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Transgene Presents Updated Positive Phase II Data of Its
Therapeutic Vaccine MVA-MUC1-IL2 In Prostate Cancer at Annual ASCO Meeting
STRASBOURG, France, May 16 /PRNewswire-FirstCall/ -- Transgene (Nasdaq: TRGNY;
Eurolist Paris: FR0005175080) is pleased to announce that Dr. Robert Dreicer of
the Cleveland Clinic Foundation, presented yesterday in an oral session the
results of a Phase II clinical study with Transgene's therapeutic cancer
vaccine MVA-MUC1-IL2 in prostate cancer at the annual meeting of the American
Society of Clinical Oncology (ASCO) in Orlando, Florida.
In this study, 40 men with rising PSA (Prostate Specific Antigen), who have had
primary local treatment by surgery or radiation, were treated with MVA-MUC1-IL2
alone. In this clinical situation, also known as biochemical failure, a rising
PSA is the sole manifestation of a silently progressing disease. PSA may
therefore be used as a surrogate marker of the disease evolution.
The findings of the study were the following:
(1) In 63% of the patients, MVA-MUC1-IL2 induced a significant increase
in the time the PSA takes to double.
(2) In 30% of the patients, The PSA doubling time (PSA-DT) was more than
twice as long, in comparison with the pre-vaccination status.
These findings indicate that MVA-MUC1-IL2 is biologically active against
prostate cancer. It is expected that this effect on the PSA-DT will translate
into a slowing of the disease progression.
The study was also designed to test two dosing schedules of the vaccination: a
weekly injection for six weeks followed by an injection every three weeks
versus injections every three weeks. While a lengthening of the PSA-DT has been
observed with both dosing schedules, the level of statistical significance was
higher for the weekly schedule (p=0.005) compared to the three-week schedule
(p=0.02). This information will be of importance in determining the best
administration schedule of MVA-MUC1-IL2 in future approaches targeting other
MUC1-expressing cancers.
"The findings from this preliminary study are both interesting and encouraging.
While additional studies will be required to define the ultimate utility of
this vaccine in patients with prostate cancer, it is clearly well tolerated and
accepted by patients," stated Dr. Robert Dreicer.
"These results, together with those of another phase II study with MVA-
MUC1-IL2 in patients with advanced Non Small Cell Lung Cancer to be presented
at ASCO on Tuesday, May 17, 2005, support our decision to move this product
forward in further developments," stated Philippe Archinard, Chief Executive
Officer of Transgene.
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 referring to the
encouraging results of clinical testing of one of Transgene's product
candidates. However, as is the case with all biopharmaceutical products under
development, results from future studies with more data may show less favorable
outcomes, and there is no certainty that they will ever demonstrate adequate
therapeutic efficacy or achieve regulatory approval or commercial use. For a
description of the risks facing the successful development of Transgene's
products, including uncertainty regarding Transgene's ability to obtain
financing for continued operations, see Transgene's Annual Report on Form 20-F
and its other reports on file with the U.S. Securities and Exchange Commission.
DATASOURCE: Transgene
CONTACT: Patrick Squiban, VP, Medical & Regulatory Affairs,
+33-0-3-88-27-91-73, or Tiphaine Hecketsweiler, +33-0-1-53-70-74-70, both of
Transgene
Web site: http://www.transgene.fr/