Bavarian Nordic Announces Presentation of PROSTVAC® Data at the 2011 ASCO Annual Meeting
(Thomson Reuters ONE) -
Kvistgård, Denmark, June 1, 2011 - Bavarian Nordic A/S (OMX: BAVA) today
announced that investigators from the National Cancer Institute are presenting
at the 2011 ASCO Annual Meeting in Chicago data from a study with PROSTVAC®
entitled "Intraprostatic PSA-TRICOM vaccine administration in patients with
locally recurrent prostate cancer".
In this study 21 patients with locally recurrent prostate cancer after primary
radiation therapy were enrolled and received initial vaccination with
subcutaneous injection of PROSTVAC® and booster intraprostatic injection of
PROSTVAC®. The vaccine was well tolerated with only one grade 3 adverse event
(fever). 18 of 21 patients had stable or improved PSA on study. 16 of 21
patients had stable or improved PSA doubling time. A paired t-test of 13
biopsies pre- and post-vaccination showed increases in tumor immunologic
infiltrates. CD3+ cells increased from 12.3 to 21.3/high power field (hpf)
(p=0.0079). CD4+ cells increased from 1.3 to 13.1/hpf (p=0.0002). CD8+ cells
rose from 6.4 to 14/hpf (p=0.0002). Intraprostatic administration of PROSTVAC®
appears safe, feasible and can generate a substantial immune response. Improved
PSA kinetics and intense post-vaccination immune infiltrates were seen in the
majority of patients.
An abstract of the presentation can be found here:
http://abstract.asco.org/AbstView_102_76746.html
This study suggests that PROSTVAC® is active in stages of prostate cancer as
early as locally recurrent disease. Further studies evaluating the efficacy of
PROSTVAC® in this setting are thus promising and warranted.
The DCTD/NCI-sponsored study was conducted under the cooperative research and
development agreement (CRADA) that Bavarian Nordic has with the NCI for further
development of PROSTVAC®.
Anders Hedegaard, President & CEO of Bavarian Nordic said: "While the pivotal
Phase 3 trials with PROSTVAC® that are set to start later this year are designed
to verify the vaccine's potential to improve survival in metastatic disease, we
are delighted to again present convincing data that support the use of PROSTVAC®
in earlier disease settings, suggesting a potential for broader usage of the
vaccine in prostate cancer."
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's clinical pipeline
targets cancer and infectious diseases, and includes seven development
programmes. Two programmes are under preparation for Phase 3: PROSTVAC(®), a
therapeutic vaccine for advanced prostate cancer is being developed under a
collaboration agreement with the National Cancer Institute, and IMVAMUNE(®), a
third-generation smallpox vaccine is being developed under a contract with the
US government.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit www.bavarian-nordic.com
PROSTVAC(®) is a registered trademark in the U.S.
20110601uk:
http://hugin.info/100065/R/1520528/456873.pdf
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Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1520528]
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Datum: 01.06.2011 - 08:40 Uhr
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News-ID 55206
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