Biovest and idis Partner to Facilitate Patient Access to Lymphoma
Vaccine
Phase III Study Results to Be Presented at “Best of ASCO” in Paris
Biovest International, Inc. (Other OTC:BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), today
announced that BiovaxID®, Biovest’s personalized therapeutic anti-cancer
vaccine, is available on a named-patient (compassionate-use) basis in
Europe. Following compliance with local regulatory protocols, BiovaxID
will be supplied by idis Limited to European healthcare professionals
for the treatment of follicular non-Hodgkin’s lymphoma and potentially
for other B-cell blood cancers such as chronic lymphocytic leukemia,
mantle cell lymphoma and multiple myeloma. Physicians in non-European
countries may also contact idis to inquire about the potential
availability of BiovaxID, as idis manages named-patient programs in more
than 100 countries.
According to world-renowned hematologist and lymphoma research pioneer,
Professor Volker Diehl, M.D., Ph.D., Professor of Medicine, University
of Cologne, “With the availability of this truly patient-specific
vaccine, I believe hematologists now have a new, safe lymphoma treatment
option capable of enhancing existing chemotherapeutic and monoclonal
antibody treatment options by training the patient’s own immune system
to selectively recognize and attack cancer cells, resulting in
potentially longer lasting remissions. As follicular lymphoma so far is
supposed to be a generally incurable and fatal blood cancer, it is with
great hope and expectations that I welcome such a highly personalized
therapeutic approach in addressing an urgent unmet need.” Prof. Dr.
Diehl founded the German Hodgkin Study Group and is a recipient of the Bundesverdienstkreuz
(Order of Merit of the Federal Republic of Germany), awarded by the
German government for his lifetime achievements in the field of lymphoma
research.
The BiovaxID Phase III study results were recently presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting Plenary
Session, reporting that an eight year pivotal, randomized, multi-center,
double-blind, controlled clinical study demonstrated that BiovaxID
significantly prolonged disease-free survival in follicular
non-Hodgkin’s lymphoma. The study found that patients who received
BiovaxID experienced a median disease-free survival of 44.2 months
compared to 30.6 months for those who received a control vaccine – an
increase of 47 percent. In the study, with a median follow-up of 4.7
years, patients receiving BiovaxID experienced a 38% lower risk of
disease recurrence compared to patients receiving the control vaccine.
BiovaxID is the first vaccine targeting lymphoma ever to demonstrate
such a disease-free survival benefit and because the vaccine is
comprised of the patient’s own cells (autologous), the therapy has been
demonstrated to be safe and well-tolerated.
Later today, the BiovaxID Phase III study results will again be
presented at the “Best of ASCO” event to be held at the Maison de la
Chimie, in Paris, France at 4:15 p.m. local time. The discussants for
the BiovaxID abstract (abstract 33572) will be Jean-Luc Harousseau,
M.D., Head of the Department of Clinical Hematology at the Central
Laboratory of Hematology in Nantes, France and Vice President of the
French Society of Hematology, and Christian Gisselbrecht, M.D., Ph.D.,
of the Institut d'Hématologie, Hôpital Saint-Louis in Paris, France.
Prof. Dr. Diehl also anticipates that the addition of BiovaxID booster
shots could substantially bolster patient results, stating, “The
recently reported Phase III results, while impressive, did not include a
BiovaxID maintenance regimen consisting of periodic booster shots. Such
a maintenance booster regimen may be key in continuing to stimulate a
robust and enduring immune response, thus further improving results, and
perhaps even resulting in durable remissions for some patients.” Biovest
intends to include multiple booster vaccines for potential maintenance
therapy purposes as part of the vaccine delivery for prescriptions
processed under the named-patient program.
As BiovaxID is individually manufactured from a tissue biopsy obtained
from a patient’s own tumor, a patient wishing to participate in the
named-patient program must undergo a lymph node biopsy prior to
receiving chemotherapy/monoclonal antibody therapy. Those cells
collected by biopsy will then undergo a preparation process performed by
Biovest with the resulting vaccine material then preserved until
manufacture of the final vaccine is prescribed by the patient’s
physician through idis. The vaccine is typically administered
approximately 6 months following the end of chemotherapy, and consists
of five BiovaxID vaccinations, subcutaneously injected, over a 6 month
period (months 1,2,3,4 and 6). As an adjuvant therapy, at each
vaccination cycle, patients will also receive four daily injections of
an immune stimulating agent, GM-CSF. At the physician’s option, a
periodic vaccine booster maintenance regimen may also be prescribed.
A named-patient program is a compassionate-use drug supply program under
which physicians are permitted to supply investigational drugs to
qualifying patients. Under a named-patient program, investigational
drugs may be administered to patients who are suffering from a serious
illness prior to the drug being approved by the European Medicines
Evaluation Agency (EMEA). “Named-patient” distribution refers to the
distribution or sale of a product to a specific healthcare professional
for the treatment of an individual patient, assuming compliance with the
local regulatory protocols respective to each participating country. In
Europe, under the named-patient program, the drug is most often
purchased through the national health system.
Contact Information for BiovaxID
Named-Patient Program:
Licensed hematologists can learn more regarding BiovaxID and the
named-patient program by contacting:
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idis Limited (United Kingdom)
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Telephone: +44 (0) 1932 824 123
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Fax: +44 (0) 1932 824 323
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Email: internationalsales@idispharma.com
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About BiovaxID®
BiovaxID is a personalized, patient-specific therapeutic vaccine
designed to stimulate the patient's own immune system to recognize and
destroy cancerous B-cells that may remain in the body or may arise after
the patient has been treated with chemotherapy. Unlike many other
approaches to treating non-Hodgkin’s lymphoma, BiovaxID is designed to
kill only cancerous B-cells, with the initial indication of follicular
Non-Hodgkin's lymphoma. Additionally, it is anticipated that BiovaxID
could be used to treat other types of B-cell cancers, such as mantle
cell lymphoma, chronic lymphocytic leukemia and multiple myeloma.
A Unique Approach to Immunotherapy
Targeting B-Cell Blood Cancers
B-cells (a type of white blood cell or lymphocyte) are a vital part of
the human immune system, as they produce antibodies that seek out and
bind to foreign substances in the body. In lymphoma, as cancerous
B-cells develop and multiply unrestrained, each malignant B-cell
expresses a unique idiotype or biomarker on the cell’s surface, specific
to each patient. Research at Stanford University and the National Cancer
Institute led to the development of BiovaxID as a personalized,
therapeutic vaccine capable of selectively targeting only cancerous
B-cells, while sparing healthy cells. This is achieved by using the
idiotype obtained from a sample of the patient’s tumor by biopsy, and
through proprietary bioengineering techniques in a patented cell line, a
patient-specific vaccine is created that stimulates the immune system by
recruiting a patient’s T-cells (immune cells that kill cancerous cells)
to seek out and destroy only the diseased B-cells. BiovaxID is the only
hybridoma (patient’s lymphoma cells are fused to a heteromyeloma cell
line to produce the tumor specific idiotype protein) anti-cancer vaccine
that consists of a high-fidelity copy of the complete idiotype, believed
to be critical in mounting a full and complete immune response against
the cancer, as well as “training” the immune system to maintain
continuous response if cancerous cells were to return.
About idis Limited
idis is the world leader in the development and implementation of
named-patient programs and has a proven track record of working in
strategic partnership with US-based companies to bring new drugs to
Europe for the first time. idis supports customers in over 100
countries, supplying more than 400 different medicines per month and
responding to more than half a million requests on a named-patient basis
to medical professionals worldwide. For more information on idis please
visit their website at http://www.idispharma.com.
About Biovest International, Inc.
Biovest International, Inc. (Other OTC: BVTI) is a pioneer in the
development of advanced individualized immunotherapies for
life-threatening cancers of the blood system. Biovest is a
majority-owned (75%) subsidiary of Accentia Biopharmaceuticals, Inc.
(Other OTC: ABPIQ) with its remaining shares publicly traded. Biovest
has a foundation in the manufacture of biologics for research and
clinical trials. In addition, Biovest develops, manufactures and markets
patented cell culture systems, including the innovative AutovaxID™,
which is being marketed as an automated vaccine manufacturing instrument
and for production of cell-based materials and therapeutics. Biovest
recently completed a pivotal Phase 3 clinical trial for BiovaxID®, which
is a patient-specific anti-cancer vaccine focusing on the treatment of
follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track
status by the FDA and Orphan Drug status by the EMEA.
For further information, please visit: http://www.biovest.com
Forward-Looking Statements:
Statements in this release that are not strictly historical in nature
constitute "forward-looking statements." Such
statements include, but are not limited to statements about BiovaxID®,
AutovaxID™, events occurring after dates hereof, and any other
statements relating to products, product candidates, product development
programs, the FDA or clinical study process including the commencement,
process, or completion of clinical trials or the regulatory process. Such
statements may include, without limitation, statements with respect to
the Company's plans, objectives, expectations and intentions, and other
statements identified by words such as "may," "could," "would,"
"should," "believes," "expects," "anticipates," "estimates," "intends,"
"plans," or similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties, and other
factors that may cause the actual results of Biovest to be materially
different from historical results or from any results expressed or
implied by such forward-looking statements. These factors
include, but are not limited to, risks and uncertainties related to the
progress, timing, cost, and results of clinical trials and product
development programs; difficulties or delays in obtaining regulatory
approval for product candidates; competition from other pharmaceutical
or biotechnology companies; and the additional risks discussed in
filings with the Securities and Exchange Commission. All
forward-looking statements are qualified in their entirety by this
cautionary statement, and Biovest undertakes no obligation to revise or
update this news release to reflect events or circumstances after the
date hereof. The product names used in this statement are for
identification purposes only. All trademarks and registered trademarks
are the property of their respective owners.
Biovest International, Inc.
Corporate
Contact:
Douglas Calder, Director of Investor Relations
& Public Relations
813-864-2554, ext.258
dwcalder@biovest.com