Bavarian Nordic's CV-301 Cancer Immunotherapy Candidate Shows Promise in Colorectal Cancer
(Thomson Reuters ONE) -
KVISTGAARD, Denmark, May 29, 2013 - Bavarian Nordic A/S (OMX: BAVA) announced
today that promising data from a Phase 2 trial of its CV-301 cancer
immunotherapy candidate in patients with resected metastatic colorectal cancer
were recently published in the Annals of Surgery. In a study conducted at Duke
University, 74 patients who were disease free after surgical resection of
metastatic colon cancer received chemotherapy followed by immunotherapy with
CV-301 (formerly designated as PANVAC-VF) either as CV-301 modified dendritic
cells or in combination with GM-CSF. Compared to a group of contemporary control
patients who were matched for key clinical features and had similar surgery and
chemotherapy, the overall survival of the CV-301 treated patients was
significantly longer (p < 0.0001). Treatment with CV-301 was well tolerated,
with injection site reactions, fever, fatigue and muscle soreness as the most
common side effects.
Michael Morse, MD, an oncologist with the Duke University Medical Center and
lead author on the study, said, "With few treatment options available for
patients with advanced colon cancer following complete surgical resection of
metastases, there is a clear unmet medical need for better treatments. We
believe that the encouraging data from this Phase 2 study support a late stage
pivotal clinical trial of CV-301 in this patient population."
The paper titled: "A Randomized Phase II Study of Immunization With Dendritic
Cells Modified With Poxvectors Encoding CEA and MUC1 Compared With the Same
Poxvectors Plus GM-CSF for Resected Metastatic Colorectal Cancer" can be found
on the Annals of Surgery website:
http://journals.lww.com/annalsofsurgery/Abstract/publishahead/A_Randomized_Phase
_II_Study_of_Immunization_With.98439.aspx
Bavarian Nordic has expanded its license with the National Cancer Institute
(NCI) for CV-301 to include colon cancer. The original collaboration agreement
was executed in 2011, and involved multiple cancers including breast, lung,
ovarian and other cancers. Colorectal cancer is the most frequently diagnosed
cancer and second leading cause of cancer death in developed countries,
according to the American Cancer Society.
"We are excited about exploring the potential of our cancer immunotherapy
platform in colorectal cancer," said James Breitmeyer, EVP of Bavarian Nordic
and President of the Cancer Vaccine Division. "We are optimistic that CV-301
offers patients with colon cancer the same promise of extended survival with a
favorable side effect profile that our other product candidate, PROSTVAC® offers
patients with advanced prostate cancer. This provides an excellent opportunity
to broaden our cancer immunotherapy clinical pipeline with yet another late-
stage product candidate. We now look forward to assessing the complete CV-301
portfolio and expect to present the future development strategy later this
year."
This announcement does not affect the company's expectations for the financial
results for 2013.
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About CV-301
CV-301 (CEA-MUC-1-TRICOM) is an off-the-shelf immunotherapy product candidate
for the treatment of multiple cancers. It originates from the same poxvirus
technology platform as PROSTVAC®.
Both PROSTVAC® and CV-301 are prime-boost vaccines sequentially combining two
different poxviruses (vaccinia and fowlpox). Collectively, these two product
candidates, along with earlier generations of these vaccines, have been the
subject of over 30 clinical trials with more than 1,100 patients actively
treated for prostate, breast, lung, colorectal, gastric, pancreatic, ovarian and
other cancers. These extensive clinical studies suggest that the product
candidates are well-tolerated with the ability to induce specific immune
responses directed against the relevant tumor-associated antigens.
While PROSTVAC® incorporates a single antigen over-expressed in prostate cancer
(PSA), CV-301 incorporates two antigens (CEA and MUC-1) that are over-expressed
in other major cancers, including breast, colon and other cancers, which makes
CV-301 potentially applicable in various cancers.
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 PROSTVAC®, a therapeutic vaccine candidate for
advanced prostate cancer that is the subject of an ongoing pivotal Phase 3
clinical trial and is being developed under a collaboration agreement with the
National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has
been tested in nearly 600 patients. In infectious diseases, the company's lead
program is IMVAMUNE®, 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. IMVAMUNE® is currently in
clinical Phase 3 development and marketing authorization applications have been
filed in EU and Canada. For more information, visit www.bavarian-nordic.com.
Forward-looking statements
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. We undertake no obligation to
publicly update or revise forward-looking statements to reflect subsequent
events or circumstances after the date made, except as required by law.
201313uk:
http://hugin.info/100065/R/1705386/564138.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1705386]
Unternehmensinformation / Kurzprofil:
Bereitgestellt von Benutzer: hugin
" alt="Maya Gold & Silver Inc.: Underground drilling to start at ZgounderDatum: 29.05.2013 - 07:45 Uhr
Sprache: Deutsch
News-ID 264131
Anzahl Zeichen: 7216
contact information:
Town:
Kvistgård
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 240 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Bavarian Nordic's CV-301 Cancer Immunotherapy Candidate Shows Promise in Colorectal Cancer"
steht unter der journalistisch-redaktionellen Verantwortung von
Bavarian Nordic A/S (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
