Just a heads up fellas, Take a look at BVTI

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Rx Senior
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Oct 14, 2004
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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.
 

Stock Investing Guru
Joined
Aug 18, 2009
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Looks interesting, just found this:


FDA Grants Orphan Drug Status for Personalized Lymphoma Vaccine
Biovest International, Inc. (Other OTC: BVTI) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized lymphoma vaccine. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market

With FDA Orphan Drug Status, Biovest has a seven-year period of market exclusivity for BiovaxID upon approval, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduced filing fees for marketing applications. Based on statistically significant Phase III study data demonstrating an extended disease-free survival benefit, Biovest expects to file a Biologic License Application (BLA) with the FDA by approximately mid-year in order to seek U.S. approval of BiovaxID. The Company also expects to file regulatory applications seeking approvals in Europe and Canada

In other news, Biovest announced that the Company will present at the Biotechnology Showcase to be held in San Francisco next week, running concurrent with the JP Morgan 28th Annual Healthcare Conference

Event: Biotechnology Showcase™ 2010 Place: Marines’ Memorial Club & Hotel, San Francisco Biovest Presentation Day/Time: Wednesday, January 13th at 9:00 a.m. (PST) Conference Website: www.ebdgroup.com/bts/ If qualified investors or corporate partnering candidates are interested in scheduling a meeting with Biovest in San Francisco, please contact Douglas Calder at 813-864-2558 or dwcalder@biovest.com

According to Biovest’s President, Mr. Samuel S. Duffey, the Biotechnology Showcase kicks off the year with an opportunity to update institutional investors, bankers and analysts as the Company prepares to emerge from reorganization. “We expect to make announcements in the near future that will demonstrate that we have taken full advantage of the reorganization process in restructuring debt and contractual obligations. We anticipate emerging from reorganization in the first part of 2010 with our current shareholder base successfully preserved and with a greatly improved balance sheet, which will enable management to focus on executing our business and drug development plans,” stated, Mr. Duffey
 

Stock Investing Guru
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Aug 18, 2009
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Yes, the future looks very promising for this company


Chart says there could be a good buying opportunity around .45/.50. I might grab 1k just as a speculative pharma play if it hits this price and holds.

ABPIQ owns 80% of BVTI. Still very iffy at this time.


You might also want to check out BNVI, that's one I really like and has a lot of potential. Both speculative pharma plays. Keep the thread updated if you catch any other news.
 

Rx Senior
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Up to $1.18 yesterday

Up to $1.30 today, another 10%.

Man this is fun. :103631605
 
Joined
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Nice one Injun. Closed at a cool 2.00.

Wish you reminded us around .75/.90. I woulda taken a shot looking at that chart.

Good for you.
 

Rx Senior
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A lot of profit taking today, from $2.00 all the way to $1.47.

Looks like reorganization meeting got postponed until March 24th. I'm not worried though, I'm in this one for the long haul.
 

Rx Senior
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All I know is there was an extension for the reorganization announcement with the creditors until the 24th. I am holding as the drug that BVTI is working to get approved has humungous potential.
 

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Biovest Announces Upcoming Conference Calendar to Present on Personalized Cancer Vaccine Targeting B-cell Lymphomas




By: Business Wire | 17 Mar 2010 | 12:19 PM ET<SCRIPT language=javascript> function UpdateTimeStamp(pdt) ** var n = document.getElementById("udtD"); if(pdt != '' && n && window.DateTime) ** var dt = new DateTime(); pdt = dt.T2D(pdt); if(dt.GetTZ(pdt)) {n.innerHTML = dt.D2S(pdt,((''.toLowerCase()=='false')?false:true));} } } UpdateTimeStamp('634044395400000000');</SCRIPT>
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<SCRIPT type=text/javascript>setDefault('cnbc_textbody');</SCRIPT>TAMPA, Fla. & MINNEAPOLIS, Mar 17, 2010 (BUSINESS WIRE) -- Biovest International, Inc. (Other OTC:BVTI) today announced that the company is confirmed to present its personalized cancer vaccine, BiovaxID(R), at the following upcoming conferences: -- World Vaccine Congress 2010, April 19-22, Washington D.C.
-- BIO International Convention, May 3-6, Chicago -- Active Immunotherapeutics Forum 2010, June 21-23, Barcelona, Spain At these events, Biovest plans to review positive Phase II and Phase III data for BiovaxID and discuss the potential market opportunity including regulatory and manufacturing strategies. The company will make further announcements related to the specifics for each presentation prior to each conference.
In addition, Biovest will be attending the American Society of Oncology's (ASCO) Annual Meeting, June 4-8 in Chicago, intending to meet with corporate partnering candidates, key opinion leaders treating lymphomas and patient advocacy groups.
Biovest's President, Mr. Samuel S. Duffey, stated, "As Biovest and its parent, Accentia Biopharmaceuticals, Inc., prepare to exit from reorganization, it is a priority for us to attend and present at key industry and investor events to communicate the vital role that we envision for BiovaxID in potentially enhancing existing regimens for the treatment of indolent follicular non-Hodgkin's lymphoma and other B-cell blood cancers." About Biovest International, Inc.
Biovest International, Inc. is an emerging leader in the field of personalized immunotherapies targeting life-threatening cancers of the blood system.
Developed in collaboration with the National Cancer Institute, BiovaxID(R) is a patient-specific, anti-lymphoma cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in patients suffering from indolent follicular non-Hodgkin's lymphoma. BiovaxID has been granted Orphan Drug Designation by both the U.S. FDA and the European EMEA.
Biovest has also developed and markets a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID(TM) which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the Over-the-Counter (OTC) market with the stock-ticker symbol "BVTI", and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ).
 

Rx Senior
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Yes Raftis, very good news here. If anyone missed the boat I think now would be a good time to get in at 1.25. Don't see it going anywhere but up from here.
 

New member
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Gentlemen

What are your expectations for BVTI share price?

In my dreams, I keep seeing its price around 20 dollars…
Am I too optimistic?
 

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