Bavarian Nordic Presents New Clinical Data on PROSTVACÂ® at the 2013 Genitourinary Cancers Symposium
KVISTGAARD, Denmark - February 13, 2013 - Bavarian Nordic A/S (OMX: BAVA) today
announced that four abstracts on the Company's therapeutic cancer vaccine
candidates for the treatment of prostate cancer, PROSTVACÂ® and MVA-BNÂ® PRO will
be the subject of four clinical presentations at the 2013 Genitourinary Cancers
Symposium on February 14-16, 2013 in Orlando, Florida.
Two posters feature clinical data of PROSTVACÂ® evaluated as monotherapy or in
combination with a radiopharmaceutical. A third poster reviews the safety
profile of poxviral vaccines from 8 different clinical trials of PROSTVACÂ® and
CV-301. The final poster reviews results from the Phase 1 dose escalation trial
of MVA-BNÂ® PRO. The preliminary results from these studies support the further
clinical investigation in patients suffering from advanced prostate cancer.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "We are pleased that
the clinical trial results of our immunotherapy candidates, including PROSTVACÂ®,
are being presented at a major medical conference. These preliminary data
provide insight into the tolerability and unique profile of our poxviral
platform for developing innovative cancer immunotherapies."
The abstracts can be seen in full at Genitourinary Cancers Symposium's website:
Abstract #57: Effect of PSA-TRICOM, a pox-viral vaccine in prostate cancer
(PCa), on tumor growth rates within 80 days after initiation in non-metastatic
Presenter: James L. Gulley, M.D., Ph.D., F.A.C.P.-Laboratory of Tumor Immunology
and Biology, Medical Oncology Branch, National Cancer Institute (NCI)
In this NCI sponsored study, the effect of PSA-TRICOM (PROSTVACÂ®) vaccination
was evaluated in 50 hormone naÃ¯ve patients with non-metastatic prostate cancer
in a multi-center trial (ECOG 9802). Prostate specific antigen (PSA) values were
used to calculate tumor growth rate within the first 100 days of treatment.
The preliminary data from this study suggest that PROSTVACÂ® can alter the tumor
growth rate significantly within 3 months after therapy initiation. The slowing
of tumor growth rate could potentially translate to an improved overall
survival, which will be evaluated in the ongoing global PROSPECT Phase 3 trial
of PROSTVACÂ®, in asymptomatic or minimally symptomatic, metastatic castration-
resistant prostate cancer that is currently enrolling patients.
Abstract # 102: A Phase II randomized clinical trial of Samarium-153 EDTMP (Sm-
153) with or without PSA-TRICOM vaccine in metastatic castration-resistant
prostate cancer (mCRPC) after docetaxel.
Presenter: Christopher Ryan Heery, MD - Laboratory of Tumor Immunology and
Biology, Medical Oncology Branch, National Cancer Institute
This NCI-sponsored Phase 2 multi-center trial was designed to evaluate the
progression-free survival (PFS) in metastatic castration-resistant prostate
cancer patients receiving either Sm-153 alone (Arm A) or in combination with
PROSTVACÂ® (Arm B). Of 44 patients enrolled, 39 were evaluable. At four months,
the PFS for evaluable patients in Arm A was 11.1% (2/18 patients) compared to
23.8% (5/21 patients) in Arm B. Median PFS for patients in Arm A was 1.7 months
compared to 3.7 months in Arm B. (Hazard ratio 0.502, p=0.045)
This final analysis suggests the combination of PROSTVACÂ® and Sm-153 has a
similar toxicity profile to Sm-153 alone. Also, it appears to demonstrate
improvement in PFS with the combination. This may indicate potential synergy
between PROSTVACÂ® and bone-seeking radiopharmaceuticals.
Abstract #85: Safety profile of poxviral vaccines: NCI experience.
Presenter: Joseph W. Kim, MD - Laboratory of Tumor Immunology and Biology,
Medical Oncology Branch, National Cancer Institute
This abstract evaluates data from a total of 1,343 subcutaneous poxviral
injections from 215 patients in 8 NCI-sponsored clinical trials. Each vaccine
consisted of recombinant vaccinia and recombinant fowlpox encoded with 3 human
costimulatory molecules (TRICOM), and prostate specific antigen (PSA) -
PROSTVACÂ®, or carcinoembryonic antigen (CEA) and mucin-1 (MUC-1) which is CV-
No contact transmissions, inadvertent inoculations, or any serious adverse
events related to vaccinia were observed in these eight studies. Grade 2
injection site reactions were reported in 31% (423 poxviral injections). These
preliminary data suggest that poxviral vaccines are well-tolerated at a broad
range of doses, in combination with other treatments, and in various tumor
Abstract #193: Phase I dose escalation trial of MVA-BNÂ® PRO in men with non-
metastatic castration-resistant prostate cancer.
Presenter: David G. McLeod, MD - Walter Reed National Military Medical Center
In this open label Phase 1 dose escalation multi-center trial, MVA-BNÂ® PRO, an
investigational prostate cancer immunotherapy designed to express sequences that
control immunity to prostate specific antigen (PSA) and Prostatic Acid
Phosphatase (PAP), was administered to twenty-four subjects with non-metastatic
castration-resistant prostate cancer. All subjects completed the initial 3
vaccinations (treatment) and 21 subjects received 6 vaccinations (re-treatment).
Seven responders received additional vaccinations during the extended treatment.
MVA-BNÂ® PRO was well-tolerated across all dose regimens and no dose-limiting
toxicities or severe adverse events were reported. The preliminary study results
indicate MVA-BNÂ® PRO may have the ability to induce a tumor-specific immune
response that may play a role in reducing disease progression.
Chairman of the Board
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 pipeline targets cancer
and infectious diseases, and includes ten development programs. In oncology, the
company's lead program is PROSTVACÂ®, a therapeutic vaccine candidate for
advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial
and is being developed under a collaboration agreement with the National Cancer
Institute. In clinical Phase 1 and Phase 2 trials, PROSTVACÂ® has been tested in
nearly 600 patients. In infectious diseases, the company's lead program is
IMVAMUNEÂ®, a non-replicating smallpox vaccine candidate that is being developed
and supplied for emergency use to the U.S. Strategic National Stockpile under a
contract with the U.S. Government. For more information, visit www.bavarian-
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