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SALE in EUROPE started, partnered with IDIS Pharma. Big step for BVTI moving forward.
Ok got me some...
BVTI: Personalized Anti-Cancer Vaccine, BiovaxID(R), Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis ((((LINK BACK FOR DD))))
Personalized Anti-Cancer Vaccine, BiovaxID(R), Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis Biovest and idis Partner to Facilitate Patient Access to Lymphoma Vaccine
TAMPA, Fla., Jun 28, 2009 (BUSINESS WIRE) -- --Phase III Study Results to Be Presented at "Best of ASCO" in Paris
Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), today announced that BiovaxID(R), Biovest's personalized therapeutic anti-cancer vaccine, is available on a named-patient (compassionate-use) basis in Europe. Following compliance with local regulatory protocols, BiovaxID will be supplied by idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin's lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Physicians in non-European countries may also contact idis to inquire about the potential availability of BiovaxID, as idis manages named-patient programs in more than 100 countries.
According to world-renowned hematologist and lymphoma research pioneer, Professor Volker Diehl, M.D., Ph.D., Professor of Medicine, University of Cologne, "With the availability of this truly patient-specific vaccine, I believe hematologists now have a new, safe lymphoma treatment option capable of enhancing xisting chemotherapeutic and monoclonal antibody treatment options by training the patient's own immune system to selectively recognize and attack cancer cells, resulting in potentially longer lasting remissions. As follicular lymphoma so far is supposed to be a generally incurable and fatal blood cancer, it is with great hope and expectations that I welcome such a highly personalized therapeutic approach in addressing an urgent unmet need." Prof. Dr. Diehl founded the German Hodgkin Study Group and is a recipient of the Bundesverdienstkreuz (Order of Merit of the Federal Republic of Germany), awarded by the German government for his lifetime achievements in the field of lymphoma research.
The BiovaxID Phase III study results were recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, reporting that an eight year pivotal, randomized, multi-center, double-blind, controlled clinical study demonstrated that BiovaxID significantly prolonged disease-free
survival in follicular non-Hodgkin's lymphoma. The study 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 vaccine targeting lymphoma ever to demonstrate such a disease-free survival benefit and because the
vaccine is comprised of the patient's own cells (autologous), the therapy has been demonstrated to be safe and well-tolerated.
Later today, the BiovaxID Phase III study results will again be presented at the "Best of ASCO" event to be held at the Maison de la Chimie, in Paris, France at 4:15 p.m. local time. The iscussants for the BiovaxID abstract (abstract 33572) will be Jean-Luc Harousseau, M.D., Head of the Department of Clinical Hematology at the Central Laboratory of Hematology in Nantes, France and Vice President of the French Society of Hematology, and Christian Gisselbrecht, M.D., Ph.D., of the Institut d'Hematologie, Hopital Saint-Louis in Paris, France.
Prof. Dr. Diehl also anticipates that the addition of BiovaxID booster shots could substantially bolster patient results, stating, "The recently reported Phase III results, while impressive, did not include a BiovaxID maintenance regimen consisting of periodic booster shots. Such a maintenance booster regimen may be key in continuing to stimulate a robust and enduring immune response, thus further improving results, and perhaps even resulting in durable remissions for some patients." Biovest intends to include multiple booster vaccines for potential maintenance therapy purposes as part of the vaccine delivery for prescriptions processed under the named-patient program.
As BiovaxID is individually manufactured from a tissue biopsy obtained from a patient's own tumor, a patient wishing to participate in the named-patient program must undergo a lymph node biopsy prior to receiving chemotherapy/monoclonal antibody therapy. Those cells collected by biopsy will then undergo a preparation process performed by Biovest with the resulting
vaccine material then preserved until manufacture of the final vaccine is prescribed by the patient's physician through idis. The vaccine is typically administered approximately 6 months following the end of chemotherapy, and consists of five BiovaxID vaccinations, subcutaneously injected, over a 6 month
period (months 1,2,3,4 and 6). As an adjuvant therapy, at each vaccination cycle, patients will also receive four daily injections of an immune stimulating agent, GM-CSF. At the physician's option, a periodic vaccine booster maintenance regimen may also be prescribed.
A named-patient program is a compassionate-use drug supply program under which physicians are permitted to supply investigational drugs to qualifying patients. Under a named-patient program, investigational drugs may be administered to
patients who are suffering from a serious illness prior to the drug being approved by the European Medicines Evaluation Agency (EMEA). "Named-patient" distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient, assuming compliance with the local regulatory protocols respective to each participating
country. In Europe, under the named-patient program, the drug is most often purchased through the national health system.
Contact Information for BiovaxID Named-Patient Program:
Licensed hematologists can learn more regarding BiovaxID and the named-patient program by contacting:
idis Limited (United Kingdom)
Telephone: +44 (0) 1932 824 123
Fax: +44 (0) 1932 824 323
Email: internationalsales@idispharma.com
About BiovaxID(R)
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. 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 idis Limited
idis is the world leader in the development and implementation of named-patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. idis supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. For more information on idis please visit their website at http://www.idispharma.com.
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(TM), 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(R), 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.
GREAT NEW$ BVTI. This will be pay off real BIG.
Personalized Anti-Cancer Vaccine, BiovaxID(R), Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis
Jun 28, 2009 08:00:01 (ET)
TAMPA, Fla., Jun 28, 2009 (BUSINESS WIRE) -- --Phase III Study Results to Be Presented at "Best of ASCO" in Paris
Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), today announced that BiovaxID(R), Biovest's personalized therapeutic anti-cancer vaccine, is available on a named-patient (compassionate-use) basis in Europe. Following compliance with local regulatory protocols, BiovaxID will be supplied by idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin's lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Physicians in non-European countries may also contact idis to inquire about the potential availability of BiovaxID, as idis manages named-patient programs in more than 100 countries.
According to world-renowned hematologist and lymphoma research pioneer, Professor Volker Diehl, M.D., Ph.D., Professor of Medicine, University of Cologne, "With the availability of this truly patient-specific vaccine, I believe hematologists now have a new, safe lymphoma treatment option capable of enhancing existing chemotherapeutic and monoclonal antibody treatment options by training the patient's own immune system to selectively recognize and attack cancer cells, resulting in potentially longer lasting remissions. As follicular lymphoma so far is supposed to be a generally incurable and fatal blood cancer, it is with great hope and expectations that I welcome such a highly personalized therapeutic approach in addressing an urgent unmet need." Prof. Dr. Diehl founded the German Hodgkin Study Group and is a recipient of the Bundesverdienstkreuz (Order of Merit of the Federal Republic of Germany), awarded by the German government for his lifetime achievements in the field of lymphoma research.
The BiovaxID Phase III study results were recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, reporting that an eight year pivotal, randomized, multi-center, double-blind, controlled clinical study demonstrated that BiovaxID significantly prolonged disease-free survival in follicular non-Hodgkin's lymphoma. The study 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 vaccine targeting lymphoma ever to demonstrate such a disease-free survival benefit and because the vaccine is comprised of the patient's own cells (autologous), the therapy has been demonstrated to be safe and well-tolerated.
Later today, the BiovaxID Phase III study results will again be presented at the "Best of ASCO" event to be held at the Maison de la Chimie, in Paris, France at 4:15 p.m. local time. The discussants for the BiovaxID abstract (abstract 33572) will be Jean-Luc Harousseau, M.D., Head of the Department of Clinical Hematology at the Central Laboratory of Hematology in Nantes, France and Vice President of the French Society of Hematology, and Christian Gisselbrecht, M.D., Ph.D., of the Institut d'Hematologie, Hopital Saint-Louis in Paris, France.
Prof. Dr. Diehl also anticipates that the addition of BiovaxID booster shots could substantially bolster patient results, stating, "The recently reported Phase III results, while impressive, did not include a BiovaxID maintenance regimen consisting of periodic booster shots. Such a maintenance booster regimen may be key in continuing to stimulate a robust and enduring immune response, thus further improving results, and perhaps even resulting in durable remissions for some patients." Biovest intends to include multiple booster vaccines for potential maintenance therapy purposes as part of the vaccine delivery for prescriptions processed under the named-patient program.
As BiovaxID is individually manufactured from a tissue biopsy obtained from a patient's own tumor, a patient wishing to participate in the named-patient program must undergo a lymph node biopsy prior to receiving chemotherapy/monoclonal antibody therapy. Those cells collected by biopsy will then undergo a preparation process performed by Biovest with the resulting vaccine material then preserved until manufacture of the final vaccine is prescribed by the patient's physician through idis. The vaccine is typically administered approximately 6 months following the end of chemotherapy, and consists of five BiovaxID vaccinations, subcutaneously injected, over a 6 month period (months 1,2,3,4 and 6). As an adjuvant therapy, at each vaccination cycle, patients will also receive four daily injections of an immune stimulating agent, GM-CSF. At the physician's option, a periodic vaccine booster maintenance regimen may also be prescribed.
A named-patient program is a compassionate-use drug supply program under which physicians are permitted to supply investigational drugs to qualifying patients. Under a named-patient program, investigational drugs may be administered to patients who are suffering from a serious illness prior to the drug being approved by the European Medicines Evaluation Agency (EMEA). "Named-patient" distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient, assuming compliance with the local regulatory protocols respective to each participating country. In Europe, under the named-patient program, the drug is most often purchased through the national health system.
Contact Information for BiovaxID Named-Patient Program:
Licensed hematologists can learn more regarding BiovaxID and the named-patient program by contacting:
idis Limited (United Kingdom)
Telephone: +44 (0) 1932 824 123
Fax: +44 (0) 1932 824 323
Email: internationalsales@idispharma.com
About BiovaxID(R)
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. 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 idis Limited
idis is the world leader in the development and implementation of named-patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. idis supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. For more information on idis please visit their website at http://www.idispharma.com .
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(TM), 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(R), 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(R), AutovaxID(TM), 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.
SOURCE: Biovest International, Inc.
Biovest International, Inc.
Corporate Contact:
Douglas Calder, Director of Investor Relations & Public Relations
813-864-2554, ext.258
dwcalder@biovest.com
BVTI Moving up. Partnership and sales deal in EUROPE moving forward. Expecting an update from co soon. Link Back for DD.
ASCO- 2009 Updates- BVTI in Focus
Therapeutic Vaccine Delays Lymphoma Recurrence
While follicular lymphoma frequently responds to chemotherapy and can have a long course, the disease is considered incurable because it almost always recurs. Researchers of a lymphoma trial hope that BiovaxID, a personalized vaccine, could help delay those recurrences.
The study included 117 patients who experienced at least a six-month remission after chemotherapy, and retained that remission until receiving either BiovaxID or a control vaccine. Each patient randomized to the BiovaxID arm was given a series of injections of a vaccine developed from their own cancer cells, making it a specialized targeted drug against the individual’s malignant B cells. After a median of nearly five years follow-up, BiovaxID improved cancer-free survival by 47 percent, delaying recurrence for more than a year, from 30.6 months to 44.2 months, when compared with the control vaccine. No major differences in side effects occurred between the two arms.
Researchers stressed the need for future studies, including combining the vaccine with targeted drugs such as Rituxan (rituximab), an agent that is now a standard of care for lymphoma.
http://www.curetoday.com/index.cfm/fuseaction/article.show/id/2/article_id/1152
BVTI - Consolidated DD
1. Special Report( BVTI): Customized Cancer Vaccines Finally (Maybe) Arrive- Jun 12 2009, 12:00 AM EST
http://www.genengnews.com/news/bnitem.aspx?name=56088213
2. BVTI - BiovaxID sale in EU (Named Patient Program)
(Courtesy , Poster on Yahoo Message Board)
IDIS Pharma in EUROPE (http://www.idispharma.com/showcontent.asp?CollectionID=@0000000004) has started the sale
of BiovaxID in EU on compassionate use basis. If you know anyone with NHL, please forward them contact info
below.
Good luck to all,
=======================================
Dear XXX,
Thank you for your e-mail and I can confirm that IDIS has started the BiovaxID Named Patient Program, Please request that your physician contacts our Global Sales Team at IDIS, using the contact details below, if further information is required as IDIS is only permitted to deal with qualified and verified medics and medical facilities:
E-mail - globalsales@idispharma.com
Tel + 44 1932 824100
Fax + 44 1932 824300
Kind Regards
Colleen
3. BVTI: Presentation from European Society for Medical Oncology (ESMO)
http://www.esmo.org/fileadmin/media/presentations/826/LCT10001552.ppt
4. BVTI- PPT filed with the SEC- An important read
http://sec.gov/Archives/edgar/data/704384/000119312506152662/dex991.htm
Move to Slide # 10:
5.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."
6. Positive, Clinically Significant Phase III Results for Personalized Anti-Cancer Vaccine, BiovaxID(R),Presented at ASCO Plenary Session
Ref: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=38300750
7. BVTI- Media BUZZ
7.a. Story from ABC NEWS
http://www.abcnews.go.com/Health/CancerPreventionAndTreatment/story?id=7718919&page=1
7.b. Video from NBC NEWS
http://www.msnbc.msn.com/id/21134540/vp/31030637#31030637
7.c. Article from NY Times
http://www.nytimes.com/2009/06/01/business/01drug.html?ref=business
7.d. Article from Houston Chronicle
http://www.chron.com/disp/story.mpl/front/6451203.html
From BiomedReports
http://biomedreports.com/articles/most-popular/1099-pink-bio-play-may-move-markets-with-cancer-vaccine.html
8. BVTI: These are impressive results and may indicate that BiovaxID will be one of the first vaccines approved by the U.S. Food and Drug Administration.
Ref: http://professional.cancerconsultants.com/oncology_main_news.aspx?id=43607
I bought another 1500 shares today.....BVTI looks like it is ready to rebound!
I think BVTI is ready to make another run sometime soon....it looks like it has finally hit the bottom!
BVTI should make another run for it. Picked up a few shares today. We gotta get this board back to life
I bought some shares today....I think BVTI will make another run.....
I've never seen people trying to sell on news so fast before in my life.....Got my 10000 sold at 1.30!!!! missed the 1.45-50 action....weeeeeeeeeeeeeeeeee
Huge move coming today. Big news followed by a big move!!
BVTI and Accentia are both in chp 11
Im guesing thats because they are a bb now...
Historical shows no trades since January!
lets bring this board to life...just put in an order after selling 10,00 shares last month.
BVTI is now listed OTC BB. I don't see any Q yet. It's parent company is now ABPIQ. Maybe BVTI will be spared the Q.
Biovest International Announces Reorganization Plan to Maximize Long-Term Shareholder Value, Fully Pay All Creditors and Continue Operations to Commercialize its Drugs and Technologies
http://www.marketwatch.com/news/story/biovest-international-announces-reorganization-plan/story.aspx?guid=%7BDF0382A1%2D0943%2D4765%2DAA0F%2D6BFF28068708%7D&newsid=943266979&&dist=bigchartssymb=ABPIQ&sid=2034715
Date Insider Shares Type Transaction Value*
6-Oct-08 OSMAN RONALD E
Director 16,439 Direct Acquisition (Non Open Market) at $0.50 per share. $8,219
18-Sep-08 OSMAN RONALD E
Director 16,987 Direct Acquisition (Non Open Market) at $0.50 per share. $8,493
1-Aug-08 OSMAN RONALD E
Director 16,987 Direct Acquisition (Non Open Market) at $0.50 per share. $8,493
12-Jun-08 OSMAN RONALD E
Director 30,465 Direct Acquisition (Non Open Market) at $0.50 per share. $15,232
Form 8-K for BIOVEST INTERNATIONAL INC
29-Oct-2008
Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure.
The following information is being furnished under Item 7.01 of Form 8-K: Press release dated October 29, 2008, by the Company, titled "Biovest and IDIS Announce Agreement to Launch Named-Patient Program for Anti-Cancer Vaccine in Europe". A copy of this press release is attached as Exhibit 99.1 to this Form 8-K.
This Current Report on Form 8-K sets forth statements that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about BiovaxID®, the Named-Patient Program, AutovaxID™, Revimmune™, 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, the intent to treat analysis, accelerated approval and all aspects of 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 in this Form 8-K are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this Current Report on Form 8-K 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 plans cancer drug sales in EuropeTampa Bay Business Journal
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Biovest International Inc. said it has a distribution agreement to supply its personalized cancer vaccine in parts of Europe.
The vaccine, BiovaxID, will be sold under a named-patient program in France, Germany, Italy, Greece, Spain and the United Kingdom with sales expected to begin in the first quarter of 2009, said a release from Biovest (OTCBB: BVTI), a majority owned subsidiary of Accentia Biopharmaceuticals Inc.
Under a named-patient program, drugs that are pending approval can be administered to patients suffering from serious diseases until the drug is formally approved by the European Medicines Agency. BiovaxID will be made available to patients suffering from various B-cell related blood cancers including chronic lymphocytic leukemia, mantle cell lymphoma, multiple myeloma and non-Hodgkin’s lymphoma, the release said.
Biovest said its distribution agreement is with IDIS Limited, a company headquartered in the United Kingdom that specializes in sourcing and supplying medicines on a named-patient basis to European hospitals, pharmacies, physicians and patients.
Financial terms of the distribution agreement were not disclosed. Biovest said in the release that blood cancers represent an approximate $4 billion market opportunity in the United States and in Europe.
Accentia (NASDAQ: ABPI), a Tampa firm focused on development and commercialization of late-stage, targeted therapeutic clinical products, owns about 76 percent of Biovest’s common stock.
Biovest Reports Results for Patients Treated with Anti-Cancer Vaccine: BiovaxID(R) Demonstrates Clinically and Statistically Significant Improvement of Disease-Free Survival in Non-Hodgkin's Lymphoma in Pivotal Phase 3 Clinical Trial
Biovest Reports Blinded Results for Phase 3 Study Evaluating Anti-Cancer Vaccine, BiovaxID(R), which Shows 100% Difference in Disease-Free Survival at 36 Months in the Comparative Arms
Final Unblinded Results Are Expected to Confirm Efficacy Of BiovaxID for the Treatment of Non-Hodgkin's Lymphoma
TAMPA, Fla., Jun 11, 2008 (BUSINESS WIRE) -- Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today reported what the Company believes to be highly encouraging blinded results from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID(R) (anti-idiotype vaccine) for the treatment of indolent follicular non-Hodgkin's lymphoma (NHL), an often fatal blood cancer.
The Company reported blinded disease-free survival data for those patients that have completed 36 months of follow-up subsequent to randomization in both the treatment and control arms, with one arm demonstrating 100% improvement in disease-free survival over the other arm. Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study.
According to Steven Arikian, M.D., Chairman and CEO of Biovest International, "In the accompanying graph, one curve shows those patients at 36 months in the BiovaxID arm and the other curve shows those patients at 36 months in the control arm who received a non-specific immunostimulant (KLH/GM-CSF)."
See graph showing disease-free survival curves accompanying this release.
"Although these results are blinded, this data shows two distinct populations in the study, with unequivocal evidence of a difference in disease-free survival among the two arms. This is in direct contrast to previous anti-NHL vaccine failures which showed little difference between the treatment arm and the control arm. Based on the similar pattern to our Phase 2 data, we have a high degree of confidence that the cohort demonstrating superior disease-free survival represents the BiovaxID arm," stated Dr. Arikian.
Dr. Angelos Stergiou, Biovest's Vice President, Product Development, added, "We know that in our Phase 2 trial, the control arm showed a median disease-free survival of approximately 20 months, which is consistent with the inferior arm in our blinded Phase 3 results, and supports our strong belief that the group demonstrating clinical benefit is the BiovaxID arm."
About BiovaxID(R)
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, we anticipate that BiovaxID could potentially be used to treat other types of B-cell cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma.
About Biovest International, Inc.
Biovest International, Inc. (OTCBB:BVTI) is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., (NASDAQ:ABPI) 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(TM), which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID(R), 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
SOURCE: Biovest International, Inc.
CONTACT: Biovest International, Inc., Tampa
Douglas Calder, Director of Investor Relations
& Public Relations, 813-864-2554, ext.258
dwcalder@biovest.com
I guess this gives me another one to play LOL
Transactions — Last 2 Years
Trans Date Filer Ownership Type Price Shares
Apr 27, 2006 ACCENTIA BIOPHARMACEUTICALS INC
Beneficial Owner (10%) direct Disposition (Non Open Market) 0.6000 10,000,000
I think these shares are about ready to hit the market, this one won't get much higher if at all
Biovest Reports that Independent Data Monitoring Committee Recommends Unblinding of Phase 3 Clinical Results for its Anti-Cancer Vaccine, BiovaxID(R)
Thursday April 17, 8:00 am ET
Biovest to Present Data to FDA and Worldwide Regulatory Agencies in order to Seek Marketing Approvals
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (OTCBB:BVTI - News), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News), today announced that a key milestone has been achieved in the Company’s mission to gain approval for BiovaxID®, its personalized anti-cancer vaccine, in a pivotal Phase 3 Fast-Tracked clinical trial for the treatment of indolent follicular non-Hodgkin’s lymphoma.
Biovest reported that the independent Data Monitoring Committee (DMC), which is vested with the responsibility of monitoring the safety and efficacy of the BiovaxID trial, has completed a closed session review of the unblinded results, including the primary and secondary endpoints analysis of the Phase 3 study. Based on their analysis, the DMC has recommended that the results be unblinded, and has volunteered to participate, if needed, in Biovest’s ongoing regulatory meetings with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory agencies (Health Authorities) in order to determine the most appropriate process for unblinding the results, and establishing a pathway to seek marketing approvals.
The Chairman of the DMC, Dr. Gerald Messerschmidt, reported, "Our Committee has completed a closed session unblinded review of the interim Phase 3 safety and efficacy analyses regarding the BiovaxID registration study. Based on this review, the DMC recommends that the BiovaxID study be unblinded to the Company for final analysis. We further suggest that the final clinical study report include data, as part of Biovest's overall regulatory strategy of submission to the regulatory authorities, through August 29, 2008, which is the date when the last randomized and vaccinated patient reaches 12-months follow-up from first injection. While the DMC cannot release information on our closed session discussions, our recommendation to unblind this pivotal registration study in late-August is based on the status of the study, the defined safety profile over 8-years of this Phase 3 registration study and our review of the primary and secondary endpoint analyses. As part of the ongoing regulatory process, I as a representative of the DMC will relate our review of the closed session analysis of these interim data to Health Authorities as necessary.”
Responding to the DMC's recommendations, Biovest's Chairman and CEO, Dr. Steven Arikian, stated, "The DMC's diligent review has resulted in an excellent outcome for BiovaxID. Not only has the Committee reconfirmed the favorable safety profile for BiovaxID, but as importantly, we believe their recommendation to unblind and their willingness to meet with the regulatory authorities to discuss their findings suggests a successful trial outcome. In light of the DMC’s recommendation, we have already been in discussions with regulatory agencies, including the FDA, to seek consensus on the appropriate process for unblinding the results and establishing a pathway for potential accelerated and/or conditional approvals for BiovaxID. We also are coordinating with the EMEA regarding potential market access in Europe. If approved, Biovest will have distinguished itself as the first company to have its anti-cancer vaccine reach market in the U.S. or EU, a Herculean achievement. As this study was initiated in 2000, we now have the largest longitudinal database of lymphoma patients receiving a personalized therapeutic vaccine. 234 patients were enrolled and 177 randomized in the Phase 3 trial of which, two-thirds received BiovaxID therapy, and one-third control treatment. We believe that these long-term and highly anticipated results will demonstrate that BiovaxID is capable of prolonging the period of disease-free survival for an incurable form of non-Hodgkin's lymphoma, and in some cases, perhaps even inducing indefinitely prolonged, durable remissions."
As previously presented to the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO), the National Cancer Institute (NCI) demonstrated in a Phase 2 clinical trial that patients treated with BiovaxID achieved: a median disease-free survival of over eight years; a 95% overall survival rate after 9.2 years of follow-up; and a 95% cellular immune response. In this clinical trial, 73% of evaluable patients were converted into molecular remission (bcl-2 negative), evidence that their blood has been cleared of residual cancerous cells. BiovaxID also demonstrated an outstanding safety profile.
According to Dr. Angelos M. Stergiou, Biovest's Vice President, Product Development, Medical Affairs & Clinical Research, “This Phase 2 data, combined with our analysis of the blinded Phase 3 results, and the DMC’s recommendation to unblind, gives us a high level of confidence in unblinding the current Phase 3 study, both for efficacy and safety. If the results are highly positive, and assuming we are granted accelerated approval for BiovaxID, we would anticipate initiating a Phase 4, post-approval, clinical study for the purpose of collecting further efficacy and safety data.”
The primary end-point of the trial is a comparison between treatment groups, those that receive BiovaxID and those that receive a control. The study is looking at duration of disease-free survival measured from the time of randomization (i.e. when a subject is randomly assigned to receive BiovaxID or control) to the time of confirmed relapse.
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, we anticipate that BiovaxID could potentially be used to treat other types of B-cell cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma.
About Accelerated Approval under Subpart E (21CFR 601, Subpart E, Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses)
FDA may accelerate approval of certain new biological products for serious or life-threatening illnesses, with provisions for any necessary continued study of the drugs' clinical benefits after approval or with restrictions on use, if necessary. Subpart E is intended to provide expedited marketing of biological products for patients suffering from such illnesses when the biological products provide meaningful therapeutic benefit compared to existing treatments. Accelerated approval will be considered in two situations: (1) When approval can be reliably based on evidence from adequate and well-controlled studies of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients; and (2) when FDA determines that a drug, effective for the treatment of a disease, can be used safely only if distribution or use is modified or restricted. Drugs or biological products approved under these procedures must have met the requisite standards for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act (the act) or the Public Health Service Act (the PHS Act) and, thus, will have full approval for marketing.
About Biovest International, Inc.
Biovest International, Inc. (OTCBB:BVTI - News) is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., (NASDAQ:ABPI - News) 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 is currently conducting 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 Revimmune™, BiovaxID®, AutovaxID™, 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.
Contact:
Biovest International, Inc., Tampa
Douglas Calder, Director of Investor Relations
& Public Relations, 813-864-2554, ext. 258
Email: dwcalder@biovest.com
or
Susan Bonitz, Ph.D., Director, Program Coordination
813-864-2554, ext. 277
Email: sbonitz@accentia.net
--------------------------------------------------------------------------------
Source: Biovest International, Inc.
This one is getting ready to take off!
I WAS WRONG. IT STAYED RED WHEN I CHANGED SYMBOLS
can't find it. are you sure????
NEWS MY SCREEN WENT RED.
little healthy consolidation today. WEEEEEEEEEEEEEEE!!!!
Nice read Blue, I believe your right. eom
As you can see in the chart above, the ASI or Accumulation Swing Index has turned VERY positive - meaning that major accumulation is underway. The RSI has not even hit 90 yet so IMO we still have A LOT more room to go up. And the MACD and EMA is headed into KA-BOOOM zone!!!!
Per the recent SEC filing covering the marketing and distribution/sales agreement Biovest has to deliver its AutovaxID™ Products and Services starting in 2 weeks:
Addendum A
Product Listing
AutovaxID™ Products and Services
US Ordering Information, 2007
5/16/2007
Part Number Description Price, USD VWR
Instrument 25 %
600285-120
AutovaxID™ Automated Cell Culture System 39,950.00 29,962.50
Includes instrument, barcode scanner, power cord, gas connection fittings, and refrigerator rack for factor bags.
Flowpath Options 25 %
600290-211
AutovaxID Flowpath with one 1.1m2 bioreactor 3,450.00 2,587.50
600290-221
AutovaxID Flowpath with one 2.1m2 bioreactor 3,500.00 2,625.00
Optional Disposables 25 %
600017-000
10 L Glass Media Bottle (package of four) 1,608.00 1,206.00
600022-000
Cap Assembly, Fluid Delivery, for 10 L Media Bottle (package of four) 243.00 182.25
600023-000
Cap Assembly, Fluid Collection, for all Media Bottles (package of four) 243.00 182.25
600063-000
Sterile In-line Media Filters, mid-volume (four each, one per sterile pack) 406.00 304.50
600063-001
Sterile In-line Media Filters, high-volume (four each, one per sterile pack) 879.00 659.25
600100-072
1/16” Sterile Tubing Extension, recommend 5 per AutovaxID flowpath 47.00 35.25
600101-072
1/8” Sterile Tubing Extension, recommend 1 per AutovaxID flowpath 59.00 44.25
600294-000
Supernatant Sterile Tubing Extension, recommend 1 per AutovaxID flowpath 45.00 33.75
UHGW00026
20L Bag, ICS (basal medium) feed or spent medium collection. Quantity of six. Single-use to eliminate cleaning requirements. 109.00 81.75
600288-000
AutovaxID Factor Bag Set. Spare Set. 710.00 532.50
Optional Services 25 %
500077-000
AutovaxID installation and initial operator training (1 day on site.) 3,500.00 2,625.00
500078-000
In house operator training (3 days on site, training for up to 4 persons) 4,500.00 3,375.00
500074-000
Installation Qualification and Operational Qualification 6,600.00 4,950.00
500073-000
Full Service Contract 8,000.00 6,000.00
Full Service Contract: One-year coverage for one AutovaxID for workmanship and materials of the instrument during normal use. Includes repair or replacement of defective parts at Biovest’s discretion. Labor is included if installation of repaired/replaced part is not routine. Includes up to two trips per year per facility for service. Parts shipment costs are not included. If no repair service has been necessary near the end of the contract coverage, one trip may be used for annual calibration.
500079-000
Laboratory system demonstration 13,500.00 10,125.00
30 day AutovaxID run at Minnesota facility. Customer provides media and supplements.
Page 23 of 23
--------------------------------------------------------------------------------
Addendum B
VWR Marketing Plan
1. Differentiated Supplier Status: As a differentiated supplier at VWR, Biovest will have the highest possible profile within our organization. Our executive management and sales team is given a higher focus and visibility on the sale of Biovest products, than other non-differentiated suppliers. The number of suppliers in this top tier is limited by VWR.
2. VWR Life Science: The Biovest product range will be part of our “Preferred Supplier” program within the VWR Life Science Category. This program is supported by 31 Life Science Sales Specialists in North America, 3 Sales Directors, 1 Category Manager and 1 Marketing Manager. The Life Science sales team has a higher compensation rate on our “Preferred Suppliers”.
3. Web Site: Preferred placement of Biovest products with supporting literature, application notes and technical information on VWR.com. Biovest products will be given a priority “weighting” during product searches, so that the Biovest products come up first in all related product searches.
4. Publications: VWR will promote AutovaxID products in their publications described in a presentation sent to Biovest on May 16, 2007
5. Sales Conversion Programs: Participation in sales conversion programs at VWR target accounts including Pharma, Biotech, Academic and Medical Research customers.
6. Priority Training and Meeting Participation: Biovest will be invited to participate in all VWR sales meeting (National, regional and local) as well as having the opportunity to provide training to the 450 VWR sales associates and 31 Life Science Specialists in North America.
Well if you actually READ the SEC filings you would know WHY there is a run here and WHY it will continue - clearly from your post you fail to realize that Biovest’s AutovaxID device is being sold and marketed in the US for the first time in the coming weeks. We won't even get into the BiovaxID anti-cancer vaccine (which is the only thing you seem to be addressing):
Item 7.01. Regulation FD Disclosure.
The following information is being furnished under Item 7.01 of Form 8-K:
a. Press release, dated June 5, 2007, by Biovest International, Inc. announcing the Company’s decision to apply for accelerated conditional approval for commercial sale of its BiovaxID anti-cancer vaccine. A copy of this press release is attached as Exhibit 99.1 to this Form 8-K;
b. Press release, dated June 12, 2007, by Biovest International, Inc. announcing entry into a Non-Exclusive Distribution Agreement with VWR International, Inc. for marketing and distribution of Biovest’s AutovaxID device. A copy of this press release is attached as Exhibit 99.2 to this Form 8-K;
c. Press Release dated June 13, 2007 by Biovest International, Inc. announcing that an interim analysis of data from the Company’s ongoing Phase 3 Clinical Trial of its anti-cancer vaccine, BiovaxID, will be conducted at the request of the independent Data Monitoring Committee. A copy of this press release is attached as Exhibit 99.3 to this Form 8-K.
Item 8.01. Other Events.
On June 8, 2007 Biovest entered into a Non-Exclusive Distribution Agreement with VWR International, Inc. (“VWR”) to market and distribute its breakthrough AutovaxID™ automated cell culture device in North America. VWR plans to begin its sales and marketing activities in July 2007. The initial term of this Distribution Agreement is 24 months, and, unless earlier terminated by either party at the expiration of the then current term upon not less than 90 days’ prior notice, shall thereafter renew automatically for additional and successive terms of 12 months each.
http://www.sec.gov/Archives/edgar/data/704384/000119312507135663/d424b3.htm
This seems to be awfully premature run here boys....
The drug looks very promising indeed but the FDA approval process from testing and FDA evaluation and eventual approval could easily take well into the 4th. quarter 2008 minimum...
I think patience is in order here..... This looks to be 3x overvalued at the moment... I think I might just sit back and wait for it to return to normal valuation.... This is a real long play here that might even take several years to come to fruition.... This play will require patience to pay off big...
Agree. big boys are all over this stock now that we broke a dollar. Can't wait for this week. :D
Great day to close at $1.03! Next week we are on our way to $1.50 and expected to see some nice PRs.
Nice dip here. Great entry. Looking forward to next week.
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http://www.biovest.com
Biovest International Inc, is a majority-owned subsidiary of Accentia Biopharmaceuticals Inc., a vertically-integrated specialty biopharmaceutical company with services to commercialize targeted therapeutics. Accentia is a publicly traded company (NASDAQ: ABPI) that has a product portfolio featuring targeted therapeutics, specialty sales and marketing, pharmacoeconomic services, product development, and specialty distribution.
Biovest has a deep foundation in the manufacture of biological drugs from small research scale quantities to large volumes for Phase I and Phase II clinical material. In addition, Biovest International develops, manufactures, and markets patented cell culture systems and equipment to pharmaceutical, diagnostic and biotechnology companies, as well as leading research institutions worldwide. For over 10 years the company has operated the National Cell Culture Center (NCCC) under a grant from the National Institutes of Health.
Biovest is the holder of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute for the commercialization of BiovaxID, a personalized biologic therapeutic cancer vaccine for the treatment of non-Hodgkin's lymphoma. This therapy, referred to as BiovaxID, is currently in a phase 3 pivotal trial at 24 major medical institutions in the US.
SEC FILINGS
http://phx.corporate-ir.net/phoenix.zhtml?c=154286&p=irol-sec
RECENT NEWS
http://finance.yahoo.com/q?s=BVTI.OB
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