Positive, Clinically Significant Phase III Results for Personalized Anti-Cancer Vaccine, BiovaxID, Presented at ASCO Plenary Session

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Sun May 31, 2009 10:30am EDT

* First lymphoma vaccine to demonstrate disease-free survival benefit
* Compassionate-use program to soon launch in Europe

TAMPA, Fla.--(Business Wire)--
Biovest International, Inc. (Other OTC: BVTI), a majority-owned subsidiary of
Accentia Biopharmaceuticals, Inc. (Other OTC: ABPIQ) today announced that an
eight year pivotal, randomized, multi-center, double-blind, controlled Phase III
clinical study has shown that BiovaxID (personalized therapeutic anti-cancer
vaccine) significantly prolonged disease-free survival in follicular
non-Hodgkin`s lymphoma. The study, which is being featured at today`s American
Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, 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 ever
vaccine targeting lymphoma to demonstrate such a disease-free survival benefit. 

BiovaxID is individually manufactured from a tissue biopsy obtained from a
patient`s own tumor, and selectively targets only the cancerous B-cells, while
sparing healthy cells. BiovaxID is highly specific in its anti-lymphoma attack
because the vaccine "trains" the body`s own immune system to recognize as
foreign the unique protein (idiotype) expressed only on the cancerous B-cells,
thus stimulating and recruiting the patient`s own immune system to destroy the
cancer cells and potentially prevent recurrence. In contrast, other existing
chemotherapeutic and monoclonal antibody therapies destroy most of the healthy
B-cells in addition to the cancerous cells, and may result in serious adverse
side-effects. Because the BiovaxID vaccine is comprised of the patient`s own
cells (autologous), the therapy has been demonstrated to be safe and
well-tolerated. 

The final vaccine is administered as a subcutaneous injection along with
granulocyte-macrophage colony-stimulating factor (GM-CSF) and keyhole limpet
hemocyanin (KLH), which together enhances the potency of the immune response
induced by BiovaxID. A previous Phase II study demonstrated that patients
receiving the BiovaxID vaccine developed a highly-specific immune response
against tumor cells, with 95 percent of patients showing significant T-cell
activity against their lymphoma and 75 percent of patients showing a humoral
immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent
of patients remained in continuous first complete remission with a median
disease-free survival of 8 years. 

"With this vaccine, we`ve now moved into an era where we can safely use a
patient`s immune system to effectively fight follicular lymphoma and enhance the
response to conventional chemotherapy," said Stephen J. Schuster, M.D.,
Associate Professor at the University of Pennsylvania School of Medicine and the
study`s lead author. "Because this vaccine uniquely recruits the patient`s
immune system to seek and destroy only tumor B-cells, this approach may be
applicable to the treatment of other B-cell lymphomas." 

The completed Phase III study achieved its primary endpoint of prolonging
disease-free survival in patients who were vaccinated with at least one
injection of BiovaxID as compared to patients who received control. In the
study, 177 patients with follicular lymphoma who had achieved a complete
response to PACE (prednisone, doxorubicin, cyclophosphamide and etoposide)
chemotherapy were randomized to the BiovaxID vaccine (Id-KLH/GM-CSF) or to the
control study arm (KLH/GM-CSF). As prospectively identified, investigators
analyzed the cohort of 117 randomized patients who, as required by the study
protocol, maintained a complete response to chemotherapy for at least six months
and who received active (N=76) or control (N=41) vaccine. After a median
follow-up of 4.71 years (56.6 months, range: 12.6 - 89.3 months), the median
disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6
months in the control arm, which is a clinically and statistically significant
difference (p=0.045). 

BiovaxID demonstrated a favorable safety profile and was very well-tolerated by
patients. Further studies are planned to examine the role of BiovaxID in
patients with other B-cell lymphomas such as mantle cell lymphoma, chronic
lymphocytic leukemia and multiple myeloma. In addition, new lymphoma studies
will evaluate the addition of BiovaxID booster maintenance therapy, which is
expected to even further improve survival benefits by maximizing the chance of
continuously maintaining complete remissions. 

"BiovaxID is a 100% personalized medicine with each vaccine unique to each
patient," stated Biovest`s Chairman and CEO, Francis E. O`Donnell, Jr., M.D.
"Despite the failures of other lymphoma vaccines and the skepticism in general
towards patient-specific cancer immunotherapies, our unprecedented results
presented today are a tribute to the more than 37 years of dedicated vision and
labor by researchers dating back to the first mouse studies using this approach
in the early 1970s. We congratulate and thank all that have been involved at
every level in developing this ultimate targeted therapy, with special
recognition to the National Cancer Institute, who with our Biovest team,
advanced BiovaxID in human clinical trials. And we also offer our profound
thanks to the investigators, and more importantly to the patients that
participated in our Phase II and Phase III clinical trials, as their courage in
fighting this insidious disease is inspiring. It is only because of their
contribution, and with the support of their family and friends, that such
potential breakthrough new therapies can be evaluated and ultimately made
available to all patients in need." 

In addressing regulatory and commercial plans for BiovaxID, Biovest`s President
and General Counsel, Samuel Duffey, commented, "We have already initiated
discussions with the FDA and EMEA and are preparing for further meetings with
those agencies and other international regulatory authorities in order to share
our significant results and determine the most appropriate approval regulatory
pathways. In addition, we plan to make BiovaxID available throughout most of
Europe on a named-patient basis. This compassionate-use drug access program
allows European physicians to prescribe drugs to qualifying patients before
approvals are granted, assuming the protocols for each participating country are
followed." 

Biovest also reported that the Company expects to publish the final
comprehensive results in a peer-reviewed scientific publication later this year.


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. Unlike other failed cancer vaccine
therapies that attempted to target lymphoma, 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 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.
Douglas Calder, Director of Investor Relations & Public Relations
813-864-2554, ext. 258
Email: dwcalder@biovest.com

Copyright Business Wire 2009

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