STRASBOURG, France, March 14 /CNW/ - Transgene S.A. (Eurolist Paris:
FR0005175080) announces that the first patients have been enrolled in a
two-step Phase II trial with its immunotherapy product candidate TG 1042 to
treat relapsing cutaneous B-cell lymphoma (CBCL), a rare malignancy of the
skin. The patients were enrolled at the University Hospital, Zurich,
In the first stage of this trial, a group of 13 patients with relapsing
CBCL will be enrolled at centers in the U.S., France and Switzerland. Results
from this group of patients should be available by the end of 2007. The
results, if positive, should allow for the continued recruitment of an
additional group of 28 patients in a second confirmatory stage. Transgene will
discuss with the health authorities the acceptability of this two-step Phase
II trial to support an application for marketing authorization for the
treatment of relapsing CBCL. Relapsing CBCL is an orphan disease for which an
optimal medical treatment has yet to be established.
The primary objective of this non-controlled, open label study is to
evaluate the efficacy of a four-month treatment of intra-lesional injections
of 5 x 1010 viral particles (vp) per lesion of TG 1042 in patients with
relapsing CBCL after standard first line treatments. Patients will receive
injections of TG 1042 to induce an anti-tumor immune response. Clinical
endpoints are regression and disappearance of lesions, safety and quality of
life. Further information about the trial is available at the U.S. National
Institute of Health Clinical Trials website:
"We are very pleased to initiate this Phase II clinical trial in CBCL,
which builds on the very good results from our TG 1042 Phase I/II program,"
said Philippe Archinard, Chief Executive Officer of Transgene. "We have strong
hopes that, given the increasing need for efficient treatment modalities in
this orphan indication, positive results in this trial could lead to
regulatory approval in 2009 for a market launch, which would make TG 1042
Transgene's first product to be commercialized."
About Primary Cutaneous Lymphomas:
Primary cutaneous lymphomas (CL) comprise a heterogeneous group of
malignancies arising from malignant clonal proliferation of cutaneous
lymphocytes. CL originate from either T lymphocytes (CTCL) or B lymphocytes
(CBCL). Primary CL represent the second most common extra nodal form of
non-Hodgkin's lymphomas and are characterized by their heterogeneity of
clinical presentations, prognoses and therapeutic options.
Primary CBCL represents about 25% of CL patients. Primary CBCL is
characterized by restriction to the skin, a relatively favourable, but highly
variable prognosis and yet a high incidence of recurrence after first line
treatments. In addition, most CBCLs are indolent diseases presenting a chronic
course sometimes over decades. Therefore there is an increasing need for
efficient therapies to control the disease over a long time period.
Summary of Phase I/II results:
Positive results from the Phase I/II trial were presented at the 2005
American Society of Hematology (ASH) meeting and confirmed at ASCO 2006 in
Atlanta, Georgia (U.S.A.).
This open-label, multicenter, dose-escalation Phase I/II trial enrolled a
total of 39 patients with relapsing primary cutaneous lymphoma (either T-cell
or B-cell lymphoma). While the overall response rate was 53%, all five
evaluable patients with CBCL responded to the TG 1042 treatment (three CR and
two PR). These results suggest that intralesional therapy with TG 1042
represents a non-toxic and effective treatment for CBCL.
Total evaluable response
CR PR responses patients rate
CTCL 7 6 13 29 45%
CBCL 3 2 5 5 100%
Total CL 10 8 18 34 53%
CTCL: cutaneous T-cell lymphoma - CBCL: cutaneous B-cell lymphoma - CL:
- TG 1042 was well tolerated up to the highest dose level (3.1011 vp);
- efficient gene transfer of the IFNI(3) gene was assessed by RT-PCR.
About TG 1042:
TG 1042 is an adenoviral vector containing the human interferon gamma
Transgene is a France-based biopharmaceutical company dedicated to the
development of therapeutic vaccines and immunotherapeutic products in oncology
and infectious diseases. The company has three compounds in Phase II trials
and one compound in Phase I studies. Transgene has bio-manufacturing
production capacities for viral-based vectors and technologies available for
out-licensing. For further information about Transgene, please visit
Cautionary comments regarding forward-looking statements:
This press release contains forward-looking statements referring to the
clinical testing, approval and commercialization of one of Transgene's
therapeutic product candidates. However, clinical testing and product
development depend on a variety of factors, including the timing and success
of patient enrolment and the risk of unanticipated adverse patient reactions.
Results from future studies with more data may show less favorable outcomes
than prior studies, and there is no certainty that product candidates will
ever demonstrate adequate therapeutic efficacy or achieve regulatory approval.
The successful commercialization of a product also requires adequate financial
and marketing support and acceptance by the medical community, none of which
can be assured at this time. Finally, Transgene's currently available
financial resources do not ensure its continued activity beyond the end of
2007, and thus further financing would be required to complete the product
testing and development described above. For further information on the risks
and uncertainties involved in the testing and development of Transgene's
product candidates, see Transgene's Document de reference on file with the
French Autorite des marches financiers.
For further information:
For further information: Press Contacts: Transgene, Philippe Poncet,
+33-3-88-27-91-21, Capital MS&L, Mary Clark, Halina Kukula,
+44-(0)20-7307-5330, Image 7, Estelle Guillot-Tantay, Tiphaine Hecketsweiler,