STRASBOURG, France, March 14 /PRNewswire-FirstCall/ -- Transgene S.A. 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, Switzerland.
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: http://www.clinicaltrials.gov/ct/show/NCT00394693?order=1.
“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.
CR PR Total Total Patient responses evaluable response rate patients 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: cutaneous lymphoma
- TG 1042 was well tolerated up to the highest dose level (3.1011 vp);
- efficient gene transfer of the IFNγ gene was assessed by RT-PCR.
About TG 1042:
TG 1042 is an adenoviral vector containing the human interferon gamma gene.
About Transgene:
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 www.transgene.fr.
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.
Transgene S.A.
CONTACT: 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, +33-1-53-70-74-93
