL2 in prostate cancer despite good results of the vaccine
in this indication. We are in the process of preparing and
discussing a pivotal trial for Ad-IFNgamma in cutaneous lymphoma
with the FDA and the European Medicines Agency (EMEA). In 2005, our
new strategy will mark a new step forward in the progress of our
product portfolio. We believe that the expected wealth of news from
anticipated portfolio developments in 2005 should raise our
visibility with investors." MVA-Muc1-IL2 therapeutic vaccine meets
primary endpoint in Phase II trial for the treatment in non-small
cell lung cancer. The multicentric phase II trial is evaluating the
efficacy of the upfront association of subcutaneous injections of
MVA-Muc1-IL2 at a dose of 10(8) pfu with a
cisplatin/vinorelbine-based chemotherapy in patients with advanced
or metastatic Muc1-positive non-small-cell lung cancer (stage IIIB
or IV). The primary endpoint was defined as tumor response rate of
at least 11 responses out of the first 33 evaluable patients. The
following responses were observed in the 35 patients evaluable to
date: -- 13 patients have responded to the treatment according to
the RECIST criteria (partial responses validated in central
review); and -- 11 patients had their disease stabilized for more
than 12 weeks. Together, these results indicate that 24 out of 35
patients (68%) have benefited from the combination of MVA-Muc1-IL2
vaccination with chemotherapy. Good tolerance and safety of
MVA-Muc1-IL2 were confirmed, injection site reaction being the most
frequent side effect. The median time to progression (TTP) as of
today exceeds six months while the median overall survival exceeds
twelve months. More than half of the patients are still alive and
some remain on treatment. The data on response rate, TTP and
overall survival compares favourably with the results usually
obtained with the chemotherapy alone. The results obtained with the
MVA-Muc1-IL2 vaccine are moreover strengthened by the fact that the
Muc1 positivity is in itself a recognized factor of poor prognosis.
Based on these promising results, Transgene expects to start in the
last quarter of 2005 a randomized controlled Phase IIb clinical
trial in combination with standard chemotherapies. MVA-HPV-IL2
therapeutic vaccine: on-going phase II clinical trial against human
papilloma virus infection The current trial is being conducted 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 conducted in the same indication, this
current 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. 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. Only those
still presenting with a CIN2/3 or an HPV infection at the end of
the 6- month period will undergo a surgery (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. Ad-IFNgamma immunotherapy product:
accelerated development in cutaneous lymphoma Ad-IFNgamma is
currently in Phase I/II clinical trial in primary cutaneous T-cell
lymphoma (CTCL). Interim results from 16 evaluable patients out of
26 patients enrolled to date show a 56% global response rate with
six complete and three partial responses. The development strategy
of this product consists in a pivotal Phase II/II controlled trial
to begin in the first quarter of 2006, leading to a possible
marketing authorization in 2009. Discussions are on-going with the
FDA and EMEA accordingly. Transgene has applied for a Special
Protocol Assistance at the EMEA following the European orphan drug
designation of Ad-IFNgamma. In parallel, the company intends also
to obtain orphan drug designation in the United States. MVA-HCV
therapeutic vaccine: a new candidate in infectious disease 170
million persons worldwide are infected by the hepatitis C virus.
The MVA-HCV candidate vaccine, currently in pre-clinical stage,
uses Transgene' s MVA technology and expresses non-structural HCV
proteins. A Phase I/II clinical trial in naive or non-responding
patients is in preparation and is expected to be launched beginning
of 2006. Analysts and Press Presentation The presentation will be
available at http://www.transgene.fr/ under News / Management
presentations at 12 am, Central European Time (6 am US Eastern
time). Conference Call Transgene will conduct a conference call
today, February 23, 2005, at 17:00 Central European Time (11 am US
Eastern time). To participate in the conference call, please call
one of the following numbers within 10 minutes prior to
commencement: +1 718 354 1158 for the U.S. 33 (0) 1 55 17 41 79 for
France 44 (0) 20 7784 1014 for other countries Transgene, based in
Strasbourg, France, is a biopharmaceutical company dedicated to the
discovery and development of therapeutic vaccines and immunotherapy
products for the treatment of cancer and infectious diseases.
Transgene has a broad portfolio of products in clinical
development. This press release contains forward-looking
statements, including statements regarding objectives for cash
expenditures and the potential efficacy, safety and medical
applications of Transgene's product candidates. Statements that are
not historical facts are based on Transgene's current beliefs,
estimates and assumptions, including Transgene's expectations
related to on-going costs and progress in research, development and
clinical and pre- clinical studies. All of Transgene's potential
products are in research, preclinical development or early stage
clinical trials, and, as is the case with all biopharmaceutical
products under development, results from future studies with more
data may show less favorable outcomes. Current results are
preliminary and based upon a small number of patients. It is
uncertain whether any of the products which Transgene is developing
will ever demonstrate adequate therapeutic efficacy or achieve
regulatory approval or commercial use. Important factors which may
affect Transgene's ability to meet its objectives for cash
expenditures or to develop commercially successful products include
the following: Transgene's product candidates may not demonstrate
therapeutic efficacy after initial promising results, Transgene may
not have sufficient resources to complete on-going clinical trials
and continue its planned research and development activities,
Transgene may incur unexpected costs to carry out clinical studies
or due to product liability or intellectual property litigation,
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: Philippe Poncet, C.F.O. and Investors Relations of
Transgene, +33-3-88-27-91-01; or Michael Long of Cohn & Wolfe,
+1-415-365-8523; or Tiphaine Hecketsweiler of Image 7,
+33-1-53-70-74-70 Web site: http://www.transgene.fr/
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