(Public, OTC:BVTI)

Today, on 9/22/09, StocksHaven Investments had the opportunity of speaking to the Investor Relations representative at Biovest International Inc., Douglas W. Calder regarding the recent profile we conducted. A few minor erroneous details were present, and thus we are issuing a company verified update to clarify these issues.

The first problem at hand was that we mentioned it would be a new drug application, however, it is in fact a biologic license application or, for short BLA. So what is a BLA? A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. Essentially, it is a formal application analogous to a New Drug Application, but for biotechnology-derived pharmaceuticals (for example, complex, large molecules). In other words, BLA is equivalent in some respects to an NDA, when it comes to therapeutics.

Moreover, they are in fact expecting to have a face-to-face meeting with the FDA with regards to BiovaxID sometime in Q1 of 2010, afterwhich depending on the outcome, a BLA submission could follow shortly thereafter. Currently, Biovest is preparing an informational package for the FDA in order to share data on BiovaxID, and a number of other items, such as the manufacturing facility in Miniapolis Minnesota, analysis ongoing with the clinical studies related to immune response, mechanisms of action involving b-cells, t-cells, or perhaps combination of both. Douglas went on to state that, data points the FDA wants to see include the possibility of other predictors that can indicate a more likely outcome of success for the patient. During the meeting, Biovest will also discuss the possibilities of an accelerated approval process for BiovaxID.

Communication with the FDA is ongoing, and Biovest is paying close attention to the draft guidance issued for companies seeking approval with cancer vaccines which are unique to patients, and as well the section for granting of accelerated approval process.

On an ending note, it is important to keep into consideration that the company is under Chapter 11, thus there always exists the unlikely scenario that the current common shares may be cancelled.

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Disclosure: Short term position in BVTI

By reading StocksHaven Investments company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

StocksHaven Investments is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.

(Public, OTC:BVTI)

As individuals in our respective societies, we all abide by a certain moral standing. However, regardless of your lifestyle, you will adhere to the notion that there is no greater feeling in the world than knowing you are helping fund a company which could potentially save millions of lives, while at the same time fulfilling your needs through growing your pockets as well. So without further ado, let’s all welcome Biovest International, Inc. (OTC:BVTI) as StocksHaven Investment’s newest company profile. Recently the company has stricken interest from the investment community through its product, BiovaxID, which has seen very positive Phase III results presented at Asco Plenary Session. BiovaxID is truly revolutionary, the cancer vaccine evokes the power of each patient’s immune system and primes it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. Before beginning the analysis, lets also keep in mind that with the phase III were presented nearly four months ago on 05/31/09, meaning an BLA announcement could come at anytime. Biovest’s President, Samuel Duffey states, ““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.”

About Biovest International Inc.

Biovest International, Inc. (Biovest) is a biotechnology company focusing primarily on the development of BiovaxID, a patient-specific, anti-cancer vaccine focusing on the treatment of follicular non-Hodgkins lymphoma, or follicular NHL. BiovaxID is a customized anti-cancer vaccine that is derived from a patient’s own cancer cells and is designed to utilize the power of the patient’s immune system to recognize and destroy cancerous lymphoma cells, while sparing normal cells. The Company produces this vaccine by extracting some of the patient’s tumor cells and then replicating and purifying the antigen that is present only on the surface of the patient’s own tumor cells. Biovest is conducting a pivotal Phase 3 clinical trial for BiovaxID in patients with the indolent, or low-grade, form of B-cell follicular NHL.

In addition, Biovest is in Chapter 11 under bankruptcy protection, and the company is currently navigating the reorganization process. They are also not compliant with SEC financial reporting rules at this time.

Products

BiovaxID Cancer Vaccine

The Biovest cancer immunotherapy stems from work begun in 1986 on development of a patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine evokes the power of each patient’s immune system and primes it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. In the vaccine’s cancer target, B-cell lymphoma, the process is made possible by the presence of a hallmark surface antigen of the cancer cells that is not present in non-cancerous tissue. By priming the immune system with this antigen in the form of an autologous vaccine, the vaccine induces a powerful immune response against the cancerous cells that in many cases results in pronounced, complete cancer clearance. Because each dose of Biovest’s vaccine is derived from individual patient’s cancerous cells, the vaccine is a true targeted, customized therapy. The vaccine’s powerful anti-tumor effect vastly exceeds that of non-targeted traditional therapy, as it arises from the immune system’s defense cells’ innate ability to selectively target foreign antigens. Most importantly, the immune response triggered by the vaccine against the cancerous tissue is a natural disease-fighting mechanism and has almost none of the side-effects associated with the broad-spectrum chemotherapy and radiation used to traditionally treat this type of lymphoma.

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.

Futhermore, as the leading manufacturer of hollow fiber technology and with over 2 decades of cell culture experience, Biovest has pioneered a unique platform to commercialize patient-specific biologics. What makes this vaccine truly unique is the fact that made from each patient, for each patient using the AutovaxID.

BiovaxID utilzes a patient specific process to create tailor-made therapeutic cancer vaccines

About Non-Hodgkin’s Lymphoma & Target Market

The European non-Hodgkin’s lymphoma therapeutics market is estimated to reach $7.2 billion in 2013 from the current size of $2.2 billion.

There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US with a comparable number in Europe. Despite the use of aggressive chemotherapy and recent advances in therapy such as monoclonal antibodies (Rituxan, TM), the disease is almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent but ultimately fatal clinical course. The median relapse time for FL patients is three years, with 90% of patients dying of a tumor-related mortality within 7 years of the date of diagnosis. The clinical course is usually characterized by a series of remissions and relapses. Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte transplantation, and monoclonal antibodies. However, following initial response to treatment, the cancer invariably returns and the majority of patients relapse with resistance to all available therapy. Related B-cell derived neoplasms include multiple myeloma (approx. 15,000 cases/year in the US and chronic lymphocytic leukemia (approx. 10,000 cases/year in the US).

Positive Critical Phase III Trials

Biovest International, Inc.  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 was featured at the 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.

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.

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).

FDA Update

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 (Q4 of 2009).

Mentor Capital Cancer Immunotherapy Index

The inclusion of BVTI on the Mentor Capital Immunotherapy Index is a tremendous step for this company on several fronts.  First of all, it was named one of the top 10 under $10 companies that is involved in cancer treatments which are considered ground-breaking.  Among the companies on that list include DNDN, Celldex, and Oncothyreon, to name a few.  All of these companies have either reached great end points in their respective critical phase trials, or have great potential.  BVTI is one that has yet to reach its potential.  To project the estimated price per share, one needs to look no further than the other companies on the list that have reached their potential.  DNDN $23 price per share, Celldex $6 price per share, Onco $5 price per share, are the three that have so far blossomed the most.  With a similar, yet more advanced treatment study having been completed and implemented in Europe, one would think BVTI can do a similar run-up, once they file an BLA with the FDA.  The second major point is the funding that is available to them through this arrangement with Mentor Capital.  Perhaps the sole reason for the company’s low price per share has been the fact that their parent company is in chapter 11. Finally, and possible the most surprising and most exciting part is the market cap of 50 million dollars, which may not stand for much longer. Thirteen years of testing and research went into this treatment (phase III lasted 8 years).  Does anyone else see DNDN before them?  The use of this treatment in Europe on a named patient basis is getting noticed and provides even more results, not to mention gives the company a face.

Technical Chart Analysis ( click image to enlarge )

These past six months have seen impressive gains in both volume and price for BVTI, as it appears to be gaining momentum for another healthy increase in share price.  There are strong bullish signals such as the daily 100 SMA (Orange line) currently running above the daily 200 SMA (Yellow line) and both moving averages are on the rise. Also, the year-to-date price action has established an upward trending price channel shown in Blue on the chart.  The channel’s definition was actually expanded back in June when the price gained over 1200% in just one month and the volume increased over 10,000%.  This movement revealed the current channels the price has been moving within, but also indicates the overall channel is actually much taller.  The top of the conservative price channel is currently at $1.03.  Today the price bounced off the bottom trend-line, closed right at the ¼ trend-line of the Blue channel, and showed there is pressure to go higher. Once the price exceeds the mid-line (dashed Blue line) currently around .67 cents, the price should easily find the top trend-line of the price channel. With the current increase in volume this month reaching over 20,000% so far, it’s good to keep in the back of your mind that the last time the price made it to the top of the channel it reached $1.50 and that’s over a 200% gain from today’s close.

Overall Sentiment

Now, we perceive BVTI to be somewhat of an iceberg. It is easy to see the tip, however the true size of it can’t be seen by the naked eye, or average daily investor without conducting some thorough due diligence. Spend a couple of minutes researching and you will notice the 52wk high of $1.50, the fact that it is an extremely successful phase III cancer drug with a billion dollar market potential, and a top 10 under $10 nominee, though one key aspect is missing: the CEO, Francis O’Donnell’s importance. Not many realize he is also the Chairman of  BioDelivery Sciences — Yes, that same company who gained FDA approval for its cancer pain drug patch, Onsolis.

An experienced CEO who is well acquainted with what it takes to attain FDA approval, positive Phase III completed four months ago, being a part of one of the most prestigious cancer biotech indexes worldwide, and a 52wk high of$1.50 — We shouldn’t even have to state how undervalued Biovest International Inc. truly is.

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Disclosure: Short term position in BVTI

By reading StocksHaven Investments company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

StocksHaven Investments is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.