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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/