Biovest Conducts End of Phase III Review with FDA of BiovaxID™ as Consolidation Therapy in Non-Hodgkin’s Lymphoma
August 14 2012 - 07:15AM
Business Wire
Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today announced that it conducted a formal clinical guidance
meeting with the U.S. FDA to determine the most expeditious U.S.
registration pathway for BiovaxID™, its personalized cancer vaccine
for the consolidation treatment of follicular non-Hodgkin’s
lymphoma. During the FDA meeting, Biovest reviewed the unmet need
in the U.S. where an estimated 50% of follicular lymphoma patients
achieving first remission do not receive any treatment even though
their cancer is at near-universal risk of relapse. A primary
contributing factor to this urgent medical need for additional
consolidation agents is the immunosuppressive nature of all
approved consolidation agents, which target the same antigen, CD20,
used as part of induction therapy. This includes rituximab which
when used as a consolidation agent (rituximab maintenance) is
generally administered on a bi-monthly dosing schedule over several
years resulting in immunosuppression that is significantly
prolonged as compared to the use of rituximab as an agent in first
line chemo induction therapy or following disease progression. At
the meeting, the FDA required that Biovest conduct a second Phase
III clinical trial to confirm the clinical data generated in the
Phase III trial BV301 and complete the Company’s BiovaxID
development program to support the filing of a Biologics License
Application (BLA). Further, FDA offered to work out with Biovest a
registration trial design for such a confirmatory Phase III study.
The Company intends to accept this FDA offer to meet within the
next several months to advance the clinical development of BiovaxID
to discuss a trial protocol that can most expeditiously generate
registration data using agreed upon endpoints.
In the upcoming meeting with the FDA regarding the design of the
confirmatory registration study, Biovest anticipates exploring the
use of a specific subtype of the idiotype biomarker found in a
retrospective analysis of the first Phase III clinical trial,
BV301. In Biovest’s analysis of the first Phase III trial, the
Company identified the IgM subtype showing an 84% improvement in
duration of first complete remission in patients with this
biomarker who received vaccine compared to matched IgM isotype
control vaccinated subjects (median of 52.9 months in vaccinated
patients vs 28.7 in matched controls; adj. p=0.001).
Concurrent with FDA’s registration activities, Biovest will
continue to advance seeking marketing approvals for BiovaxID in the
European Union (EU) and Canada with those planned applications
supported by evidence of clinical benefit from the three human
clinical trials conducted to date in collaboration with the U.S.
National Cancer Institute (NCI).
Biovest’s President & CEO, Samuel S. Duffey, stated, “The
FDA has clearly defined the U.S. regulatory pathway to approval,
which Biovest is firmly committed to achieving. I believe the FDA’s
guidance, combined with the regulatory feedback received from
Canada and Europe, will facilitate the process that is underway
both in the U.S. and around the world to allow Biovest to seek
potential strategic partnering and licensing relationships.
Importantly, Biovest remains committed to advancing the ongoing
regulatory process seeking marketing approvals in Europe and Canada
in advance of the U.S. to achieve our mission to make BiovaxID the
first cancer vaccine available for lymphoma patients.”
In other regulatory news, the Company reported that it will
conduct an upcoming pre-submission meeting with the European
Medicines Agency (EMA) in London, advancing plans to submit its
Marketing Authorization Application (MAA) seeking EU marketing
approval. Biovest recently reported that the EMA has notified the
Company regarding the official designation of the Rapporteur and
Co-Rapporteur for its planned MAA.
The Rapporteur and Co-Rapporteur are members of the EMA’s
Committee for Medicinal Products for Human Use (CHMP). They are
supported by a team of assessors from their National Authority. The
Rapporteur and Co-Rapporteur have been assigned with the primary
responsibility of preparing and delivering an approvability
evaluation report under the EMA’s Centralized Procedure. Under this
procedure, a registration of BiovaxID throughout all EU-member
countries can be obtained simultaneously via a single application.
Upon approval, BiovaxID would be the first cancer vaccine available
in Europe for lymphoma patients.
The EMA has granted Orphan Medicinal Product designation to
BiovaxID for the treatment of follicular lymphoma and mantle cell
lymphoma, which are B-cell subtypes of non-Hodgkin’s lymphoma.
Orphan Drug status in Europe provides Biovest a 10-year period of
market exclusivity for BiovaxID upon approval for each indication
in the EU, thereby offering competitive protection from similar
drugs of the same class.
About Biovest International,
Inc.
Biovest International, Inc. develops active immunotherapies
(cancer vaccines) which treat and diminish the aggressiveness of
B-cell non-Hodgkin’s lymphoma, a cancer of the immune system. The
Company’s lead personalized cancer vaccine product candidate,
BiovaxID™, has been evaluated in three clinical trials conducted in
collaboration with the U.S. National Cancer Institute (NCI)
demonstrating that BiovaxID increases the duration of cancer
remission following chemotherapy and induces immune responses which
correlate highly with long-term survival. Biovest is currently in
the process of pursuing European and Canadian marketing approvals
for BiovaxID.
Headquartered in Tampa, Florida with its bio-manufacturing
facility based in Minneapolis, Minnesota, Biovest is
publicly-traded on the OTCQB™ Market with the stock-ticker symbol
“BVTI”, and is a majority-owned subsidiary of Accentia
Biopharmaceuticals, Inc. (OTCQB: “ABPI”).
For further information, please visit:
http://www.biovest.com
Forward-Looking
Statements:
Statements in this press release that are not strictly
historical in nature constitute "forward-looking statements.”
Such statements include, but are not limited to, statements
about Biovest and its product candidate, BiovaxID™ and any other
statements relating to products, product candidates, product
development programs, the FDA, the EMA, Health Canada or clinical
study process including the commencement, process, or completion of
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without limitation), statements regarding the timing of anticipated
filing of a Marketing Authorization Application for BiovaxID with
the EMA or a New Drug Submission for BiovaxID with Health Canada,
pre-filing meetings with the FDA or other jurisdictions and/or
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inherent risks of delay in compilation and finalization of all
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These factors include, but are not limited to, risks and
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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
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