Just take a look at this guys.
http://www.accentia.net/media/pr/biovestpr053109.html
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.
http://www.accentia.net/media/pr/biovestpr053109.html
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.
